Examining 21 CFR Part 11 and the Role of Technology – Q&A (Part I)

Tom Beatty
Sr. Principal, Life Sciences, QPharma
February 28th, 2014

We had a great response to our webinar, “Examining 21 CFR Part 11 and the Role of Technology.” As a follow up, here are answers to some of the questions asked during the presentation.

 Do EDC Systems used in academic institutions need to be 21 CFR Part 11 compliant?

 If the EDC system is being used to collect clinical trial data that will be submitted to the FDA as evidence to be considered by the Agency in evaluation of a drug or device approval, the system would need to be Part 11 compliant in alignment with the Predicate rules for Part 312 (drugs) or Part 812 (devices).

 If an EMR has a research component where trials, agreements and financials are housed within the EMR, and the EMR is shared between two separate clinical trial sites, does it then need to be 21 CFR Part 11 compliant?  Is it ok that site A can access all the confidential documents of site B when Site A is not contractually included in the study?

 In general, EMRs at Investigator Sites are considered to be general patient medical records, and as such they are considered to be part of the practice of medicine which is not regulated by the FDA, nor are they presently required to be 21 CFR Part 11 compliant. The FDA expects, however, that their inspectors be provided the ability to review any information in the EMRs that is source data for the study in question.

 Do IRB processes fall within Part 11?

 Regulations for IRB’s are covered under Predicate Rules – 21 CFR 50 (Protection of Human Subjects), 21 CFR Part 56 (Institutional Review Boards) and 21 CFR Part 312 (INDA – Drugs) or Part 812 (IDE – Devices), and possibly others.  Since the IRB activities are covered under these Predicate Rules, the electronic records are required to be Part 11 compliant.

Be sure to read Tom’s Q&A Part II to learn more about 21 CFR Part 11 validation. And register for our free, upcoming webinar, Understanding, Achieving and Maintaining 21 CFR Part 11 Compliance to learn more about the roles organizations and vendors play in validating an EDC system.