Images of Product for Automated Process - How long to keep?

PeterLe

Involved In Discussions
#1
Hello everyone,

We are developing an automated process to inspect one of our components which take images and conduct a pass/fail result. Currently we are visually inspecting it 100%. One issue right now we have is, currently as our Material Requirements Specification document states X TB will be installed into the system, which is only 2-3 days worth of images. 2-3 days sound way too little. Is there a requirement per FDA or general best practices on how much data to keep? Archiving looks like the way to go but how much data should we keep?

Any advice would be much appreciated! Thanks!
 
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yodon

Staff member
Super Moderator
#2
The FDA regulations (21 CFR 820.180) establishes the record retention period:

All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.

If the images are used as evidence of passing any of the in-process or final acceptance tests, I would think they would be considered part of the DHF and, thus, be retained per the regulation. (There's another rabbit hole to consider: 21 CFR 11 - electronic records.)
 

PeterLe

Involved In Discussions
#3
Hello Yodon. I appreciate the response. These pictures are not included in batch records/DHF. Would that make a difference?
 
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