Failure to validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70( i). For example, the firm did not validate software for electronic records and electronic signatures. Your written responses dated Feb. 25, April 3, and April 13,2000, stated that you would formalize the policy regarding electronic data and signatures and notify the FDA. However, you did not provide documentation. This response is inadequate.
Failure to fully implement procedures for control of all documents including electronic records and signatures, as required by 21 CFR 820.40. For example, the firm has not filly implemented procedures for control of all documents for their electronic record and electronic signatures.
Your written responses dated Feb. 25, April 3, and April 13,2000, stated that you would formalize the policy regarding electronic data and signatures and notify the FDA. You have not provided this documentation. This response is inadequate.
SoftwareCPR Keywords: Part 11 Electronic Record Electronic Signatures
