Electronic Records 
(21 CFR Part 11)
Implementation Checklist

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The checklist below has been adapted from our reprint On Complying with 21 CFR Part 11. This article originally appeared in BioPharm Magazine in August 2000, with permission to reprint given by the publisher, Advanstar Communications.

Electronic Records (21 CFR Part 11) Implementation Checklist

FDA is in the process of revising the Part 11 regulation. Their current thinking about the rule, including their approach to enforcing the regulation, is defined in their guidance, Guidance for Industry: Part 11, Electronic Records, Electronic Signatures -- Scope and Application.  In January 2004, we were asked to write an article explaining the agency's new approach, as well as to provide practical tips on how to comply with the regulation, for Medical Device & Diagnostic Industry. That article, Part 11: New Guidance Provides Little Guidance, is available on line.

Three of our favorite Part 11 resources were published by the Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineers (ISPE). This Good Practice and Compliance for Electronic Records series has three volumes:

*  Part 1, Good Electronic Records Management
*  Part 2, Complying with 21 Part 11, Electronic Records and Electronic Signatures
*  Part 3, Models for Systems Implementation and Evolution

Although Part 1 was published before the agency began reconsidering its approach to Part 11, these guides contain useful information, and are highly recommended. They may be purchased online via the PDA bookstore.

The following checklist is not an all-inclusive list, nor is it the only approach to implementing Part 11. Your approach may vary.

  Information gathering
  Senior management informed; funding requested
  Company policy or consensus reached on interpretation of the electronic records rule
  Beginning a continual process of remaining current with Part 11 regulatory interpretation(s), inspectional findings, any new guidance documents, and new technologies
  Classes held for all employees
  • Information systems professionals and managers too

  Cross-functional team identified to implement rule
  • Excellent project leader assigned or identified
  • Routine meetings held; progress reports issued

  Project plan drafted with tasks and timetable
  Systems inventory completed
  Critical systems and records identified (those having greatest effect on product quality or those systems critical to 
manufacturing or laboratory operations, the product, or quality assurance)
  • Responsible individual identified for each system
  • Smaller teams organized for each system identified
  • Documents used to meet GXP requirements identified; determination made within the company whether the electronic version or the hard copy version of the document will be frequently referred to in-house; decision documented; employees trained on which version (electronic or hard copy) to refer to during their work

  Gap analysis of each system performed
  Necessary procedures and policies identified and implemented
  • Administrative SOPs or controls
  • How to provide electronic records to investigators
  • How to archive and maintain records and any necessary systems to read “old” data
  • Any new systems and/or software purchased are compliant (or as compliant as possible)

  Corrective action plan (remediation plan) and timetable approved to address any deficiencies
  • Corrections budgeted for next year
  • Corrections planned to be budgeted in future years

  Long-term corrective action identified, including systems that need to be replaced
  Systems validated and/or revalidated
  Corrective action plan completed; review performed; additional work (if any) identified; responsible individual assigned (with due date)
  Internal audits performed to assess or verify compliance; confirmation that employees are using the "official" version of the document only (whether electronic or hard copy); corrective action implemented, including training or retraining

  Other actions:__________________________________

Use Information
The information on this page is provided free-of-charge for downloading, photocopying, and using in your classes or department meetings.  The reprinting, transmission, or distribution for sale or use in a for-fee conference or course of this information is expressly prohibited.  If you download the material, please ensure that the following copyright statement appears prominently on the bottom of each page downloaded:

Copyright 2010, Immel Resources LLC, Petaluma, CA USA, (707) 778-7222, immel@immel.com.
Permission to reprint given by Immel Resources LLC.

This information is not all-inclusive nor is it intended to replace the advice of an experienced quality assurance or regulatory compliance professional.  Every organization manufacturing pharmaceutical, biological, and medical device products must meet at least the minimum, applicable current good manufacturing practices (CGMPs).

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