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Electronic Records
(21 CFR Part 11)
Implementation Checklist

National Archives: NASA computers, Mercury project (ca 1952-1968)

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:__________________________________

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

Disclaimer
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).