SOP SF SOP for Controlled Document Management

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2 SOP SF SOP for Controlled Document Management Page 2 of 13 freezer RQs has been revised to reflect retention guidelines for freezer alarm testing worksheets Procedure for retaining Freezer intake records, further defined to include Storage Agreements / Storage Requests and attached correspondence, was expanded to include further instruction and revised for retention guidelines in steps and Per step , Controlled Access Operations Documentation retention guidelines further defined in steps For clarification purposes, defined in step that facility commissioning and validation plans are retained indefinitely Deviation report, audit records, and OOS report retention was revised to indefinitely in step On-site retention of the same is specified in step Billing records retention is defined in step Appendix E updated to reflect all applicable revisions Added step to reflect that SSF personnel must ensure electronic versions of SOPs are stored on the SSF shared drive before destroying obsolete SOPs per retention guidelines defined in SF Revised Specimen-Specific Records retention guidelines in steps Appendix E updated accordingly Updated Section 6.2, Table Section 3 to define when N/A should be entered in the For Technical Processes Select Revalidation Requirements: section of the CCF Added further detail to Archive Procedure process steps Further defined Permanent Archive Removal process in steps and added Permanent Archive Removal Template (Appendix F) Added Interim Archive Storage (Off-Site) Procedure, defined in section 6.3.5, and added Interim Archive (Off-Site) Storage Log Template (Appendix G) Added to References Section 7, IU SOP for Research Involving Human Subjects and GRM Information Management Services contact information and SSF account number Revised Appendix D to reflect that SF-2-4, Appendix F should also be updated when SF-3-16 has been revised Updated Appendix D to reflect that Box has replace Alfresco for cloud document storage. 2. PURPOSE 2.1. This Standard Operating Procedure (SOP) defines the procedures used in the Indiana CTSI Specimen Storage Facility (SSF) for managing controlled documents. This procedure satisfies guidance set forth in ISBER Best Practices specifically addressing Records Management guidance in Sections G1.000 through G PRINCIPLE 3.1. ISBER Best Practices requires that each repository should develop and maintain a records management system that permits detailed records to be made concurrently with the performance of each step in the collection, processing and distribution of specimens. Records must allow traceability of specimens and conditions that may affect specimens, have limited accessibility on a need to know basis, and must be retrievable. Demonstration of specimen traceability is limited to those specimens which are managed by the SSF. Documents must have a defined

3 Page 3 of 13 effective date, system for assuring that the current effective document is readily available and used, and a system for change control. Distribution of samples by the SSF is limited to the release of specimens to investigator-specified personnel upon request of the investigator Archived document storage must define location, length of time records must be stored, and security and access restrictions for the archived documents. Retention periods from the SOP text are summarized in Appendix E for reference only Records must be readily accessible for inspection by authorized personnel from regulatory agencies and applicable biorepository personnel. 4. SCOPE 4.1. This SOP defines the actions and responsibilities for all SSF personnel as related to critical document control and management following the applicable document approval process. Specifically it addresses training records, SOPs, equipment and facility maintenance, audit and review results, specimen storage locations and conditions, and quality compliance activities Documentation of specimen traceability for samples not managed by the SSF is excluded from the scope of this SOP Quality Assurance is responsible for administration of the document control process. 5. MATERIALS 5.1. Waterproof/Fireproof file cabinet(s) 6. PROCEDURE 6.1. Document Management Master Guidance After signatory approvals are documented, final versions of the documents and change control forms are forwarded to QA (or QA designee) for document control purposes. The approved hardcopy and electronic copy are the official documents to be used for read/understand training and for implementation. The electronic copy may be used for client use and review as directed by CTSI SSF Oversight Committee / Management directives Documents are retained in document manuals to facilitate review by SSF personnel. Documents may be moved to archive prior to the time periods stated below without consequence Document management practices defined in another SOP specific to the documents managed by that SOP supersede the document management practices defined in this SOP Electronic documents are maintained on one or more servers maintained by IUPUI Information Systems personnel. Files may be maintained in one or more formats and an example of a suitable system is described below Microsoft Word files are saved as password protected documents for the purpose of convenient electronic revision. These files have read/write access assigned by SSF management PDF files of scanned signature versions of SOPs are maintained for convenient electronic review by all authorized SSF personnel Microsoft Excel files may be used to generate an updated Table of Contents for each SOP Manual. Contemporaneous revisions to the Table of Contents are performed by the individual performing the SOP SF SOP for Controlled Document Management

