GregPLC
Member
Hey everyone, I just finished an integration which was a 21 CFR part 11 compliant project. Just curious if anyone on here has traveled this road also? For those who don't know what this is, it's an FDA compliance when you are replacing handwritten signatures on legal process data with electronic signatures.
We integrated a paperless chart recorder, which replaced a paper strip chart recorder. The recorder met the 21 CFR part 11 compliance, but it was up to us to make the entire system compliant. We're in the aseptic food processing industry and we answer to the FDA and USDA. This is where this compliance applies. Anyone else been down this road yet?
Greg
We integrated a paperless chart recorder, which replaced a paper strip chart recorder. The recorder met the 21 CFR part 11 compliance, but it was up to us to make the entire system compliant. We're in the aseptic food processing industry and we answer to the FDA and USDA. This is where this compliance applies. Anyone else been down this road yet?
Greg