Source: https://carl1anderson.wordpress.com/2010/07/25/part-11-how-will-fda-enforce/
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Enforce Part 11?
FDA’s announcement that it would begin inspections to enforce 21 CFR Part 11 has set of speculation on how FDA will enforce Part 11 and what they will be looking for. I’ve asked two experts, Len Grunbaum and Emma Barsky for their thoughts. They have written a Guest Commentary for the blog, one I am sure will be used as a resource by many of you concerned with Part 11 compliance. I first met Len at the last FDA training course I took, Advanced GLPs, where he was an instructor on validation. I learned a lot from him and think that he and Emma have a lot to share. Of course I welcome your comments and certainly would want to have additional Guest Commentaries on the subject.
The FDA announced on July 8, 2010 that it will be “… conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance….”
So … 13 years after promulgating the regulation and seven years after moderating their enforcement model – by exercising enforcement discretion regarding selected aspects of the regulation – the agency is still not comfortable about something. What can it be? While we cannot speak on the agency’s behalf, the words “in light of the enforcement discretion” imply to us that the agency is looking to 1) understand the disparate risk-based approaches taken by companies with respect to validation, audit trails, legacy systems, copies of records and record retention, and 2) determine how effective these approaches have been in establishing and maintaining data integrity (i.e., data completeness, accuracy and validity). Perhaps FDA will revise the regulation and/or issue new guidance that will reflect its ideas of what it perceives as the “best of breed” in terms of activities that most effectively and efficiently result in compliance with 21 CFR part 11. Who knows?
FDA Concern Regarding Data Integrity
We choose to focus our thoughts regarding this FDA’s initiative on data integrity because it is one of the main points that the FDA focuses on during its inspections. And it is because anything that calls data integrity into question will result in regulatory observations which, to date, have mainly been based on the predicate regulations that were put in place to promote data integrity. Therefore, enforcement discretion notwithstanding, we feel that companies will have to demonstrate the following basic quality measures to the agency:
1) All computerized systems that support regulated activities can be relied upon to operate as intended and identify all instances of incomplete, inaccurate and/or invalid data;
2) All regulated activities (e.g., changes to clinical data) can be reconstructed; and, 3) all regulated records (e.g., study data, manufacturing data) are available from the start of the respective process to the date of inspection and can be retrieved in a timely fashion. The way to do it would be to have complete, easy to follow and easy to explain documentation in support of the above-listed items; anything less may give the agency the perception that data integrity issues exist even if such may not be the case.
Listed below are some, but certainly not all, documentation pitfalls to avoid in this context:
The bottom line is that documentation must stand on its own. Given that FDA may look at processes and records from several years ago and that staff who implemented computerized applications may no longer be around, it becomes imperative that you do what you must to ensure that all of your documentation for computerized applications is such that it does not raise data integrity-related questions that cannot be addressed in a timely fashion.
This entry was posted on Sunday, July 25th, 2010 at 3:15 PM and is filed under Commentaries by Guest Writers.	You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.
Part 11: It’s Back « Carl's Blog on GxP Stuff says:
[…] Read the 25 July Guest Commentary on Part 11 by Len Grunbaum & Emma […]