What is 21 CFR Part 11?

21 CFR Part 11 is an FDA requirement for electronic record and electronic signature. If you are an establishment who are engaged in manufacturing of a medical device or drug or your establishment is a biotech company, biologics developers, CROs, and other FDA-regulated industries, you must comply with 21 CFR Part 11 for electronic records and signatures. Not complying with 21 CFR Part 11 may result in FDA citations.

Do you know that even Microsoft office programs like Excel Spreadsheet, MS Access application/database used in your establishment may be subject to 21 CFR Part 11 compliance?


We can help:

All software and applications used in the above-mentioned establishment may require validation to comply with 21 CFR Part 11 requirement.

With our experience with medical device industries, we can help you assess and document all of your software and applications against 21 CFR Part 11 requirement.

We can also help you develop a validation plan, validation process, and validation report if validation is required for certain software and application.

Fees & Charges

Contact us  for fees & charges..