4 Page 4 of 13 document control function (or designee) of the hard copy documents into and out of the SOP manuals The electronic copies of approved SOPs are maintained separately from obsolete versions to prevent inadvertent use Electronic document control (movement into and out of approved status) is performed contemporaneously by the individual performing the document control function (or designee) of the hard copy documents into and out of the SOP manuals A checklist is provided in Appendix D to assist the individual performing the document control function. This form is considered to be a template and suggested tool only and therefore, completion of the form is not controlled SOPs Issuance: Original and revised SOPs are issued as described in SOP SF-1-1: SOP for Writing Reviewing and Approving SOPs Identification of Originals/Copies/Obsolete versions The approved hardcopy version of a document with the original signature is the official document and is managed by the Facility Manager Signature of QA or QA designee need not be an original for approval. (i.e electronic approval is acceptable until the original documented signature is provided.) Official Copies of Documents include those copies stamped denoting them as official copy on the first page with identifying initial and date by authorized SSF management or QA. The SOP text portion of the documents are intended to be maintained intact. Copying (or printing) portions of the SOP for use in implementation is prohibited. Posting of any portion of an SOP (including an Appendix) is prohibited unless the document is recognized as an official template as described in step and listed on the Table of Contents as an official Posting In very limited cases, unofficial copies may be provided during active technical training or client/visitor information and must be stamped Unofficial Copy. If a document is not stamped and signified as noted in step , it is, by default, an unofficial copy. Unofficial copies are not maintained by the document control system An SOP is rendered obsolete when retired or replaced by a revised document and is noted accordingly on page 1 of the document by QA or SSF Management Revisions are controlled via the Change Control Form (Appendix C) Complete change control form as defined in Section QA or SSF Management will attach the completed change control form to the applicable revised or retired document The Change control form is attached to the obsolete SOP and retained as defined below. SOP SF SOP for Controlled Document Management

5 Page 5 of Retirement/Archive: When an SOP is obsolete, the original SOP is moved to the SSF Archive and managed per Section 6.3 of this SOP. Copies of SOPs are removed from their respective manuals and are destroyed. Destruction need not be documented. Retention of documents in archive is 5 years total unless otherwise defined Original SOPs are retained in the SSF Operations Management Office Official Copies of SOPs are located in the associated work areas A template for an SOP Table of Contents is provided in Appendix A. The electronic version of the Table of Contents (described in step ) is printed and placed in each SOP manual to detail the specific SOP list (along with the respective version number and effective date) contained in the respective SOP manual. Obsolete versions of the Table of Contents need not be retained Forms: Forms are documents designed to record a defined set of information and are associated with SOPs and version controlled as defined in SOP SF-1-1: SOP for Writing Reviewing and Approving SOPs Issuance: Original and revised forms are issued as described in SOP SF-1-1: SOP for Writing Reviewing and Approving SOPs Identification of Originals/Copies/Obsolete versions Identification of original forms, official copies of forms and obsolete forms is not applicable since forms are appendices to SOPs which are identified as described in section The only exception pertains to a form which has been revised in hard-copy form and contains handwritten changes and/or effective dates. In this case, the original document is considered to be the one with the original handwritten entries and copies are then made from this original. This document is kept in the SSF Operations Office Copies of forms are not controlled as official copies however; care must be taken to assure that only current versions of forms are available. Generation of extraneous copies of forms is not permitted For convenience, a copy of the current version of all forms is maintained in a Form Logbook at the SSF technician desk in C158. SSF Facility Manager places revised forms and removes obsolete form versions from the form log as appropriate. As needed, forms can be removed from the form logbook to generate the minimum number of necessary copies and then returned to the book once copies have been made SSF personnel are responsible for ensuring that all copies of obsolete forms are destroyed to prevent inadvertent use. Destruction need not be documented A form is rendered obsolete when retired or replaced by a revised form version Form revisions may occur concurrently with an SOP revision or independently from an SOP revision. Revisions of both types are controlled via the Change Control Form (Appendix C) Complete change control form as defined in Section 6.2. SOP SF SOP for Controlled Document Management

