PSIcapture Documentation: FDA’s CFR 21 Part 11 regulation


We have customer who recently purchased Psicapture. Before we can implement their IT is requesting for compliance information on Psicapture.

Are there any compliance validation you can provide me? They are looking for FDA’s CFR 21 Part 11 regulations.


FDA CFR 21 Part 11 is regarding the authenticity, integrity, and confidentiality of all electronic records and signatures. PSI:Capture does not have any direct inputs for receiving signatures specifically for receipt and transmission of electronic records.

Does the entire product adhere to this standard?

No – Capture is a generic point of entry that takes in scanned images and outputs specific metadata.

Could a solution be generated that adheres to this standard?

Yes, it would most likely need to be a custom built solution via our Professional Services team.

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