SSF Standard Operating Procedures

Document Number: BMC-SOP-1

Title: Developing Policies, Standard Operating Procedures, Work Instructions, Forms and Templates

Revision: 10.0

Effective Date: 12 Dec 2024

Supersedes Date: 26 Apr 2021

Author: Janet Price-Lutz, 13 Nov 2024

Approver: Jenna York, 13 Nov 2024

Approver: Robert Orr, 25 Nov 2024

Quality Assurance: Jennifer Marsh, 10 Dec 2024

1.0 PURPOSE

1.1 This Standard Operating Procedure (SOP) outlines the process for creating and formatting Policies, SOPs, Work Instructions (WI), Forms and Templates at the Biospecimen Management Core (BMC).

2.0 SCOPE

2.1 This SOP applies to all BMC Policies, SOPs, WIs, Forms and templates developed for functions that are performed at BMC in accordance with ISBER “Best Practices” and GxP regulations as required.

3.0 ROLES & RESPONSIBILITIES

Area Management (AM)

• Ensures that personnel follow the content and formatting requirements in this SOP for the creation or revision of controlled documentation.
• Designated appropriate representatives to review changes to documents in a timely manner.

Author

• Creates Policies, SOPs, WIs and associated Forms and Templates according to the content and formatting requirements outlined in this SOP.

Quality Assurance (QA)

• Reviews Policies, SOPs, WIs and associated Forms and Templates for compliance to the content and formatting requirements outlined in this SOP.

BMC Personnel

• Identify all processes that are performed by BMC personnel and need standardization through the creation of Policies, SOPs, WIs, Forms and Templates.

4.0 REFERENCES AND RELATED DOCUMENTS

• BMC-SOP-06 Controlled Document Management
• BMC-TMP-01 Standard Operating Procedure (SOP) Template
• BMC-TMP-02 Work Instruction (WI) Template
• BMC-TMP-03 Form Template
• BMC-TMP-04 Policy Template
• International Society for Biological and Environmental Repositories (ISBER) Best Practices – current edition

5.0 DEFINITION OF TERMS

• Form – Controlled document with fields designed for data/information input.
• Policy – A standard written at a high-level describing a corporate philosophy, approach or requirement.
• Standard Operating Procedure (SOP) – A written set of instructions that describes how to perform an activity to ensure consistency and reliability.
• Template – Controlled document which is modifiable and may have instructions for completion.
• Work Instruction (WI) – A more detailed written instruction for a specific activity. Work Instructions provide individuals with step-by-step information to perform a job properly and facilitate consistency in the quality and integrity of a procedure or end result.

6.0 PROCEDURE

6.1 Document Identification

6.1.1 Follow BMC-SOP-06 to obtain a unique identifier for documents.

6.2 Policy, SOP and WI Format (see BMC-TMP-04, Policy Template; BMC-TMP-01, SOP Template; and BMC-TMP-02, WI Template, respectively)

6.2.1. Header: The pre-printed header on every page of each Policy, SOP or WI contains the prearranged format that includes:

Document type (Policy, SOP, WI)

Document title

Document number

Revision number

Supersede date

Effective date

Page x of y

For WI Only: Governing SOP number

6.2.2 On the first page of each Policy, SOP or WI, include a signature approver table as exemplified in BMC-TMP-04, BMC-TMP-01, and BMC-TMP-02.

6.2.3 Appendix: Include in the body of the Appendix:

Appendix identifier, e.g., Appendix A

Title of the Appendix

Note: Header continues from the document.

6.2.4 Create documents using font “Times New Roman”, 12 point.

6.2.5 Information or steps under each section are organized by a sequential numbering system as exemplified in this document.

6.2.6 Outline the intended content to develop a logical and sequential flow of ideas and avoid repeating information both within a single document and across multiple documents.

6.2.7 State the referenced document type and number when referencing another document within the text of the document. Do not reference the version number of the document.

6.2.8 Spell out abbreviations and acronyms the first time they are used in a document unless they are so common as to be universally understood (e.g., GDP).

Use the full text with abbreviation in parenthesis in the first location in the document; the abbreviation may then be used alone thereafter within the document.

6.2.9 Place a zero (0) in front of the decimal point for numbers less than one, e.g., 0.25 inches, to reduce the possibility of misreading numbers if the decimal point is poorly printed.

6.2.10 Bold the words “Note”, “Caution” and “Warning” and capitalize the first letter of the word. Write notes, cautions or warning statements in the specific section/step of the document where the guidance applies.

6.3 Document Content for SOPs, WIs, and Policies

6.3.1 Use BMC-TMP-01 to create SOPs, BMC-TMP-02 to create WIs, and BMC-TMP-04 to create Policies.

6.3.2 Controlled documents are written with the following sections, in order, except where noted.

Purpose

Scope

Roles and Responsibilities

References and Related Documents – All documents referenced in the Policy, SOP or WI

Definition of Terms

Reagents and Materials (optional) – only SOPs and WIs

Equipment (optional) – only SOPs and WIs

Standards (optional) – only SOPs and WIs

Safety (optional)

Procedure – This section provides guidance and instructions on how to perform the procedure.

Appendices – All graphs, tables, examples, etc. (optional)

Revision History (Prior to the actual Appendices) – Details all of the changes from the previous approved document

6.4 Form Format

6.4.1. Use BMC-TMP-03 to create forms in Word.

6.4.2 If creating forms in other software programs (i.e., Excel®), wherever possible, use the BMC logo. At a minimum, specify that it is a “BMC” Form (in the form title or form header) and have the following elements on the form:

Form Number and Revision

Effective Date of the Form

Page x of y

6.4.3 Divide forms into clearly useable sections and design them to minimize numerous entries of “Not Applicable” (N/A)

6.4.4 Use borderlines to separate sections to ensure accuracy and placement of entries.

6.4..5 If the form needs to include restricted fields that can be completed electronically, use the Restricted Formatting and Editing feature in Microsoft Word to create the necessary form fields.

6.5 Template Format

6.5.1 When creating a new template, refer to section 6.2.

6.5.2 If creating templates in other software programs (i.e., Excel), wherever possible, use the BMC logo. At a minimum, specify that it is a “BMC” document (in the template title or header) and have the following elements in the template footer:

Template Number and Revision

Page x of y (may be located in header, as appropriate)

6.5.3 Design templates to be modifiable. Include instructions within the body of the sections of the template or as a cover page to the template to assist users in using the template.

6.5.4 Use different color text for instructions so users of the template know what text is modifiable, removed or left unchanged.

6.6 Document Change Control

6.6.1 BMC-SOP-06 outlines instructions for the tracking and change control management for Policies, SOPs, WIs, Forms and Templates.

7.0 APPENDICES

7.1 Not applicable

8.0 REVISION HISTORY

Revision No.	Section	Change Description	Date
10.0	All sections	Complete overhaul of SOP to update format, clarify content, move definitions to a central glossary and separate template(s) into separate documents to be managed independently of the SOP. Updated numbering format; formerly SF-1-01.	Current See D-23-08
9.0	See SF-1-01	See SF-1-01	26 Apr 2021

 

Document Number: BMC-SOP-05

Title: Personnel Training

Revision: 11.0

Effective Date: 12 Dec 2024

Supersedes: 15 Mar 2021

Author: Janet Price-Lutz 20 Nov 2024

Approver: Jenna York 22 Nov 2024

Approver: Robert Orr 25 Nov 2024

Quality Assurance: Jennifer Marsh 10 Dec 2024

1.0 PURPOSE

1.1 The purpose of this procedure is to describe how training is assigned, conducted and documented at the Biospecimen Management Core (BMC)

2.0 SCOPE

2.1 This Standard Operating Procedure (SOP) applies to any employee, consultant or contractor who performs a function at the BMC in accordance with current GxPs or ISBER regulations.

2.2 This SOP and associated forms can be used as a guide and record of training for functions that do not fall under the scope of this SOP, if necessary.

3.0 ROLES & RESPONSIBILITIES

Area Management (AM)

• Generates, signs and dates Job Descriptions for BMC personnel and provides a copy to QA.
• Notifies QA of any New Hires and provides the required information.
• Coordinates new hire training with QA.
• Performs Company Introduction.
• Ensures that personnel in their areas are trained prior to performing any GxP processes.
• In collaboration with QA, creates and updates training plans as roles change or get updated.

Authors

• Complete form BMC-FRM-06 identifying the Reviewers and Approvers of the document.
• Work with Area Management to identify Trainees and training requirements and document them on form BMC-FRM-06.
• Submit completed form to QA.

Facility Manager

• Develops and maintains organizational chart and provides it to QA upon being updated.

Quality Assurance (QA) or designee

• Coordinates new hire training with AM.
• Provides training documentation to Qualified Trainer/Subject Matter Expert (SME) or Area Manager, as needed.
• Provides training on BMC’s Quality Systems, as needed.
• Provides or schedules GxP training.
• Manages and maintains employee training files.
• With AMs, create Individual Training Plans for each BMC trainee, CBP trainee, contractor or consultant (as needed).