6 Page 6 of QA or SSF Management will attach the completed change control form to the applicable revised or retired document The Change control form is filed with the obsolete SOP if the form is revised concurrently. If a form is revised independently from an SOP, the change control form is attached directly to the obsolete form version and retained as defined below Retirement/Archive: When a form version is obsolete, it is moved to the SSF Archive and managed per Section 6.3 of this SOP. Retention is 5 years total unless otherwise defined NOTE: Monthly equipment log form modifications as described in SOP SF-1-1: SOP for Writing, Reviewing and Approving SOPs need not comply with the requirements described in this section Templates are essentially blank forms defining only the format of the content and not the content itself. Note: the Table of Contents (Format defined in Appendix A) need not comply with the requirements in this section Should the format of a template require revision, changes are controlled as defined in step The content within a template may be changed by SSF Management or QA as required for effective operation of the SSF. Content changes in templates do not require completion of a change control form Effective dates are assigned at the time the content is applicable Obsolete dates are assigned when the content is updated by a revision to the template content There must be no date overlap or time gaps in consecutive content versions for a given template Obsolete versions of templates are maintained in the archives as defined in Section 6.3 below. Retention is 5 years total unless otherwise defined Postings are appendices to SOPs (either forms or templates) which are posted in defined locations throughout the SSF for frequent and direct access. It is imperative that the current version of these documents is available for SSF personnel at all times A Table of contents is used to readily identify the document title, version ID, effective date and defined location of all posted documents. A template for the Table of Contents is provided in Appendix A Control of postings (including updating the Table of Contents and placement of all documents posted) is performed contemporaneously by the individual performing the document control function (or designee) of the hard copy documents into and out of the SOP manuals. Obsolete versions of the Table of Contents and the obsolete postings need not be retained. Destruction need not be documented Facility/Equipment Monitoring & Maintenance records Current monitoring and maintenance records are maintained in the area of the applicable equipment or facility being monitored Recent records are maintained in the SSF Operations Office SOP SF SOP for Controlled Document Management

7 Page 7 of Long-term records are maintained per Section 6.3 of this SOP as described below: SSF-owned non-freezer equipment (maintenance, repair and monitoring logs): Minimum of 3 years Freezer equipment (maintenance, repair, and monitoring logs) Minimum of 7 years or 3 years after study closure, whichever is longer Alarm System Management and Response Retain indefinitely, with the following exceptions: Alarm Logs Hard Copies: Minimum 5 years Electronic Versions: Retained indefinitely, backed up onto shared drive System activity reports (including alarm activity) are automatically downloaded from the Siemens Alarm system daily, stored in C:\Insight\Reports on the Siemens alarm computer, and should be retained indefinitely SSF Alarm Call Personnel Log (Template) Minimum 3 years SSF Siemens Alarm Response Guide Minimum 3 years Siemens Alarm Console Administrators Minimum 3 years Alarm System Daily Maintenance Log Minimum 5 years APOGEE Insight Services Startup Parameters Daily Verification Minimum 3 years Facility-related maintenance documents retained indefinitely, with the following exceptions: MRU Storage Room SOP, SF MRU Room Maintenance Log Form: Minimum of 3 years LN2 System and Freezer Room Operations SOP, SF LN2 System Daily LN2 Usage Log Minimum of 3 years LN2 System Maintenance Log: Quarterly and Annual Assessments Minimum of 3 years LN2 Expected Use Range Calculation Form Minimum of 3 years, with digital versions kept indefinitely SOP SF SOP for Controlled Document Management

