Validation: When and What Does FDA Expect You to Validate?

Q: A lot of different areas need validation, which leads to concerns in my company about over-validation and its associated costs. Is there a test to make sure we actually have to validate a given piece of hardware or software?

A: It depends on your product. Medical devices, for example, are very simple because the regulations are clear. If a device manufacturer uses computerized systems for any manufacturing or quality purpose, those systems must be validated. That includes anything and everything.

[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]Too many companies define their requirements in a very broad way…so the validation becomes very lengthy and time-consuming.[/pullquote]

Otherwise, validation should be based on your company’s use of the system and your risks. Unfortunately, too many companies define their requirements in a very broad way and end up with lots of requirements, so the validation becomes very lengthy and time-consuming. Instead, you should focus on the real requirements of the system — what you expect the computerized system to do. You’ll then find you’re producing far smaller documents that are more meaningful and actually help maintain the system.

Answered by Martin Browning, President and Co-Founder of EduQuest and Co-Author of the original Part 11 rule. For more information on FDA expectations, attend EduQuest’s 3-day training class, FDA Auditing of Computerized Systems and Part 11/Annex 11 Compliance.


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