Qualified Trainer or Subject Matter Expert (SME)

• Trains trainees or contractors, as applicable.
• Creates or revises training assessments.
• Reviews completed training assessments, as necessary.

Trainees

• Following this procedure when completing BMC Standard Operating Procedures.
• Sign Job Descriptions, as applicable.
• Provide resume/CV to QA for filing in the appropriate training file, as applicable.

4.0 REFERENCES AND RELATED DOCUMENTS

• BMC-FRM-01 Document Change Request Form
• BMC-FRM-02 Individual Training Form
• BRM-FRM-03 Multiple Trainee Training Form
• BRM-FRM-04 Multiple Read and Understand Training Form
• BRM-FRM-06 Training for Document Change Requests Form
• BRM-FRM-09 Record of Signature and Electronic Signature Agreement Form
• BMC-TMP-05 Training Assessment Template
• BMC-SOP-03 Good Documentation Practices
• BMC-SOP-04 Document Distribution and Archiving
• BMC-SOP-06 Controlled Document Management
• BMC-SOP-13 Record of Signature, Electronic Signature Agreement and Signature Delegation
• N/A International Society for Biological and Environmental Repositories (ISBER) Best Practices – current edition

5.0 DEFINITION OF TERMS

• Administrative Change – Changes made to an effective document which does not change the intent/purpose and/or responsibilities that are deemed to be minor in nature, e.g. adding a new SOP/WI category, fixing typographical errors, formatting.
• Trainee – A BMC employee, Collaborating Biobank Personnel (CBP), or contractor (as applicable) who, per their job function or as noted on the company’s curriculum, needs to be trained on executing the specific tasks outlined within a document before it can be made effective.
• GxP – Good practice regulations associated with the development of drug/biological products, e.g., current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
• ISBER – International Society for Biological and Environmental Repositories
• On the Job Training (OJT) – On-the-job training (OJT) is a form of training where the trainee watches the actual task being performed by the trainer. OJT is an interactive hands-on training method that can be used for training on equipment maintenance, for example.

6.0 PROCEDURE

6.1 Description of Training Levels

Note:  The level of training required is governed by the type of document, the employee’s or contractor’s or consultant’s (as applicable) job function and previous training or experience.

Note: Administrative changes made to controlled documentation do not necessitate training.

6.1.1 Read and Understand Training

6.1.1.1 At a minimum, procedures related to job responsibilities require Read and Understand training.

6.1.1.2 Read and Understand trainings may fall into the following categories:

Documents that provide general instructions in the conduct of BMC processes.

Individual has been trained in a previous version and current document has not had major changes to content.

Informational literature, such as materials obtained at or from a conference.

6.1.1.3 Document training using Forms BMC-FRM-02 (Individual Training Form), 03 (Multiple Trainee Training Form), or 04 (Multiple Read and Understand Training Form).

Note: BMC-FRM-04 is used when trainee is training on multiple documents that require Read and Understand training. This form cannot be used for any other type of training.

6.1.1.4 Trainee signs and dates the form and forwards it to QA when complete.

6.1.1.5 Trainee’s signature and date designate the effective date of training.

6.1.2 Lecture/Instructor Led Training

6.1.2.1 The AM, in collaboration with the Author, determines the need for Lecture/Instructor Led training.

6.12.2 Lecture/Instructor Led training may be required for complex procedures, On-the-Job Training (OJT) formats, or multi-step procedures that require use of controlled forms.

6.1.2.3 If presentation materials are handed out or created in-house, QA files any hardcopy and/or electronic copies in QA.

6.1.2.4 Document training using BMC-FRM-02 or 03 depending on if one or multiple trainees are trained.

6.1.2.5 Trainee and Trainer sign and date the form. The Trainer forwards to QA when complete.

Note: If the Trainer’s signature cannot be obtained, as in the case of an off-site training, check the “Not Available” box and attach any associated handouts or certificates.

6.1.2.6 Trainee’s signature and date designate the effective date of training.

6.1.3 Training Assessments

6.1.3.1 The trainer in collaboration with the Am determines the need for an assessment as part of training.

Note: All Standard Operating Procedures require assessments.

6.1.3.2 The Author and/or Trainer design the assessment to accurately reflect the material being presented.

6.1.3.3 The Author or Trainer creates the assessment in the format shown in BMC-TMP-05, Training Assessment Template.

6.1.3.4 Trainees must achieve ≥80% to pass an assessment.

6.1.3.5 Trainees have a maximum of 3 attempts to achieve a passing grade. If a trainee fails the third attempt, an Instructor re-trains the Trainee (see 6.1.2).

6.1.4 BMC Personnel New Hire Orientation and Training

6.1.4.1 Area management notifies QA of any BMC New Hires and provides the following to QA.

Name

Start date

Title

Manager’s name

6.1.4.2 BMC New Hire orientation and training occurs during the individual’s first two weeks of employment and includes:

A company introduction (as applicable)

Providing a signed and dated resume to QA. Resume/CV must include your current position at BMC.

Signing and dating individual’s Job Description (as applicable) and providing it to their Manager for signature.

BMC SOP training as defined in training matrix.

6.1.4.3 During the employee’s/contractor’s/consultant’s (as applicable) first week, QA, in collaboration with AM, initiates a training curriculum based on the New Hire’s job responsibilities.

6.1.4.4 Upon completion of signing and dating the Job Description, the New Hire’s Manager provides the completed document to QA for filing into the appropriate training file.

6.1.5 SSF Collaborating Biobank Personnel (CBP) Training

6.1.5.1 The Collaborating Biobank (CB) notifies Area Management of CBP requiring SSF facility access.

Form SF-2-3 Appendix E required

Verify that access requested aligns with the CBs equipment housed in the SSF (i.e. CB with no MRU housed in the SSF cannot request personnel be trained to access MRU rooms.)

6.1.5.2 Within one week of receipt of SF-2-3 Appendix E, QA, in collaboration with the New Hire and/or the New Hire’s AM, initiates a training curriculum based on access requested via SF-2-3 Appendix E.

6.1.5.3 Area Management notifies QA of any CBP New Hires and provides form BMC-FRM-09 (Record of Signature and Electronic Signature Agreement Form) to QA upon training completion. AM provides the completed training documents to QA for filing into the appropriate training file.

6.1.6 Contractor and Consultant Training

6.1.6.1 QA maintains files for all contractors/consultants involved in conducting or advising on operations at the BMC.

6.1.6.2 Contractor/Consultant files minimally consist of:

Name and contact information of contractor/consultant

Description of services to be provided to the BMC such as Consulting Agreement, Service Agreement, job description, etc.

6.1.6.3 Contractors/Consultants only advising the BMC on operations, are not required to complete training or attend BMC’s SOP trainings.

6.1.6.4 Contractors are required to complete SOP trainings in addition to the training required per their job function or as noted on the company’s curriculum.

6.1.7 SSF Collaborating Biobank Personnel Annual Training

6.1.7.1 Training on critical on safety and security procedures occurs annually. QA conducts or arranges the training.

6.1.7.2 SSF CBP employees and contractors (as applicable) receive annual safety and security training to ensure understanding of how safety and security directives apply in the BMC.

6.1.7.3 Annual training may consist of a lecture, seminar, webinar or course and may include a training assessment.

6.1.7.4 Document training on BMC-FRM-02 or 03.

6.1.8 Webinars and Off-Site Training

6.1.8.1 Document webinar and off-site trainings on BMC-FRM-02 or 03.

6.1.8.2 Attach copies of handouts and/or certificates obtained during the training to the training form and forward to QA for filing.

6.2 Qualified Trainer or SME Requirements

6.2.1 The employee/contractor (as applicable) demonstrates the education, relevant work experience, training or a combination thereof, to enable them to train others or be considered a SME.

6.2.2 The employee/contractor (as applicable) demonstrates their Qualified Trainer or SME capabilities through their resume, publications or documented training.

6.2.3 QA maintains a list of Qualified Trainers and SMEs for all documents.

6.3 Documentation of Subject Matter Experts (SMEs) and Individual Company Training Requirements

6.3.1 When the Author requests a Document Change Request (DCR) (BMC-FRM-01) for an SOP, QA provides the Author with BMC-FRM-06 (Training for Document Change Requests Form) in addition to the DCR.

6.3.1.1 Individuals identified in Part B of BMC-FRM-06 were involved in the writing and/or review of the document and are considered trained and, where appropriate, SMEs.

6.3.1.2 The Author, with Area Management, completes Part C which identifies Essential Trainees, individual/role/department training requirements and the level of training.

6.3.2 Upon completion of creation or revision of the document, forward the DCR and BMC-FRM-06 to QA.

6.3.3 QA provides training forms and assessments (if necessary) to the trainees/departments identified on Part C of BMC-FRM-06.