8 Page 8 of LN2 Systems Post-Fill Observation Log Minimum of 3 years Low O2 Alarm Actions and Response / Emergency Contacts and Actions Minimum of 2 years LN2 Weekly System Check Minimum of 3 years Freezer (LN2 and MRU) Alarm Testing Worksheets Minimum of 7 years or 3 years after study closure, whichever is longer Freezer intake records and supporting documents (Storage Agreements / Storage Requests and attached correspondence; GLP or otherwise) duration of unit retention in SSF plus an additional 7 years (minimum) Closed SSF Accounts for which the freezer is still stored in the SSF Minimum of 3 years, with paperwork indicating account transferred stored with new account (May be retained electronically. If electronically stored, records are to be scanned and stored in a limited access shared folder within the CTSIProcessingLabs folder Controlled Access Operations Personnel Controlled Access Activation/Deactivation Records Minimum of 2 years Visitor Logs Minimum 3 years Access Review Report Checklists (Monthly & Annual) Minimum of 5 years, with the following exceptions: Critical access records prior to March 2011 were not digitized and are to be retained indefinitely Digital versions of access logs, stored in a limited access shared folder within the CTSIProcessingLabs folder, are to be retained indefinitely Annex II Key Log Minimum 2 years Door Held/Forced Door/Point Active Event Log Minimum 5 years Facility Commissioning and Validation Plans are retained indefinitely Training Records Current training records are maintained by the employee Recent completed records are maintained in the SSF Operations Office Long-term records for current employees are maintained per Steps of this SOP for the length of their employment in a position with SSF access plus SOP SF SOP for Controlled Document Management

9 Page 9 of 13 a minimum of 3 years. 3 years of records must be maintained on-site, while older records may be shipped off-site for storage space considerations per Step of this SOP Long-term records for employees for whom SSF access had been rescinded are retained in the on-site archive for a minimum of 3 years and then discarded per Step of this SOP Deviation Reports, Audit Records and Out-of-specification (OOS) Reports - At the end of each calendar year, closed deviation reports, closed OOS reports and audit records approximately months old are moved to the archive and retained indefinitely Obsolete SOPs, Templates, and Memos-to-File current and long-term documents are retained in the SSF Operations office for a minimum of 5 years after the obsolete date (or approval date for Memos-to-file) SSF Personnel must ensure that an electronic version of the obsolete SOP is stored on the SSF shared drive before destruction Specimen-Specific Records Sample-specific documentation for which there was active, on-going processing, release or storage (to include sample receipt documentation, sample processing documentation and sample release documentation) is maintained in the SSF area nearest in proximity to the activity being performed (receipt, processing, release) Long-term sample processing and release records are maintained per Section 6.3 of this SOP for the duration of sample retention for each collection plus an additional 7 years or 3 years after study closure, whichever is longer Sample-specific documentation, as defined in step , for samples leaving the SSF prior to this retention period may be released to Study personnel Release documentation is signed by SSF and Study personnel Release of records is managed per section of this SOP Sample receipt (Intake) records are maintained indefinitely years minimum are to be retained in the SSF Operations Office per Section 6.3 of this SOP Billing Records Though not an SOP-defined procedure, billing records are to be retained a minimum of 12 years from the billing date per the CTSI Financial Officer Completion of the Change control Form (Appendix C): A document revision may be initiated by any member of the SSF and the person initiating the revision must obtain and initiate a Change Control Form at the time of initiation of the review for possible revision or retirement. The table below defines the required content, the order of completion and the responsibility for completion of the change control form. SOP SF SOP for Controlled Document Management

