Part 11 Maintenance of Electronic Recs. Guidance

WITHDRAWN BY FDA Feb 2003 as not representative of their current thinking

FDA issued another 21 CFR Part 11 Draft Guidance: “Maintenance of Electronic Records”. Some may have previously referred to this as the archiving guidance. It is available at the link provided. The comment period ends Dec. 5, 2002.

This guidance first addresses basic requirements for maintaining the integrity of electronic records and signatures for the entire data retention period required in the predicate rules (Parts 820, 58, 211, etc.). Some of the topics discussed include items such retention of software, media replacement. It defines the need for procedures to address maintenance of records and discuss factors that could affect record reliability. It stresses that electronic records need to be accessible throughout the retention period not just based on frequency of usage and it mentions several times that the same types of filters, sorts, and reports should be possible throughout the time period.

It then discusses two types of approaches to records maintenance. The first is referred to as the “time capsule” approach where a system, software, and data are preserved exactly as used to create the records initially. In discussing the approach FDA expresses some doubt this approach would work long term given the rapid change in and fast obsolescence of technology and media.

The second approach is referred to as “records migration” in which records are moved from one computing environment to another. The discussion of this approach is lengthy and identifies many controls needed. One interesting statement is that an audit trail for a migrated electronic record should cover the “creation” of the new migrated record and not just that the migrated information must carry over the prior audit trail information. Another interesting area is FDA’s recognition and allowance for the fact that some data may by technical necessity change due to migration and the comments on what types of change might be acceptable if properly document.

Note that no where in the guidance does it allow for printing all the information to hard copy and retiring the electronic data and system.


Latest News!

Updated Risk Management training course now available.  Includes:

  • Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.  Contact

Corporate Office

15148 Springview St.
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN, TX) and Canada.