6.3.4 Upon completion of training, Trainees forward forms to QA for filing.

6.4 BMC Personnel Role Changes/Updates

6.4.1 If any employee changes roles within the company, QA, in collaboration, with the employee’s AM, updates their training curriculum based on their new job responsibilities, as needed.

6.4.2 The AM provides QA an updated Job Description to file in the employee’s training file.

6.4.3 The employee submits an updated resume including updated responsibilities to QA for filing in the appropriate training file.

6.4.4 The employee submits an updated form BMC-FRM-09, Record of Signature and Electronic Signature Agreement Form, to QA to reflect their new role.

6.5 Collaborating Biobank Personnel (CBP) Role Changes/Updates

6.5.1 Upon notification by employee or employee’s AM that CBP change roles within their biobank, QA, in collaboration, with the employee’s AM, updates their training curriculum based on their new job responsibilities, as needed.

6.5.2 CBP submit an updated form BMC-FRM-09, Record of Signature and Electronic Signature Agreement Form, to QA to reflect their new role.

6.6 BMC Personnel Training Records Maintenance

6.6.1 QA maintains training files in a restricted access location for all active BMC employees who perform tasks within the scope of this SOP. At a minimum, these training files include:

A resume which includes employee’s current BMC responsibilities along with employee’s signature or initials and date submitted.

Current job description with employee’s and manager’s signature

Signature record (BMC-FRM-09; see BMC-SOP-13)

Certifications and/or licenses, as applicable

BMC training, as applicable

Record of training from external training seminars/courses, if applicable

Record of training received at BMC

6.6.2 QA files training forms by document type (as defined in BMC-SOP-06, SOP for Controlled Document Management) and revision number.

6.6.3 QA copies forms used for multiple trainee trainings and files one in each trained employee’s file.

6.6.4 QA retains training records of former employees according to BMC-SOP-04, SOP for Document Distribution and Archiving.

6.7 Collaborating Biobank Personnel (CBP) Training Records Maintenance

6.7.1 QA maintains training files in a restricted access location for all active CBP who perform tasks within the scope of this SOP. At a minimum, these training files include:

Signature record (BMC-FRM-09, see BMC-SOP-13).

Record of training received at BMC

6.7.2 QA files training forms by document type (as defined in BMC-SOP-06) and revision number.

6.7.3 QA copies forms used for multiple trainee trainings and files on in each trained employee’s file.

6.7.4 QA retains training records of former employees according to BMC-SOP-04.

6.8 Organizational Chart, Training Matrices, Individual Training Plans, and Training Tracking

6.8.1 The Facility Manager creates and maintains a current organizational chart(s) which shows the reporting relationships for all employees/consultants/contractors and their job functions.

The organizational chart(s) is updated on a n as needed basis by the Facility Manager and a copy provided to QA.

6.8.2 BMC Personnel Training Matrix: Create a Training Matrix for each functional area.

6.8.2.1 Each matrix contains the following sections:

Job Description (JD)

CV/Resume

Signature Record

BMC training requirements

Job Specific training requirements

6.8.2.2 The Area Manager, or designee, in conjunction with QA determines the training requirements for each job description/title.

6.8.3Collaborating Biobank Personnel (CBP) Training Matrix: Create a Training Matrix for each functional area based on access requested per SF-2-3 Appendix E.

6.8.3.1 Each matrix contains the following sections:

Signature Record

SSF access-specific training requirements

6.8.3.2 The Area Manager, or designee, in conjunction with QA determines training requirements for each CBP per access requested via SF-2-3 Appendix E.

6.8.4 Individual Training Plans: Area Managers, with QA, assign Individual Training Plans to each employee/CBP/contractor/consultant performing a BMC operation.

6.8.5 Training Tracking: Use the Training Tracking spreadsheet to track the training status by SOP and version # for each individual within a functional area.

6.8.5.1 The Training Tacking spreadsheet contains a list of all the SOPs on the Training Matrix and each individual working within a specific functional area.

6.8.5.2Upon receipt of completed training forms, QA updates the Tracking Training spreadsheet with the date indicated on the training form and files all hard copies of training documentation within the appropriate individual’s training file as indicated in Sections 6.6-6.7.

7.0 APPENDICES

7.1 Not Applicable.

8.0 REVISION HISTORY

Revision No.	Section	Change/Description/Justification	Date
11.0	All Sections	Complete overhaul of SOP to update format, clarify content, move definitions to a central glossary and separate Forms and Template into separate documents to be managed independently of the SOP. Applied new numbering format. Formerly SF-1-05.	Current See D-23-08
10.0	See SF-1-04	See SF-1-05	15 Mar 2021

Document Number: BMC-SOP-13

Title: Record of Signature, Electronic Signature Agreement and Signature Delegation

Revision: 0.0

Effective Date: 12 Dec 2024

Supersedes: First issue

Author: Janet Price-Lutz 20 Nov 2024

Approver:  Jenna York 22 Nov 2024

Approver: Robert Orr 25 Nov 2024

Quality Assurance: Jennifer Marsh 10 Dec 2024

1.0 PURPOSE

To define the system used at the Biospecimen Management Core (BMC) to collect a record of signature, electronic signature agreement and document signature delegation for individuals working in regulated functions within BMC.

2.0 SCOPE

This procedure applies to all BMC personnel, including temporary and contract associates working in a regulated function or any BMC personnel participating in regulated activities that have signature authority for controlled documentation, and Collaborating Biobank Personnel (CBP) trained per BMC-SOP-05 (Personnel Training SOP) and working in a regulated function in the BMC.

3.0 ROLES & RESPONSIBILITIES

BMC Employees

• Complete BMC-FRM-09, Record of Signature/Electronic Signature Agreement form, if working in regulated areas.
• Submit a new Record of Signature/Electronic Signature Agreement form when signature changes.

Collaborating Biobank Personnel (CBP)

• Complete BMC-FRM-09 if working in regulated areas.
• Submit a new Record of Signature/Electronic Signature Agreement form when signature changes.

Delegate

• Confirms signature delegation is established and effective prior to signing.
• Attaches copy of effective signature delegation form to documents upon signing on behalf of delegator.
• Fulfills training requirements, as needed, prior to signing on behalf of delegator.

Delegator

• Completes BMC-FRM-10, Signature Delegation form, upon initiation, revision, or revocation of signature delegation.
• Submits a new Signature Delegation form when changes are required.

Quality Assurance (QA), or designee

• Maintains employee Record of Signature/Electronic Signature Agreement forms.
• Ensures Delegate training is conducted, as necessary.
• Assists in securing signature delegations.
• Submits an executed copy of BMC-FRM-10 to the system owner as notification that delegation during the specified time period is active.

4.0 REFERENCES AND RELATED DOCUMENTS

• BMC-FRM-09 Record of Signature/Electronic Signature Agreement
• BMC-FRM-10 Signature Delegation
• BMC-SOP-05 Personnel Training

5.0 DEFINITION OF TERMS

• Delegate – One who has been given signature authority on behalf of another individual and is qualified to review and sign the document(s) that have been identified on the Signature Delegation Form.
• Delegator – One who gives signature authority to another individual to review and sign documents.
• Designee – An individual who performs a specific role or duty when documents are delegated.
• Electronic Signature – An individual’s electronic authenticated credentials which have the same meaning as the individual’s handwritten signature.
• Record of Signature – A document completed to record the handwritten signature of personnel who complete controlled documentation.
• Signature Delegation – The process of one employee delegating their signature authority to another employee for a particular process or task.

6.0 PROCEDURE

6.1 Record of Signature

6.1.1 Personnel working in regulated areas within the BMC or participating in regulated activities provide QA with a completed Record of Signature/Electronic Signature Agreement form (BMC_FRM-09).

Note: An updated Record of Signature/Electronic Signature Agreement form is required to be completed and sent to QA when changes are necessary (e.g. name change).

6.1.2 QA or designee maintains BMC-FRM-09 in the employee’s Training File within QA.

6.2 Signature Delegation

6.2.1 Complete BMC-FRM-10, Signature Delegation Form, to delegate signature authority for the completion of controlled documentation and/or activities to document your agreement that the Delegate may sign on your behalf.

6.2.2 When required, QA works with BMC personnel to secure signature delegation when the signatory is out of the office and cannot sign.

6.2.3 Complete BMC-FRM-10 to retract/revoke your signature delegation.

6.2.3.1 Delegators retract delegated signing authority to Delegates who have changed roles or functional areas for which they are delegated signature authority.

6.2.3.2 Document retractions are not required for personnel no longer working at the BMC.

6.2.3.3 If a former employee is listed as a delegate for any existing employee, revise BMC-FRM-10 to remove the former employee’s name.

6.2.3.4 Prior to signing on behalf of another individual, verify the Signature Delegation is active.

6.2.4.1 Delegates confirm the delegation by contacting QA.

6.3 Requirements for Signature Delegation

6.3.1 If the Delegate is not within the same functional area or department as the individual delegating their authority, the person delegating their signature provides rationale on the Signature Delegation Form.