10 Section Description Sequence/Timing 1 Document the following information as defined below: Document # - The number assigned the version currently in effect Title The title of the document to be revised. Review initiated by Name of person initiating the review for document change. Initiation Date Date of initiation of the Change Control form. Purpose of the Review Request: This may be for defined periodic review as defined in the applicable SOP, a change in the procedure, required clarification, etc. Complete at the time a document is discovered to need review for possible revision or retirement. Page 10 of 13 Responsible Party Person initiating the review. Requested completion Date: If for routine periodic review, enter the date as the effective date plus the SOP-defined mandatory review interval. For other reviews, define the date based on the document approval requirements for the respective SOP. 2 The Determination of action is made by and the section completed by the person initiating the review for possible revision or retirement Complete after the document has been reviewed for consideration of a revision or retirement. Person initiating the review. If the determination in Section 2 is Acceptable note this section as N/A. Otherwise, proceed as defined below: Reasons for Revisions: Enter a numbered list of items to be revised. For each item include Section, current content, new content, and rationale for the content change. Ensure that revised appendices are individually identified, as applicable. Describe Training/Re-training requirements: Consider and record the type of training required and indicate applicability with regard to all personnel technical personnel, etc as appropriate: 3 No training required (only if insignificant typographical changes are incorporated) Read-Only training required Technical Training required For Technical Processes Select Revalidation Requirements: Consider the following for revalidation taking into account SOP SF-1-12 (Facility Commissioning and Validation/Revalidation) as well as procedures, equipment, reagents, and quality measures in this determination. If the document being revised does not pertain to the HVAC, LN2, or Alarm System, or the Facility (Building), note this section as N/A. Signature/Date: (SSF Management member completing this section) Complete after: 1. Review is complete by all applicable parties. 2. A draft version of the revised document (if applicable) has been circulated for review 3. The consensus revised document is ready for signature. SSF Management SOP SF SOP for Controlled Document Management

11 Page 11 of 13 4 If the determination in Section 2 is Acceptable note this section as N/A. Reasons for Retirement: If retired, an overarching statement describing the reason for retirement and any subsequent document that may be replacing this document as applicable. Signature/Date: (SSF Management member completing this section) Complete after: 1. Review is complete by all applicable parties. 2. A consensus for retiring the document is reached. SSF Management 5 Documentation of Approval/Disapproval; Each signatory on the original document (if available) and new document notes approval/disapproval, comments and initials and date of approval/disapproval. When the replacement document (if required) is in final draft version or consensus is reached for retirement. Each signatory on the original document (if available) and new document (if applicable) Archive Procedure Fire-proof cabinets for archival are located in the SSF Facility Manager s Office Documents leaving archive are logged in and out on the Archive Sign-out Log (Appendix B), stored in the Document Control binder located in the SSF Facility Manager s Office In lieu of itemizing on Appendix B, a printed itemized manifest detailing each document removed from archives may be attached Archive Retention is defined in previous section (steps ) Permanent Archive Removal When the archive retention period has expired, documents can be permanently removed from the archive files, if authorized by QA Following the retention period, specimen-specific documents are provided to the Study PI, if requested Information regarding document destruction is recorded on the archive sign-out sheet (Appendix B) by the archivist and is retained indefinitely In lieu of itemizing on Appendix B, a printed manifest detailing each document removed from archives may be attached, per Permanent Archive Removal Template, Appendix F Prior to permanent archive removal, the archive sign-out log and each document must be verified by SSF Personnel for required retention period and data entry accuracy (100% check). Performance of the verification is documented by technician by initialing and dating a printed version of Appendix F A second SSF personnel completes a 10% check of the 100% verification for retention period and accuracy of documentation. Performance of the verification is documented by technician by initialing and dating a printed version of Appendix F Prior to document destruction, QA Personnel MUST verify and approve permanent archive removal QA approval is documented on or attached to Appendix B. SOP SF SOP for Controlled Document Management

