21 CFR Part 11

The V.P. of regulatory affairs wants to know if production is CFR21.11 compliant, what should I tell him?

Perhaps the hottest topic in FDA quality circles today is 21 CFR part 11, “Electronic Record and Signatures”. This tersely worded regulation has unleashed untold waves of production and quality system updates. As corporations strain to grasp the implications of this regulation, Putnam Technical Group has developed strategies for quickly accessing and achieving compliance. Give us a call, Putnam Technical Group can provide end to end solutions, from GAP analysis to final systems validation. We are your best solution for CRF 21.11 compliance.