6.3.2 Prior to signing as a delegate, a Delegate fulfills all training requirements appropriate to the task being performed.

6.3.3 List specific document(s) or actions for which signature delegation is appropriate on BMC-FRM-10. It is not acceptable to specify “all documents”.

6.3.4 Signature delegation is not required when someone at the same level or above performs the same function and they have fulfilled all training requirements related to the process for which they are signing.

6.3.5 A Delegate signs documents or performs activities identified on BMC-FRM-10 in one of the following formats:

John Smith “on behalf of” Jennifer Doe

John Smith “for” Jennifer Doe

6.4 Signature Delegation as it pertains to Computer Systems

6.4.1 For computer systems that have a mechanism for capturing signature delegation follow the system’s documented procedures.

6.4.2 If the computer system does not have a mechanism or a documented procedure for handling signature delegation, complete BMC-FRM-10. Requirements defined in Step 6.3 are applicable.

6.4.2.1 Give an executed copy of BMC-FRM-10 to the system owner as notification that delegation during the specified time period is active.

6.5 Filing Process for Record of Signature/Electronic Signature and Signature Delegations

6.5.1 Personnel send completed BMC-FRM-09 or BMC-FRM-10 forms to QA or designee for verification.

6.5.2 QA or designee maintains the completed Record of Signature form (BMC-FRM-09) in the employee’s training file according to BMC-SOP-05.

6.5.3 QA or designee files the completed original Signature Delegation form (BMC-FRM-10) in the Delegator’s training file according to BMC-SOP-05.

6.5.4 QA or designee files a copy of the Signature Delegation form (BMC-FRM-10) in the Delegate’s training file.

7.0 APPENDICES

7.1 Not applicable.

8.0 REVISION HISTORY

Revision No.	Section	Change Description	Date
0.0	N/A	New document to provide instructions for documenting employee’s signature, electronic signature and delegation of signature	Current

Document Number: BMC-SOP-06

Title: Controlled Document Management

Revision: 9.0

Effective Date: 12 Dec 2024

Supersedes: 31 Jan 2022

Author: Janet Price-Lutz 20 Nov 2024

Approver: Jenna York 20 Nov 2024

Approver: Robert Orr 25 Nov 2024

Quality Assurance: Jennifer Marsh 10 Dec 2024

1.0 PURPOSE

1.1 This Standard Operating Procedure (SOP) describes the process for the life cycle management of controlled documentation.

2.0 SCOPE

2.1 This SOP applies to the Biospecimen Management Core (BMC) documents and records supporting facility operations involving current GxPs; in addition to quality systems documentation subject to regulatory inspections.

3.0 ROLES & RESPONSIBILITIES

Approver

• Reviews and approves documentation. When multiple departments approve documentation, approval by a given department indicates agreement with, and the ability to comply with, only those requirements in the documentation applicable to that department and within the scope of that department’s assigned responsibilities.
• Notifies the Author and Quality Assurance (QA) immediately if any part of the document is unacceptable and requires resolution before approval.

Area Manager

• Reviews and approves/declines obsolescence requests.

Author

• Creates, evaluates, and revises all the controlled documents required within the scope of their responsibility.
• Works with QA to assign appropriate Approvers.
• Obtains a document number from QA.
• Resolves comments from Reviewers for internal or vendor-controlled documents.

BMC Employees, Contractors and Consultants (as applicable)

• Follow all applicable BMC SOPs, Policies and other applicable controlled documentation when conducting business on behalf of BMC.
• Follow this SOP for the writing, revising, approval and/or obsolescence of controlled documents.

Quality Assurance (QA) or designee (where indicated)

• Assigns document numbers, if applicable.
• Verifies proper document structure, format, and referencing.
• Provides notification of effective documents.
• Reviews and approves controlled documentation.
• Works with Author to assign Approvers for documents.
• Oversees and manages life cycle maintenance of documents within the Quality System.
• Ensures training is conducted and recorded on controlled documents, if applicable.

Reviewer

• Reviews document and provides input to the content of the document.

4.0 REFERENCES AND RELATED DOCUMENTS

• BMC-FRM-01 Document Change Request Form
• BMC-TMP-06 Table of Contents Template
• BMC-SOP-05 Personnel Training
• BMC-SOP-04 Document Distribution and Archiving
• BMC-SOP-13 Record of Signature, Electronic Signature Agreement and Signature Delegation
• N/A International Society for Biological and Environmental Repositories (ISBER) Best Practices – current edition

5.0 DEFINITION OF TERMS

• Administrative Change – Change made to an effective document which does not change the intent/purpose and/or responsibilities and are deemed to be minor in nature, e.g. adding a new SOP/WI category, fixing typographical errors, formatting.
• Author/Originator – The person who writes the text of the procedure or who initiates revisions to the document.
• Effective status – An approved, controlled document where training has been completed.
• Trainee – An employee who, per their job function or as noted on the facility’s curriculum, needs to be trained on executing the specific tasks outlined within a document.
• GxP – Good practice regulations associated with the development of drug/biological products; e.g., current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
• Standard Operating Procedure (SOP) – An SOP is a written set of instructions that describes how to perform an activity to ensure consistency and reliability.
• Work Instruction (WI) – A WI is a more detailed written instruction for a specific activity. Work Instructions provide individuals with step-by-step information to perform a job properly and facilitate consistency in the quality and integrity of a procedure or end result.

6.0 PROCEDURE

6.1 Document Identification

6.1.1 QA assigns document numbers

6.1.2 Document Refix: Assign each document a BMC prefix for Biospecimen Management Core.

6.1.3 Department Designation (as needed): For SOPs that are specific to a department within the BMC add one of the department designations listed below.

 

Acronym	Department
CTSL	Clinical and Translational Sciences Laboratory
SSF	Specimen Storage Facility

 

6.1.4 Document Type: Assign each document a document type according to the categories outlined in the table low:

 

Acronym	Document Type
MAN	Manual
POL	Policy
PST	Posting
SOP	Standard Operating Procedure
WI	Work Instruction
FRM	Form
PRO	Protocol
RPT	Report
TMP	Template

 

6.1.5 Document Number: Lastly, assign each document a unique two-digit sequential number beginning with 01 for each document type within a department.

6.1.6 Document Revision Number: The Revision Number follows the format N.N. The first revision number (i.e., initial version) is 0.0 for each document.

6.1.7 The resulting document number resembles:

AAA-XXX(X)-YY(Y)-NN

Where:

AAA – Document Prefix – BMC

XXX(X) – Department (as needed)

YY(Y) – Document Type

NN – increasing sequential number

Example: The fifth work instruction issued in the CTSL is BMC-CTSL-WI-05 Revision 0.0.

6.2 Document Format and Content

6.2.1 Documentation format and content is defined within specific SOPs related to each Document Type.

6.3 Document Change Control

6.3.1 Initiation of a New Document or Revision of an Existing Document

6.3.1.1 Author requests a document number and a Document Change Request (DCR form, BMC-FRM-01) from QA.

6.3.2 Tracking

6.3.2.1 QA tracks document change controls through the use of DCRs sand the DCR log (maintained by QA).

6.3.2.2 QA assigns a DCR Number to each document change request and identifies the type of change as follows:

New

Revision (Permanent Change)

Administrative

Obsolete

Periodic Review

6.3.2.3 Change request numbers are in the format DCR-XX-NNN where:

XX: Corresponds to the last two digits of the current calendar year

NNN: Is a sequential number beginning with 001

6.3.2.4 Record all change requests in the DCR Log. The DCR Log contains, at a minimum, areas for the following:

DCR number

Date of DCR request

Document number

Document type

Prepared by

Document title

Effective date of the changed document

6.3.2.5 QA assigns a document identification number to new documents and edits the format of the new document for compliance with this procedure.

Note: The “Supersedes Date” for a new document is “First issue”.

Note: The “Supersedes Date” for a revised document is the prior version’s Effective Date.

6.3.2.6 QA submits the DCR, a draft copy of the document to be revised or an appropriate template (as available) if the document is new, and any applicable documents to the individual preparing/revising the document.

6.4 New documents

6.4.1 Any individual can initiate a request for a new document.

6.4.2 The Author drafts the document by either using a template provided by QA or by creating a draft using the recommended formatting for the specific document type being created.

6.4.2.1 The Author forwards the draft document to the appropriate stakeholder(s) for review.

6.4.3 Upon completion of the review, the Author forwards the draft document to QA with Parts A and B of the DCR completed to initiate document tracking and change control according to Step 6.3.

6.4.4 QA verifies that the document type and format meet the requirements of document control procedures.

6.4.5 QA also verifies that regulatory or harmonized standards, appropriate to the work, have been consulted and followed.

6.4.6 Once QA completes their review, the document and the DCR are circulated for final signature approval.

Note: QA may void any DCR that has not been approved in a timely fashion without justification. All paperwork (i.e. DCR, training documentation) must be returned to QA for tracking purposes.

