21 CFR Part 11 Assessment Project Summary

The Challenge

Performance Validation was contracted by a leading health care research laboratory to assess and document the FDA 21 CFR Part 11* compliance status of a proposed computerized laboratory optimization and compliance management system.  The laboratory was in early stages of Good Laboratory Practices (GLP) compliance remediation and this system and its compliance capabilities were a critical part of that goal.

The client was in the process of procuring a configurable (GAMP Level 4) Software as a Service (SAaS) system for their laboratory business.  The targeted software solution would provide the client with the tools to electronically manage their GLP work processes, including:

  • document management
  • training management (delivery and tracking)
  • SOP management
  • event management documentation

The client needed:

  • first, to understand the applicability of Part 11 to their proposed system
  • insight on what vendor software components would need to be implemented to satisfy Part 11 requirements
  • assistance in identifying any Part 11 compliance gaps that may exist in the software solution and/or its proposed implementation
  • advice on how to remediate any gaps found in the software solution and/or its proposed implementation

* 21 CFR Part 11 (Part 11) sets forth the criteria under which the Food and Drug Administration (FDA) permits electronic records and signatures in place of paper records and handwritten signatures.  See links below:

CFR – Code of Federal Regulations Title 21:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

 Guidance for the Industry Part 11, Electronic Records; Electronic Signatures – Scope and Application:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070295.pdf

The Results

Performance Validation provided a team of experienced GLP Computer System Validation professionals to develop an approach following ISPE’s GAMP 5.

21 CFR Part 11 Gap Analysis – The team interviewed Laboratory stakeholders and the software vendor to gather pertinent information needed to complete Gap Analysis to document the system’s compliance status in relation to the all requirements of Part 11.  The Gap Analysis checklist included considerations for:

  • Part 11 applicability
  • processes and procedures related to the use of electronic records and signatures
  • electronic record audit trails
  • logical security, user permissions, and workflow enforcement
  • documented procedures and training for personal involved in operation and maintenance of the system
  • implementation of electronic signatures

21 CFR Part 11 Summary – The team provided the client with a working document that:

  • summarized the findings of the 21 CFR Part 11 Gap Analysis
  • identified the Part 11 compliance gaps that would require remediation
  • provided the client with the list of corrective actions to be completed in order to resolve the compliance gaps

In this client’s case, the system was determined to be an “Open System” that employed the use of electronic records and signatures.  Vendor provided software solution was assessed and no gaps were found with it.  However, other Part 11 compliance gaps were found associated with the client’s Quality System documentation and procedures.  These gaps were mitigated through client procedural controls (SOP).

The Benefits

The client laboratory was provided with:

  • time and resource efficient communication methods (i.e. web conferences, phone calls, emails) used in information gathering and exchange processes, minimizing impact to client project costs and work schedules
  • a clearly defined list of corrective actions to be completed in order to address each of the identified gaps in the system’s 21 CFR Part 11 compliant status
  • guidance on how to address the corrective actions
  • a facilitated review of the final draft documents by appropriate stakeholders to address questions prior to sign-off
  • a detailed summary explanation of the 21 CFR Part 11 Gap Analysis and 21 CFR Part 11 Summaryto the committee of interested parties to ensure each necessary gap could be addressed prior to system testing and implementation

The PV Advantage

  • The Performance Validation team on this project had vital experience in GLP laboratory compliance which contributed to an efficient and comprehensive 21 CFR Part 11 compliance assessment.  PV understood the regulations, the FDA Guidance, and the preamble requirements.  The preamble provided industry and FDA insight that went into the adoption of the regulation.
  • The team maintained document transparency and clarity, critical to delivering documentation that stands up to audits by regulatory bodies such as the FDA.
  • The team met its professional goal to provide the laboratory client peace of mind by taking the Part 11 ruling and breaking it down into manageable pieces for clear and concise evaluation.

The client’s needs were met through

  • collaboration with the software vendor and the laboratory stakeholders
  • excellent documentation practices
  • expert knowledge of industry standard practices.

For More Information, Contact:

Kevin Marcial,
Senior Validation Engineer
Performance Validation, LLC.
5168 Sprinkle Road
Portage, MI 49002
(269) 267-4020 Mobile