FDA's Electronic Record Review Enforcement Policies Present Challenges

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Patrick Stone, President, TradeStone QA

In 1999 the FDA released guidance for industry on the electronic records requirements for human clinical trials involving drugs, devices & biological entities (including the manufacturing of the approved products previously listed). In 2002 the FDA started training the field investigators how to review electronic records during routine inspections of human bioresearch and manufacturing for drugs, devices & biological entities. The catch was FDA investigators were not able to actually cite violations for 21 CFR Part 11 (code of Federal regulations) until approximately 2006.

The FDA instructed field investigators to only write up 21 CFR Part 11 violations if there were other non-Part 11 violations as well. One of the reasons it took so long to enforce the 21 CFR Part 11 violations was that fact that TurboEIR (FDAs report writing template system) did not have 21 CFR Part 11 483 cites. TurboEIR 483 citations became standardized because of the inconsistencies of 483s issued throughout the nation.

Fast forward to 2009 and the FDA starts to ramp up electronic record review for every firm that uses electronic records.

As an FDA investigator I have conducted many electronic record reviews and discussed many 483 cited observations with the Center for Drug Evaluation & Research and the Center for Devices and Radiological Health.

The most recent inspection I conducted for electronic records was a molecular diagnostic laboratory conducting testing for human clinical trials. This was a very special case in which I observed the clinical trial data did not match the data-listing provided by the sponsor. Long story short, the firm was using a data-stick to transfer original data-output and transferring it to an Excel data-set. Microsoft Excel® is not 21 CFR Part 11 compliant and the Excel® program cut off too many digits after the decimal place. The solution was an easy fix in that I suggested the molecular lab simply print out the original data and use that instead of the data-stick transferred data.

The Center put a short hold on the project until the reems of paper could be submitted in proper fashion.

The moral of the story is that as a sponsor or health care manufacturer you have to ensure that any projects slated for all electronic record submissions must be qualified and verified to comply with the electronic record regulation.

I will also give you one more example of a scenario where a project was held up by the agency for electronic record issues. I was inspecting a human clinical drug trial and I observed that source data did not match the sponsor provided data-listing because when the study was closed out and the data-lock was put in place it changed the audit trials and greyed out many data-points.

When choosing an electronic records vendor make sure that the data is never obscured or unreadable when the clinical trial is completed and data-lock is in place. You have to go from cradle to grave with your data and validate every step.

The FDA has made numerous electronic records exemptions for the Department of Defense and other U.S. Government agencies under the following exemption law (device products). A Compilation of Exemptions for Electronic Products Found in 21 CFR Chapter I, Sub-Chapter J — Radiological Health Parts 1000 – 1050.

However, the FDA does not currently abide by the electronic records regulation it enforces, for another case of do what I say, not what I do.

You can follow Patrick on Twitter: http://twitter.com/BIMOQA

Showing 2 comments
  • Reply

    In your post you speak abou the implementation of the 21 CFR part 11 compliance in clinical studies, but Part 11 compliance is requested for every quality management system record if it is collected electronically, isn’t?

  • Reply

    Thank you Yana for your question and yes bingo any electronic record for QMS or even mfg of devices, biologicals, and drugs will be reviewed by your friendly FDA investigator when they audit your site. I elude to this in the moral of the story part of this post. I consider health care manufacturers as drugs, devices and biological entities. Any FDA regulated product that uses e-records & e-data is legally fair game for following 21 CFR part 11 guidance and “predicate rules”. The FDA has given industry many years to incorporate these rules and now its time for them to check under your hood & get to work. Are you ready out there?

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