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Understanding the FDA’s thinking behind 21 CFR Part 11 inspections

21 CFR Part 11 is an FDA regulation that deals with electronic records and electronic signatures. 21 CFR Part 11 has a set of FDA regulations that define the various parameters that need to go into electronic records and electronic signatures for them to be considered genuine, that is, for these records to have the same trustworthiness, reliability and equivalency as those of paper records.

Any organization has to comply with the requirements set out in 21 CFR Part 11 to ensure that they can be considered as being equivalent to paper records and handwritten signatures.

The following come under the purview of Part 11:

o  Biologics developers

o  Biotech companies

o  CROs

o  Drug makers

o  Medical device manufacturers

o  Other FDA-regulated industries, with some specific exceptions

In other words, the provisions of 21 CFR Part 11 apply to organizations the life sciences industry. The provisions of 21 CFR Part 11 apply to areas that come under FDA regulated areas of research, such as researching, carrying out clinical studies, manufacturing, distributing and maintaining products.

The FDA has spelt out its best practices guidelines with regards to 21 CFR Part 11. These cover the following areas:

-       The Standard Operating Procedures (SOPs) and controls that go into supporting electronic records and signatures, which include measures such as, but are not limited to security, Computer System Validation and data backup 

-       The steps taken for ensuring the security of the computer system have audit trails for creating and tracking data values, which make electronic signatures reliable and trustworthy 

-       Steps to show proof that the system works according to what it is intended to, for which validation and documentation should be offered. Into this, the feature of helping users determine when a system is not working as it is intended to is also built in.

Punitive actions from the FDA on the rise

Experience has shown that 21 CFR Part 11 is an area in which the FDA has seen a high number of citations and other punitive actions. In only the last three years, the FDA issued no fewer than 30 Warning Letters that saw Part 11 violations. These actions have concerned not only the core areas of 21 CFR Part 11, namely integrity, availability and security of data; but also to validation of software and computer systems.

These findings are the result of the FDA’s renewed efforts at inspection and enforcement of Part 11 requirements. What makes these facts about the FDA actions intriguing is that for most part, these citations are against the Predicate Rules, rather than against Part 11 per se. All this lends credibility to the belief that there is widespread confusion about what the FDA is actually looking for in its inspections.

A useful learning session on Part 11 compliance

If companies in the life sciences industry, who are subject to Part 11 inspections, have to avoid these citations from the FDA; they need to first of all get a clear idea of what 21 CFR means and the reason and the manner in which it is being implemented. They next need to understand the enforcement part of Part 11 inspections from the FDA’s perspective. A grasp of these matters will help them prepare their company for Part 11 inspections.

The ways of getting these aspects right constitute the core of learning session from Compliance4All, a highly popular and renowned provider of professional trainings for all the areas of regulatory compliance. At this webinar, Angela Bazigos, a highly experienced regulatory compliance professional who brings over four decades in the industry, will be the speaker.

To steer clear of the entire muddle behind the Part 11 compliance, just enroll for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501346?...

In the process of giving a clear understanding of how to implement the provisions of 21 CFR Part 11 in a way that avoids actions from the FDA; Angela will be covering the following areas at this webinar:

  • 21 CFR 11 then and now: a brief history of 21 CFR 11 and what it looks like today
  • Part 11 Basics
  • FDA's view of 21 CFR 11 Compliance
  • FDA Acceptance of Data: Electronic & Paper
  • Computerized systems and eData
  • Basis for Part 11 Compliance and purpose of protection and validation
  • Diverse nature of "source" and how to protect and preserve it
  • Purpose and goal of 21 CFR 11 BIMO inspection
  • Inspection of electronic records - BIMO
  • The 10 Deadly Sins that break compliance
  • Examples of 21 CFR 11 Citations
  • How to prepare your company for successful part 11 inspections.

https://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm

https://www.microsoft.com/en-us/TrustCenter/Compliance/FDA#

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