12 Page 12 of Interim Archive Storage (Off-Site) If storage space in the fireproof cabinets is needed, documents may be moved off site for intermediate storage prior to destruction. On-site retention of 3 years minimum is required for all documents with the following exceptions: Facility Qualification documents (CVMP, I/O-Q, RQ, URS) - retain on-site indefinitely Deviation Reports, Audit Records and Out-of-specification (OOS) Reports on-site retention of 5 years minimum Off-site storage is managed by the IU-approved vendor. Documents may be stored off-site at GRM Document Management (GRM), in compliance with the IU SOP for Research Involving Human Subjects, Security of Research Data (Long-term Storage) and Data Management (Retention) Sections AND if authorized by QA. Sending Archive Documents to Off-Site Storage Standard letter-paper width bankers boxes are accepted by GRM and may be purchased from GRM or via the IUPUI Purchasing standard channel for purchasing of office supplies Each box is barcoded with Barcode labels purchased from GRM and labeled with a brief description of contents per the Off-Site Storage Log. Each box may also be numbered sequentially for ease of reference and organization on the Off-Site Storage Log A detailed list of documents relocating to off-site storage is recorded by the archivist on the Off-Site Storage Log Template, Appendix G The Off-Site Storage Log is stored digitally in a limited access shared folder within the CTSIProcessingLabs folder A current printout is stored in the Document Control binder located in the SSF Facility Manager Office The content of boxes planned for archive is itemized on the archive sign-out sheet (Appendix B) by the archivist, with a detailed list of box contents for the current shipment attached Both Appendix B and Appendix G are retained indefinitely Prior to off-site storage relocation, the Off-Site Storage Log and archive sign-out log must be 100% verified by SSF Personnel for data entry accuracy. Performance of the verification is documented by technician by initialing and dating a printed version of Appendix G A second SSF personnel completes a 10% check of the 100% verification for accuracy of documentation. Performance of the verification is documented by technician by initialing and dating a printed version of Appendix G Prior to document relocation, QA Personnel must verify and approve off-site document relocation, with approval documented on or attached to Appendix B. SOP SF SOP for Controlled Document Management

13 Page 13 of Upon receiving QA approval, request the GRM pickup new boxes via phone call or online via EAccess. SSF GRM account number will be required EAccess account access, utilizing a user ID and password, will be set up through GRM Request delivery of boxes already stored at GRM via phone call or online via EAccess. SSF GRM account number and barcode of each box will be required Request return of boxes previously stored at GRM via phone call or online via EAccess. SSF GRM account number and barcode of each box will be required. Re-approval/re-verification is not required for the return of these boxes. 7. REFERENCES 7.1. ISBER Best Practices (Current Version) 7.2. IU SOP for Research Involving Human Subjects (Current Version) 7.3. GRM Information Management Services SSF GRM Account Number, Web: EAccess online requests: eaccess.grmdocument.com Phone: Address: 2002 S. East Street, Indianapolis, IN DOCUMENTATION 8.1. Deviations are managed per the SF-1-9 Deviation Management SOP. 9. APPENDICES 9.1. The current version of each of the following appendices is used to implement this SOP: APPENDI A: Table of Contents Template (1 Page) APPENDI B: Archive Sign-out Log (1 Page) APPENDI C: SSF Document Change Control Form (1 Page) APPENDI D: Document Control Checklist Suggested Tool Template (2 Pages) APPENDI E: Retention Guidelines (2 Pages) APPENDI F: Permanent Archive Removal Template (1 Page) APPENDI G: Interim Archive (Off-Site) Storage Log Template (1 Page) SOP SF SOP for Controlled Document Management

14 Appendix A SOP Master and Working Document Manuals (Template) Page 1 of 1 Document Title (ie. SOP, Posting, etc) Version Effective Date Document Title (ie. SOP, Posting, etc) Version Effective Date Document Title (ie. SOP, Posting, etc) Version Effective Date Document Title (ie. SOP, Posting, etc) Version Effective Date Master Location Location Location Master Location Location Location Master Location Location Location Master Location Location Location SF-1-6 SOP for Controlled Document Management Form version 02

