Part 11 for Entrepreneurs

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If you are here, it’s because of a client meeting where evidence of “Part 11 Compliance” was requested or you received a questionnaire asking for the same. This is a very common scenario, so no need to worry. You are definitely not alone.

So, let’s start with – What is Part 11 and Why do your clients care?

Part 11 is shorthand for – US Code of Federal Regulations Chapter 21, Part 11.

Simply put, the requirements contained in “Part 11” ensure that e-records and/or e-signatures used to demonstrate FDA compliance are – trustworthy, reliable, and equivalent to paper records and manual signatures.

You can offer most user friendly, feature rich, secure, and reliable system in the world to Pharma and Medical Device clients. However, unless your system is also Part 11 compliant, they will not purchase it. They don’t want FDA writing them up for not having required records or signatures.

Without Part 11 compliance, the e-records and e-signatures in your amazing system are – worthless.

Next, let’s discuss – When does Part 11 apply?

There is a two-part test to determine if Part 11 applies:

Test 1 – Is there a specific FDA requirement for a record and/or a signature to be generated?

If yes, go to Test 2. If no, then stop. Part 11 is not applicable.

Test 2 – Is this requirement going to be satisfied using e-records and/or e-signatures?

If yes, Part 11 applies. If no, then Part 11 is not applicable.

Example of a specific FDA requirement:

21 CFR Part 820.30 – Design Controls

(c) Design input. … The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.

If the specific requirement highlighted above (blue text) is satisfied with a paper document with manual signatures, then Part 11 DOES NOT apply. However, if e-records and e-signatures satisfy this requirement (e.g. if you are developing a software like JAMA), then Part 11 applies.

Finally, let’s discuss  How is Part 11 compliance demonstrated? 

Precision is critical in demonstrating Part 11 compliance. There are two sets of requirements in Part 11 – one for electronic records and another for electronic signatures. Based on the specific requirement(s) that your system is satisfying, one or both sets will apply.  

Each individual clause included in applicable set within Part 11 then needs to be either: 

  1. Satisfied via procedural or technological controls 
  2. Denoted as – Non-Applicable, with proper justification.  

Vital Compliance has helped many clients turn Part 11 compliance into competitive advantage. Feel free to contact us if you have any questions.  

Free Tool for DIY’ers – The attached checklist facilitates detailed review of each Part 11 requirement, and documentation of your controls.