6.5 Revised Documents

6.5.1 The Author requests a copy of the current version of the document from QA and initiates a DCR (see 6.3.1).

6.5.2 The Author revises the document using Track Changes and forwards it to the appropriate stakeholders for review.

6.5.3 Upon completion of the revision, the Author forwards the revised document to QA with Parts A and B of the DCR completed to document tracking and change control according to Step 6.3.

6.5.4 QA verifies that the document type and format meet the requirements of corporate document control procedures.

6.5.5 QA also verifies that regulatory or harmonized standards, appropriate to the work, have been consulted and followed.

6.5.6 Once QA completes their review, the document and the DCR are circulated for final signature approval.

6.6 Administrative Changes

6.6.1 Administrative changes are handled in the same fashion as outlined above with the exception that the document’s Revision Number goes through a minor increase, instead of a major increase, e.g. 1.0 increases to 1.1 instead of 2.0.

6.7 Final Document Review and Approval

6.7.1 QA or designee generates a final version of the document for signature approval and routes it for approval.

6.7.2 QA or designee and the Author determine which Departments are responsible for approval based on their responsibility/scope in the document.

6.7.3 If an approver is not available to sign the document, a delegate may sign provided the appropriate signature delegation documentation is in place according to BMC-SOP-13, Record of Signature, Electronic Signature Agreement and Signature Delegation.

6.7.4 All references need to be effective for the document to be made effective.

6.8 Training

6.8.1 The effective date should be set allowing a reasonable time for affected trainees to be trained (typically three weeks after document approval).

6.8.2 Conduct training according to BMC-SOP-05, Personnel Training.

6.8.3 All individuals authoring and reviewing/approving the document are considered trained. Update training records according to BMC-SOP-05, Personnel Training to reflect this.

6.8.4 Not all document types require training, refer to BMC-SOP-05, Personnel Training for instructions on how to designate training requirements.

6.8.5 Administrative changes do not require training.

6.9 Obsolete Document

6.9.1 Author contacts QA to initiate a DCR as outlined in Step 6.3.

6.9.2 Author identifies the change as obsolete on the DCR by completing Parts A and B and forwards the DCR to an Area Manager for review and approval.

6.9.3 The Area Manager reviews and either approves, and signs the DCR, or denies the approval of the change by not signing the DCR and forwards the DCR to QA for authorization or rejection and archiving.

6.9.4 QA or designee closes out the DCR by entering document obsolescence date in the DCR Log, removing the document from use and archiving all paperwork according to BMC-SOP-04, Document Distribution and Archiving.

6.10 Periodic Document Review

6.10.1 Perform periodic lifecycle reviews every three years on the following document types: SOPs, Work Instructions, Policies, Forms, Templates and Manuals.

6.10.2 QA initiates the DCR according to Step 6.3 and forwards it with a copy of the document to the appropriate Reviewer(s) given the document content.

6.10.3 Upon completion of the review, the completed DCR and document are returned to QA for final processing.

6.10.4 If there is no change necessary, QA or designee updates the Revision History and routes the document for signatures.

Note: If no changes are made, the Effective Date and the Revision Number stay the same. Document that no changes are required on the DCR, DCR log and the SOP binder Table of Contents (BMC-TMP-06).

6.10.5 QA updates the Periodic Review Date in the DCR Log.

6.10.6 If a change to the document is necessary, revise the document according to Step 6.5.

6.11 Final Document Preparation

6.11.1 QA verifies that the approved document and all required training is complete.

6.11.2 QA adds the effective date to each page of the approved document as required.

6.11.3 QA enters the current effective date and revision number into the Master Documents List.

6.11.4 QA or designee places the hard copy of the effective document bearing the original signatures in a secured location according to BMC-SOP-04, Document Distribution and Archiving.

6.11.5 QA closes out the DCR by entering the document effective date in the DCR Log and QA or designee distributes and archives all paperwork according to BMC-SOP-04, Document Distribution and Archiving.

6.11.6 Form Preparation

6.11.6.1 QA sets permissions on final electronic versions of Forms to allow for electronic entry of data in fields on the locked Word form. Headers, wording, signature/date fields and overall structure of the document cannot be altered.

6.11.7 QA or designee places the final electronic version of the document in a secure network folder.

6.11.8 QA or designee makes only PDF copies of documents available in a shared network folder, with the exception of forms and templates (refer to BMC-SOP-04).

7.0 APPENDICES

7.1 Not applicable

8.0 REVISION HISTORY

Revision o.	Section	Change Description/Justification	Date
9.0	All Sections	Complete overhaul of SOP to update format, clarify content, move definitions to a central glossary and separate Form into separate documents to be managed independently of the SOP. Moved some content related to distribution and archival into separate SOP and applied new numbering format. Formerly SF-1-06.	Current See D-21-08
8.0	See SF-1-06	See SF-1-06	31 Jan 2022

 

Document Number: BMC-SOP-04

Title: Document Distribution and Archiving

Revision: 0.0

Effective Date: 12 Dec 2024

Supersedes Date: First issue

Author: Janet Price-Lutz 25 Nov 2024

Approver: Jenna York 25 Nov 2024

Approver: Robert Orr 25 Nov 2024

Quality Assurance: Jennifer Marsh 10 Dec 2024

1.0 PURPOSE

This document describes the procedure for the internal distribution and archiving of the Biospecimen Management Core (BMC) approved documents, and postings. In addition, this procedure provides instructions for the external distribution of BMC documentation.

2.0 SCOPE

This Standard Operating Procedure (SOP) applies to all BMC controlled records that support the BMC processes, operation of BMC archives, and applicable training.

3.0 ROLES & RESPONSIBILITIES

BMC Personnel

• Create documents.
• Submit documents to QA for distribution and archiving.

Quality Assurance (QA) or designee

• Distributes and archives documents.
• Adds security and document settings to each document.
• Verifies the proper distribution and archival of documents.
• Verifies accuracy and completeness of documents prior to distribution and archiving.
• Verifies document destruction criteria is met and approves destruction.

4.0 REFERENCES AND RELATED DOCUMENTS

• BMC-FRM-01 Document Change Request Form
• BMC-FRM-05 Interim Archive (Off-Site) Storage Log
• BMC-FRM-07 Document Distribution Form
• BMC-FRM-08 Permanent Archive Removal Log
• BMC-FRM-15 Archive Sign-out Log
• BMC-FRM-25 Document Digitizing Verification Form
• BMC-SOP-03 Good Documentation Practices
• BMC-SOP-06 Controlled Document Management
• BMC-TMP-06 Table of Contents Template
• Indiana University Research Data Management Policy (current version) – HRPP Policy – Research data management: Human Subjects & IRB: Policies: RESEARCH: Indiana University (iu.edu) – https://research.iu.edu/policies/human-subjects-irb/research-data-management.html
• N/A International Society for Biological and Environmental Repositories (ISBER) Best Practices – current edition

5.0 DEFINITION OF TERMS

• Record – A document stating results achieved or providing evidence of activities performed.

6.0 PROCEDURE

6.1 Issuing Documents

6.1.1 Manage controlled documents according to BMC-SOP-06, SOP for Controlled Document Management.

6.2 Distribution and Archiving of BMC Documents

Note: QA, or designee, performs the tasks outlined in Step 6.2. A second individual within QA (or a designee) performs the tasks outlined in Step 6.3.

6.2.1 User Books

Generate as many copies for the User Books as needed. Ensure the copies are clean representations of the original Principal document.

Identify each document as a copy with a watermark “Copy”, or stamp.

Generate an updated version of the Table of Contents (BMC-TMP-02). Ensure the current date is updated and printed on the Table of Contents.

Complete Part A1 of BMC-FRM-07, Document Distribution Form, listing all the approved documents to be distributed to the User Books and/or obsolete documents to be removed.

Distribute the documents to the indicated User Books and remove any superseded or obsoleted documents, as needed.

Attach any superseded or obsoleted documents to BMC-FRM-07.

6.2.2 Network Distribution of PDF Documents

QA, or designee, creates a PDF copy of the document, if necessary.

Set document security properties to restrict changes to documents.

Note: A Password is not required to open the document but is required to edit.

Set ‘Changes Allowed’ permissions to “none” except for any required response sections.

When printing documents that are to be used for reference or other purposes where they will not be placed in controlled binders, folders, or User Books, add an “Uncontrolled Copy” watermark and a Print Date to the document. Format the settings so that the watermark and Print Date appear when the document is printed.

Note: Uncontrolled copies of printed documents are only considered valid for 24hrs after the date printed. Always check to make sure you are using the most current version of a document.

Word versions of documents

Documents available in Word version include Forms and Templates.

Do not add watermarks or print date to Forms and Templates as data is entered into these document types.

Save Forms with ‘Restricted Access’ status to prevent inadvertent overwriting of the document.

Complete BMC-FRM-07, Part A2 listing all the approved documents moved to the appropriate document folders located in the network, the QA Backup (One Drive) and the BMC Website.