15 Appendix B Archive Sign-out Log Page 1 of 1 Requestor Name Document Title & Number Date Removed Removed by Returned by Date Returned Received by Requestor Name Document Title & Number Date Removed Removed by Returned by Date Returned Received by Requestor Name Document Title & Number Date Removed Removed by Returned by Date Returned Received by SF-1-6 SOP for Controlled Document Management Form version 02

16 Appendix C: SSF Document Change Control Form Page 1 of 1 Section 1 Document # (Version currently in effect) : Title: Review Initiated By: Initiation Date: Purpose of Review Request: Defined Periodic Review / Requested completion date (If SOP, effective date + 2 years): Procedure Modification: /Requested completion date: 2. Determination: Document is acceptable - No revision required Change to Appendix Only (list & describe in section 3) Document requires revision (describe in section 3) Document requires retirement (describe in section 4) 3 Reasons for Revision: (List & describe any section numbers to be revised, continuing on reverse as needed) 3.1 Describe Training/Re-training requirements (as applicable): 3.2 For Technical Processes - Select the Re-validation requirements (if any): Re-validation of this SOP is Required None - No technical process changes were incorporated in the revised SOP None - (describe): Signature: Date: 4. Reasons for Retirement (List rationale and new Document # & Title as applicable, continuing on reverse as needed) Signature: Date: 5. Documentation of Approval/Disapproval (and any comments) from each Reviewer: Note: Each Reviewer to initial & date after making an entry - Comment on reverse if necessary) Approve Disapprove Comments Reviewer Initials Date Approve Disapprove Comments Reviewer Initials Date Approve Disapprove Comments Reviewer Initials Date Approve Disapprove Comments Reviewer Initials Date Approve Disapprove Comments Reviewer Initials Date QA Receipt of Completed Form: Initial Date SF-1-6 SOP for Controlled Document Management Form version 02

17 Appendix D Page 1 of 2 Document Control Checklist Suggested Tool Checklist Item Master Document Location Location Location Location Save an electronic copy of the revised document in password-protected form and issue document with change control form for signature When all signatures are present, determine issue and effective date. Place electronic version in Approved folder and move previous electronic version to Archive folder. Make appropriate number of copies of each SOP for each applicable SOP Manual. Number of copies needed: Identify official copies with appropriate ID on cover sheet Place SOP copies in appropriate manuals and remove obsolete versions Identify each original obsolete SOP with the obsolete date File Change control form with obsolete SOP Destroy copies of obsolete SOPs (NOTE: RETAIN ORIGINAL DOCUMENT!!!) Save a scanned copy of the revised document in PDF form Update electronic Table of Contents and print. Make appropriate number of copies for all SOP manuals. Number of copies needed: Determine if appendices were revised. If so: Save a new electronic copy of the SOP (in the approved folder) containing the revised Appendix (and updated form version) remembering to leave the SOP version unchanged both in the SOP and in the file name. Move previous electronic SOP version to archive. Make a copy of each revised form and update form log and form postings in C199M. Remove and destroy all obsolete form versions. Number of copies needed: If applicable, request that CTSI HUB Support replace obsolete forms with current versions on Determine if any postings were revised. If so, update table of contents and replace obsolete postings with revised postings. Destroy copies of obsolete versions. Number of copies needed: Determine if any templates were revised. If so, assign obsolete date to retired document and place in archive. Assign effective date to current versions and maintain in appropriate log. If SOPs SF-2-1, SF-2-2, SF-3-1, SF-3-2, or SF-3-16 were revised, update SF-2-4, Appendix F. SF-1-6 SOP for Controlled Document Management Form version 04

