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Conval Group offers a complete range of Computer System Validation (CSV) and 21 CFR Part 11 services/solutions to companies operating in the FDA regulated environment.

Food and Drug Administration (FDA) regulation 21 CFR Part 11 has a profound impact on the Life Sciences Industry and we can help you meet the challenges. This regulation introduces specific controls on the use of electronic records including strict administration of electronic signatures. Electronic records will supplant paper records while electronic signatures will become as secure and legally binding as handwritten signatures. For FDA regulated companies, the path to compliance with 21 CFR Part 11 requires transitioning current systems and establishing an appropriate ongoing validation environment.