Note: Only QA, or designee, has permission to save, delete and modify documents in the approved document folders.

Move all superseded and obsolete PDF documents to the appropriate archive document folders located on the QA Backup (One Drive).

Note: Only QA, or designee, has permission to save, delete and modify documents in the archive document folders.

6.2.3 Distribution of Forms and Postings

Generate as many copies of Forms and/or Postings as needed for the Satellite areas. Ensure the copies are clean representations of the original Principal document.

Complete Part A3 of BMC-FRM-07 listing all the approved Forms and/or Postings to be distributed to the Satellite areas and/or obsolete Forms and/or Postings to be removed.

Distribute the Forms and/or Postings to the indicated Satellite areas and remove any superseded or obsoleted Forms and/or Postings, as needed.

Attach any superseded or obsoleted Forms and/or Postings to BMC-FRM-07.

6.2.4 Update the Master Document List and place the hard copy of the effective document bearing the original signatures in a secured, fireproof filing cabinet.

6.2.5 Forward the executed copy of BMC-FRM-07 to a second individual in QA (or a designee) for verification.

6.3 Document Distribution/Archiving Verification (BMC-FRM-07, Parts B1-B3)

6.3.1 QA, or designee, verifies that the indicated documents have been distributed or archived to the proper User Books and network folders as listed on Parts A1-A3 of BMC-FRM-07. Document the verification in BMC-FRM-07, Parts B1-B3.

6.3.2 QA, or designee, verifies the accuracy of the document security settings.

6.3.3 QA, or designee, verifies placement of the original effective document in a secured, fireproof filing cabinet.

6.3.4 If the distribution is complete and accurate, QA, or designee, completes Parts B1-B3 of BMC-FRM-07, destroys the superseded and obsoleted copies of documents, and archives the completed form in QA.

6.3.5 If the distribution is incomplete or inaccurate, QA, or designee, completes Part C of BMC-FRM-07 and returns it to the individual who performed the distribution for corrections, then, once corrections have been made, repeats Steps 6.3.1 -6.3.4.

Document acceptance of the corrected distribution/archiving in Part D of BMC-FRM-07.

6.4 Hardcopy Record Maintenance and Archival

6.4.1 Attach the Document Change Request Form (DCR), BMC-FRM-01, to the Master or the original document and store hardcopies in restricted access fireproof filing cabinets.

6.4.2 As documents are superseded, stamp or write “Superseded” across the first page of the superseded document and file behind the new Master.

6.4.3 Document Obsolescence

Stamp or write across first page “Obsolete”

Attach the fully executed DCR to the obsoleted document.

File the package in restricted access fireproof filing cabinets.

6.5 Document Retention

6.5.1 All documents are archived in the BMC archive for the minimum retention periods defined in Appendix A.

6.6 Digital Document Retention

6.6.1 Documents required to be digitized prior to relocation to off-site storage or destruction are defined in Appendix A.

6.6.2 Record documents scanned or confirmed digitized on BMC-FRM-25, Document Digitizing Verification Form.

6.6.3 Verification

6.6.3.1 Prior to off-site storage relocation (completed per Section 6.7) or document destruction (completed per Section 6.8), BMC personnel verify digitized documents as directed on BMC-FRM-25.

6.6.3.2 Document the verification on BMC-FRM-25.

Note: Verification that all content on the source document is included in the scanned document includes confirming that any comments near the edges of documents are captured in the scanned document.

6.7 Interim Off-Site Archive

If storage space in the fireproof cabinets is needed, documents may be moved off site for intermediate storage prior to destruction.

6.7.2 On-site retention for all documents is defined in Section 6.5 and Appendix A.

6.7.3 Manage off-site storage using an IU-approved vendor.

6.7.4 Store archive documents off-site according to the Indiana University Research Data Management Policy (current version), and per the following requirements:

Use standard letter-paper width banker’s boxes.

Complete BMC-FRM-05, Interim Archive (Off-Site) Storage Log, with a detailed list of documents for off-site relocation.

Barcode each box with Barcode labels and record the barcode number on BMC-FRM-05.

For ease of reference and organization, number each box sequentially as recorded on BMC-FRM-05.

6.7.5 Electronically store a completed copy of BMC-FRM-05 in a limited access shared folder within the CTSIProcessingLabs folder.

6.7.6 Store the hardcopy version of the completed form in the Document Control Binder within the BMC Operations Management Office.

6.7.7 Prior to off-site storage relocation, BMC personnel conduct a 100%% verification of the Off-Site Storage Log for data entry accuracy.

Document the verification on BMC-FRM-05.

6.7.8 A second BMC individual completes a 10% check of each line item in BMC-FRM-05 and documents the review on BMC-FRM-05.

6.7.9 Document removal to offsite storage on BMC-FRM-15, Archive Sign-out Log.

6.7.10 Upon verifying accuracy, request pickup from the IU-approved vendor.

6.7.11 Requesting delivery of boxes to the vendor and return of boxes previously stored at the vendor requires the BMC vendor account number and barcode of each box.

Re-approval/re-verification is not required for the return of these boxes.

6.8 Document Destruction

6.8.1 When the archive retention period outlined in Appendix A has been met, documents may be destroyed.

6.8.2 Following the retention period, notify PIs of specimen-related document destruction, and if requested, provide the documentation to them.

6.8.3 Complete BMC-FRM-08, Permanent Archive Removal Log, with a detailed list of documents for destruction.

6.8.4 Prior to moving documents to destruction, BMC personnel must conduct a 100% verification of BMC-FRM-08 and each document to verify retention period and data entry accuracy. Document the verification on BMC-FRM-08.

6.8.5 A second BMC individual completes a 10% check of each line item in BMC-FRM-08 and documents the review on BMC-FRM-08.

6.8.6 The Archivist documents destruction on BMC-FRM-15, Archive Sign-out Log.

Retain this form indefinitely in the Document Destruction Binder.

Use a printed copy of the manifest to detail each document removed. Attach to BMC-FRM-15.

6.8.7 QA approval required prior to document destruction. Refer to BMC-FRM-08.

6.8.8 Upon receipt of QA approval, BMC Management requests destruction of boxes already stored at the vendor. The BMC vendor account number and barcode of each box is required.

6.9 Requesting Archived Documents

6.9.1 Request archived documents from QA, or designee.

6.9.2 QA, or designee, records removal of archived materials on BMC-FRM-15, Archive Sign-out Log. Record date, requestor, Material Check out, and issuer initials, and forwards the materials to the Requestor.

6.9.3 Upon return of materials, QA, or designee, records return date in the BMC-FRM-15 and returns materials to the archives.

7.0 APPENDICES

7.1 Appendix A: Minimum Record Retention Requirements

Page 1

Page 2

Page 3

8.0 REVISION HISTORY

Revision No.	Section	Change Description	Date
0.0	N/A	New document outlining the process for the distribution and archiving of controlled documentation. SSF Controlled Document Management SOP SF-1-6 will be retired once BMC-SOP-04 and BMC-SOP-06 are effected.	Current See D-23-08

 

Document Number: BMC-SOP-03

Title: Good Documentation Practices

Revision: 0.0

Effective Date: 12 Dec 2024

Supersedes Date: First issue

Author: Janet Price-Lutz 25 Nov 2024

Approver: Jenna York 25 Nov 2024

Approver: Robert Orr 25 Nov 2024

Quality Assurance: Jennifer Marsh 10 Dec 2024

1.0 PURPOSE

1.1 The purpose of this Standard Operating Procedure (SOP) is to define acceptable practices for completion of records at the Biospecimen Management Core (BMC).

2.0 SCOPE

2.1 This procedure is applicable to BMC personnel, SSF Collaborating Biobank personnel as defined in Steps 2.1.1-2.1.2. This procedure satisfies guidance set forth in ISBER “Best Practices” as related to Good Documentation Practices.

2.1.1 If the SSF Collaborating Biobank has their own Good Documentation Practices procedure a copy of their procedure will be requested by the SSF Director to maintain on file.

2.1.2 Personnel of SSF Collaborating Biobanks which do not have their own Good Documentation Practices will comply with BMC-SOP-03 by training on BMC-SOP-03 Appendix A.

3.0 ROLES & RESPONSIBILITIES

BMC personnel – Responsible for following this procedure when completing BMC documentation.

SSF Collaborating Biobank Personnel – Responsible for following this procedure when completing BMC documentation as directed in Section 2.1.

Quality Assurance (QA) and Reviewers – Responsible for reviewing BMC documentation for accuracy, completeness and compliance to this procedure.