18 Appendix D Page 2 of 2 Checklist Item Master Document Location Location Location Location Replace obsolete pdf and Word documents on Box with current versions, archiving the obsolete documents. Request that CTSI HUB Support replace obsolete pdf SOP with current version on and confirm completion. Ensure SSF Management is aware of effective date for training purposes. Date of Notification: Other (describe) SF-1-6 SOP for Controlled Document Management Form version 04

19 Appendix E Page 1 of 2 Retention Guidelines SSF Document Description Duration of Retention (Years) SOP SF 1 6 Reference Alternate Reference 1 Obsolete SOPs Obsolete Form Versions Obsolete Templates SSF (Non Freezer) Equipment Monitoring & Maintenance Records Freezer Equipment Monitoring & Maintenance Records 7 or 3 years after study closure, whichever is longer Alarm System Management and Response, SOP SF 2 4, (with the following exceptions) Alarm Printouts (Hard copies) Alarm Logs (electronic) SSF Alarm Call Personnel Log (Template) SSF Siemens Alarm Response Guide Siemens Alarm Console Administrators Alarm System Daily Maintenance Log APOGEE Insight Services Startup Parameters Daily Verification Facility Related Documents (with the following exceptions) MRU Room Maintenance Log (SOP SF 2 1) LN 2 System Daily Usage Log (SOP SF 2 2) LN 2 System Maintenance Log Quarterly and Annual Assessments (SF 2 2) LN 2 Expected Use Calculation (SOP SF 2 2) Hard Copies LN 2 Expected Use Calculation (SOP SF 2 2) Digital Versions LN 2 Systems Post Fill Log (SOP SF 2 2) Low O 2 Alarm Actions/Response & Emergency Contacts (SOP SF 2 2) LN 2 Weekly System Check (SOP SF 2 2) Freezer (LN 2 and MRU) Alarm Testing Worksheets 24 Freezer Intake Records Duration of unit retention in SSF + additional years indicated in next column 7 or 3 years after study closure, whichever is longer 7 or 3 years after study closure, whichever is longer SF-1-6 SOP for Controlled Document Management Form version 02

20 Appendix E Page 2 of 2 SSF Document Description Duration of Retention (Years) SOP SF 1 6 Reference Alternate Reference 25 Closed SSF Freezer Accounts (freezer still stored in SSF) Paperwork indicating account transfer must be retained with current storage paperwork Facility Commissioning and Validation Plans Controlled Access (SF 2 3) 27 Personnel Activation/Deactivation Request Visitor Logs Access Review Report Checklists (Monthly and Annual) years indicated in next column, with the following exceptions Critical access records prior to March 2011 (hard copies) Digital versions of access logs Annex II Key Log Door Held/Forced Door/Point Active Log Training Records Current Employees Length of employment Training Records Former Employees Deviation Reports Audit Reports OOS Reports Obsolete Memos to File Specimen Specific Records Duration of Sample Retention + additional years indicated in next column 7 or 3 years after study closure, whichever is longer Sample Receipt (Intake) Records Billing Records SF-1-6 SOP for Controlled Document Management Form version 02

21 Appendix F Page 1 of 1 Permanent Archive Removal Template Item # Date Discarded Initials Category Document(s) Document Dates 1 Identifier 2 SOP Defined Retention period, per SF % Check Initials/Date 10% Check Initials/Date, as applicable 1 Controlled access date rescinded; Date samples removed from SSF; Maintenance logs year (and month, if partial year); Equipment retired date; Obsolete/retired date; Storage agreement date closed; OOS/deviation year 2 SSF account number; SSF/Collaborating biobank affiliation; Serial number; Equipment type; as applicable SF-1-6 SOP for Controlled Document Management Form version 01

22 Appendix G Page 1 of 1 Interim Archive (Off-Site) Storage Log Template SSF Box # Barcode Date Sent to GRM Contents 100% Check Initials/Date 10% Check Initials/Date, as applicable SF-1-6 SOP for Controlled Document Management Form version 01