4.0 REFERENCES AND RELATED DOCUMENTS

• BMC-SOP-04 Document Distribution and Archiving
• BMC-SOP-13 Record of Signature, Electronic Signature Agreement and Signature Delegation
• BMC-FRM-09 Record of Signature/Electronic Signature Agreement
• N/A International Society for Biological and Environmental Repositories (ISBER) Best Practices –  current edition

5.0 DEFINITION OF TERMS

• ALCOA – Attributable, Legible, Contemporaneous, Original and Accurate
• Appendices – Supplementary material attached at the end of the original document.
• Backdating – The practice of attributing an earlier completion date to information which had been entered previously but not adequately initialed and dated at the time of entry, so it appears as if documentation occurred at the time work was originally completed.
• GDP – Good documentation practices
• GxP – Good practice regulations associated with the development of drug/biological products, e.g., current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
• Laboratory Notebook – Hard-covered book with a sewn/sturdy binding and sequentially numbered pages.
• Memoranda – A communication that contains directive, advisory, or informative matter.
• N/A – Not applicable
• Performed By – Individual that executed the defined task.
• Recorded By – Individual that recorded data on BMC documents.
• Reviewed By
  • Person who ensures the record is correctly completed and in accordance with the Good Documentation Practices.
  • Person who assesses recorded data to verify correctness against pre-defined requirements.
• Signature, Electronic – An individual’s electronic authenticated credentials which have the same meaning as the individual’s handwritten signature.
• Signature, Handwritten – A handwritten mark of an individual in a manner consistent with the employee’s signature record per BMC-SOP-13.
• Verified By – Identifies the person who is responsible for proving that specified requirements have been fulfilled, through confirmation of information/data by examination, and supported by objective evidence.

6.0 PROCEDURE

6.1 Requirements for written data entry on BMC documents

6.1.1 Follow ALCOA principles when making entries. Ensure entries are:

Attributable – Able to be ascribed to a particular individual.

Legible

Contemporaneous – Recorded at the time of the event.

Original – Record actions on any unofficial document at the time of event occurrence.

Accurate.

6.1.2 Use indelible (smear and water0resistant) black or blue ink.

Felt-tip markers, pencils, gel or erasable pens are not permissible.

6.1.3 Make entries on BMC document (e.g., visitor log, form) in the space provided or within an appropriate location.

6.1.4 Recording data on Post-it notes, paper scraps, gloves, or legal pads is not acceptable.

6.1.5 When entering or correcting data, do not use arrows, ditto marks, and/or symbols in lieu of the actual data value. All information must be recorded to sufficiently describe the information which is being recorded.

6.1.6 Record the associated units of measure, unless already defined in the data field. Common abbreviations can be used to document units (e.g., “°” for degree, “C” for Celsius).

6.1.7 Report data to be clear and traceable so that review by multiple reviewers result in consistent interpretation.

6.1.8 Where the original data is not included, report data identifying the approved and archived raw data source.

6.1.9 Recorded data must be complete and include all required information.

6.1.10 Include complete data from all work performed.

6.1.11 When data is obtained from an instrument, record the instrument identification (ID).

6.1.12 When a review or verification of recorded data is required, someone other than the person(s) who recorded the data conducts the review or verification.

6.2 Late Entry

6.2.1 Use the current date when preparing documents and entering information—Do not back-date or date documents in advance.

Note: Backdating is fraudulent. Provide an explanation for the delay to substantiate the delayed entry.

6.2.2 If missing or late data is discovered during a review of the quality record, the data can be entered provided:

The missing data can be corroborated.

The person who performed the task or their manager provides the data.

Include an explanation as to why the data is missing.

6.3 Original Data

6.3.1 Do not obliterate, erase, write over or discard data and/or information.

6.3.2 If original data are recorded anywhere other than the prescribed document, retain the information by attaching it to the original document. When unable to attach data because of amount see section 6.4. Adhere to all requirements regarding attachments.

All data, including supporting data, if applicable, must be permanently affixed to or referenced on the appropriate document.

6.3.3 In the event where the original source document becomes illegible, attach it to a new copy of the same form with the data transcribed.

6.3.3.1 Reference the original form on the new form, noting that the data has been transcribed from the original with a reason (e.g., original form illegible).

6.3.3.2 Add a footnote to the original form indicating that the data has been transcribed to the new form with the same reason (e.g., data illegible, transcribed to new form, attached).

6.3.4 In the event that a copy of an original document is required, clearly label the photocopy, “COPY”.

This is not required in the event of a photocopy of an existing document previously stamped or documented as a COPY.

6.3.5 Identify documents used as examples for training with “For Training Purposes Only”.

6.4 Criteria for Attachments to Documents

6.4.1 Affix attachment(s) in a secure manner (staple, tape, sleeve protector, etc.) to the appropriate governing document without obscuring any information. Minimize folding of attachments where possible.

6.4.1.1 Identify and link all documentation, including any attached references to the primary record by ensuring sufficient pertinent information is recorded on documents to trace references to their source.

6.4.1.2 Sequentially number each attachment.

6.4.1.3 Label each page of each attachment(s) with page X of Y. Pagination of Attachments do not need to be included in the pagination of the parent record.

6.4.1.4 When affixing labels, post-it notes, etc. to an attachment, initial and date the addition. Ensure that a portion of the initial and date overlap onto both the affixed item and the attachment page.

6.4.2 When it is not possible to affix certain types of materials (data packages, notebooks, etc.), ensure that the governing document refers to the location of the separate material, and the separate material references the document with which it is associated.

6.5 Use of Signature and/or Initials on BMC Documents

6.5.1 Document your signature and/or initials in a manner consistent with our employee signature record per BMC-SOP-13.

6.5.2 Staff are not permitted to sign for another member of staff unless delegated per BMC-SOP-13.

6.5.3 Document only the work that you perform.

Note: Recording data for another employee is considered falsification of records. When you sign or initial a document, you are accepting responsibility for the task as referenced in the document.

6.5.4 A valid signature may be handwritten or electronic.

Signatures must be traceable to an individual employee per the employee’s Record of Signature and Electronic Signature Agreement form BMC-FRM-09.

If the person’s first and last name in the signature is not legible, the person’s first and last name must also be printed in the record and clearly associated with that signature.

6.5.5 Whenever a signature is recorded, a date is also required.

6.5.6 Where a full signature is required, initials alone are not permitted unless specifically allowed by the document/procedure and a full signature appears in the same document.

6.5.7 Individuals “performing”, “recording”, “verifying” or “reviewing” activities related to Quality Records comply with the requirements outlined under the definition for each role.

6.5.8 The signatory may not use dittos, and/or symbols in lieu of an actual signature.

6.5.9 Recorded data must be signed (by the person who recorded the data) and dated on the day that the data is recorded.

6.5.10 Do not attempt to alter or correct another individual’s work. Only the personnel making the original entry can correct that entry.

In the case where personnel are not available to make a correction, a notation can be made by the personnel’s supervisor or management indicating the reason the person is unavailable to make the required correction.

6.5.11 Do not use signature pads, scanned signatures, or duplicated original signatures to replace a handwritten signature.

6.6 Abbreviations, Acronyms, and Symbols

6.6.1 Ensure any abbreviations, acronyms and symbols used in documentation are clear and standardized throughout the document for consistent interpretation. For each abbreviation, acronym, and symbol used, ensure:

It is spelled out or defined the first time it is used, or;

Use a glossary or table to explain it.

6.7 Recording Date and Time on BMC Documents

6.7.1 Record the date in the format day-month-year, DDMMMYYYY. For example, 16MAR2019.

6.7.2 Always record the date using:

Day – 2 numerals (DD)

Month – three-letter abbreviation, first 3 letters of month (MMM)

Year – 4 numerals (YYYY)

Example: 09OCT2014

6.7.3 When creating documents that require using numerals for the date, specify the format used (i.e., MM/DD/YYYY)

 6.7.4 Record time using 12 Hour Clock (Meridian Time) or 24-Hour Clock (military format) as follows:

12 Hour Clock	24 Hour Clock
11:59am or 11:59pm	11:59 or 23:59
12:00am or 12:00pm	00:00 or 12:00

 

6.8 Completing Blank Spaces, Error Corrections, Annotations and Footnotes

6.8.1 All fields on forms must be completed. Do not leave blank spaces on a document. Draw a single line through any space or section when there is no appropriate entry. Enter N/A, and initial and date.

If a field continues across a page break due to formatting (e.g. in Word, Excel, etc.) cross-off, N/A and initial and date both sections.

Note: Electronic databases may not allow N/A to be entered into a field due to field requirements (numeric data only) or the database may record the user information before a user electronically signs a record. In such cases, the database field requirements take precedence.

If blank lines are crossed out in error, enter data/information in another copy of the document and attach the two documents together as described in 6.3.3, or enter data/information in another page of the notebook and make reference to the new page. Alternatively, add a footnote and explain the error in the comments section, as applicable.

Do not write in the area that was crossed out and include an appropriate comment and initial and ate.

If a field is left blank and discovered at a later time, the individual originally completing the record lines out the field with their initials, current date and a brief explanation. A team member who is responsible for reviewing documents or the individual’s supervisor may also cross-off the field.

When permitted to be left blank, clearly identify the spaces or empty fields as “intentionally left blank”. Electronic databases may not allow this verbiage to be added. In such cases, system parameters take precedence.

6.8.2 To correct an error:

Draw a single, straight line through the length of the error

Make corrected entry near the original error

Record error code, as directed in Step 6.8.4

Record your initials and the current date

Error Correction Example with Error Correction Directives

Error Correction Example without Error Correction Directives:

01 May 2016 01 May 2018 WD JLC 01 May 2018

6.8.3 Do not obscure the original entry in any way (no white-out, over-writing, or multiple cross-outs).

6.8.4 If the reason for the correction is not obvious, include a note to explain why the correction was made. For more obvious corrections, such as calculation errors, below are examples of acceptable abbreviations that may be used:

Error Code	Definition
CE	Calculation Error
EE	Entry Error
LE	Late Entry① ①Document an explanation to substantiate the entry and the reason for the delay in recording.
SE	Spelling Error
WD	Wrong Date
TE	Transcription Error

 

6.8.5 If a correction is complex or needs further explanation requiring additional space, use a footnote near the original entry employing an alphanumeric format as shown below:

Starting with the number “1” or letter “a”, place the alphanumeric with a circle around it next to the error. (e.g. ^① or ^ⓐ)

Where there is space on the page, document the correction using referenced footnote, initial and date.

Note: Do Not use asterisks (*) for correction footnotes.

If multiple corrections are made on one page, use the next number as a footnote within the same page.

If the same correction is required to be made by the same person within the same page, use one footnote reference.

6.9 Memoranda and Appendices

6.9.1 When provided as supportive evidence to a quality record, the Author signs and dates memoranda and appendices and attaches them to the quality record.

6.9.2 Where memoranda or appendices are provided to a project or investigation, cross-reference to the corresponding activity file number (e.g. Investigation, Corrective and Preventative Action (CAPA) or Non-Conformance Report (NCR)).

Include enough information to clearly indicate the scope, timeframe, and/or other applicable bounding information in the Memoranda.

6.9.3 An email cannot be used as a “stand alone” quality record.

When an email is used as a supplement to a quality record, limit the content of the email to the immediate subject, with no additional subjects, attachments, or editorial content.

Include the associated reference number (e.g. CAPA) on the email and the Sender’s or Receiver’s signature and date (the signature may be either electronic in a validated system or on a hard copy with indelible ink).

6.10 GxP Document Retention

6.10.1 Retain GxP documentation with signatures according to BMC-SOP-04.

7.0 APPENDICES

7.1 Appendix A: Good Documentation Practices for SSF Collaborating Biobank Personnel

Page 1

Page 2

Page 3

Page 4

8.0 REVISION HISTORY

Revision No.	Section	Change Description/Justification	Date
0.0	N/A	New document outlining the process for good documentation practices.	Current

 

Document Number: BMC-SOP-20

Title: Internal Quality Audit

Revision: 1.0

Effective Date: 04 Nov 2024

Supersedes Date: First Issue

Author: Janet Price-Lutz 15 Oct 2024

Approver: Jenna York 15 Oct 2024

Approver: Robert Orr 21 Oct 2024

Quality Assurance: Jennifer Marsh 22 Oct 2024

1.0 PURPOSE

1.1 This purpose of this Standard Operating Procedure (SOP) is to define the internal audit process for the Biospecimen Management Core (BMC) area, which takes place on a planned basis over the course of a year.

2.0 SCOPE

2.1 This procedure is applicable to all BMC areas that have quality oversight.

3.0 ROLES & RESPONSIBILITIES

BMC Staff

• Receive audit plan
• Confirm dates of audit
• Provide documents
• Complete audit non-conformances
• Approve audit report
• Provide timely responses to audit findings

Quality Assurance (QA)

• Develop internal audit plan
• Conduct audit and complete audit report
• Provide audit report to management
• Following up on audit responses and action implementation

4.0 REFERENCES AND RELATED DOCUMENTS

• N/A International Society for Biological and Environmental Repositories (ISBER) Best Practices – current edition
• BMC-SOP-17 Documenting and Managing Corrective and Preventative Actions
• BMC-TMP-09 Internal Quality Audit Plan
• BMC-TMP-10 Internal Quality Audit Checklist
• BMC-TMP-11 Internal Quality Audit Report

5.0 DEFINITION OF TERMS

• Corrective Action Preventative Action (CAPA) – Improvements to a process taken to eliminate or reduce non-conformances or other undesirable outcomes.
• Internal Audit Plan – An approved document describing the specific audits to be conducted by QA quarterly for a given year. The plan includes the scope, rationale for the scope, and the planned timing for each audit.
• Internal Quality Audit – An independent examination and evaluation of the quality system requirements through assessment of personnel, procedures, processes, and/or products, by individual(s) independent of the function being reviewed. Audits are performed to provide an assessment of a system’s internal controls.
• Non-Conformance – An unexpected condition or event in which any characteristics do not conform to specifications required and/or stated. This may include failures, deficiencies, defects, deviations, and malfunctions.
• Observations – A potential issue that could lead to a non-conformance. This could be considered an opportunity for improvement and does not require immediate corrective action.

6.0 PROCEDURE

6.1 Overview

6.1.1 QA is responsible for planning and implementation of internal quality audits.

6.1.1.1 Creates the internal audit plan.

6.1.1.2 Conducts the audit and completes the audit reports.

6.1.1.3 Reports audit results to management.

6.1.1.4 Performs follow-ups on audit responses and action implementation.

6.2 Internal Audit Plan

6.2.1 QA will determine which processes will be audited for a particular quarter. A schedule will be created (see BMC-TMP-09).

6.2.1.1Three to four processes and associated procedures will be audited per quarter.

6.2.1.2 Other means for inclusion into the audit plan is as follows:

Changes to a procedure or process

Known deviations

Outstanding corrective actions

Request by management

Follow-up from prior audit

6.2.2 QA will complete Internal Audit Checklist, BMC-TMP-10 for procedures being audited.

6.2.3 QA develops Internal Audit Plan based on input from the checklist.

6.2.4 BMC management and QA review and approve the audit plan.

6.3 Conducting an Audit

6.3.1 Based on the system/equipment being audited, QA will determine which documents will be needed to perform the audit and identify the specific documents.

6.3.2 A minimum of three examples of each document will be provided to ensure that a representative sample is obtained.

6.3.3 Two weeks prior to initiation of an audit, a detailed list of documents needed will be requested by QA.

6.3.4 QA reviews documentation related to the audit scope including procedures, records, prior audit results, deviations, and other relevant documentation.

6.3.5 QA observes processes and relevant area activities as appropriate.

6.3.6 QA identifies observations and non-conformances during the audit.

6.3.7 QA uses audit ratings as a means to quantify the audit observations per the following table:

Classification	Definition
Critical	A serious deficiency with company standards, procedures, and/or current regulatory requirements or expectations that will provide an immediate and significant risk to product quality, patient safety or data integrity.
Major	A serious deficiency with company standards, procedures, and/or current regulatory requirements or expectations that will potentially provide an immediate and significant risk to product quality, patient safety or data integrity.
Minor	One that does not meet the criteria for classification of major or critical but is a departure from best practices and requires action(s) to improve the quality and/or efficiency of the systems used.
Recommendations/Comments	Suggestions given on how to improve systems or procedures that may be compliant at this time but if left unattended may become a compliance issue.

 

6.3.8 Assessments of non-conformances should be supported by at least one example of objective evidence.

6.3.9 Recommendations for performance improvement may be included.

6.4 Audit Reporting

6.4.1 QA prepares a detailed written Internal Audit Report, BMC-TMP-11, of audit observations upon completion of an audit.

6.4.2 QA shares reports with BMC management.

6.4.3 QA discusses audit observations with BMC management to ensure agreement.

6.5 Audit Response

6.5.1 BMC management responds to assessments of non-conformances. The proposed audit response may be developed with or without the collaboration of QA.

6.5.2 BMC management documents the response and submits to QA by the requested date. The final audit response must be reviewed and acknowledged by the BMC Director.

6.5.3 If the response cannot be provided by the request date, a mutually agreeable timeline for completion for the response is determined and documented.

6.5.4 Once received, the auditor reviews the response provided and determines the acceptability of the response. If the response is not acceptable, QA notifies management. If needed, a meeting is arranged to resolve any outstanding items.

6.5.5 Once a mutually agreeable response has been received, the audit is considered to be closed.

6.6 Audit Follow-up

6.6.1 An audit follow-up may be initiated at the discretion of QA in response to any of the following:

Serious non-compliance issues

Non-conformances requiring an extended period for resolution

Instances of recurring non-conformances

BMC Management request

7.0 APPENDICES

7.1 Not applicable

8.0 REVISION HISTORY

Revision No.	Section	Change Description/Justification	Date
1.0	All sections	Internal audit was a part of SF-1-08 (Quality Oversight) SOP. It will now be a separate SOP. SF-1-08 will be retired.	03 Oct 2024 See D-23-08