[Whitepaper] Drugs & Devices to Market Faster with 21 CFR Part 11 Compliance

All parts of the product development cycle—clinical trial management, regulatory affairs, commercialization, and everywhere in between—have invested in technologies to support operational efficiencies and productivity gains. But there has always been a gap in these technologies: the inability to effectively manage transactions within an organization  and to extend beyond its four walls.

Paper-intensive processes, completed by scanning documents or sending them out for handwritten signatures, are increasingly embedded in automated workflows and digital systems, therefore rendering these processes “almost” paperless. The challenge in this digital evolution was that historically there was not a technology available to meet all of the FDA regulatory requirements while also providing the trust, security, and operational uptime needed to support the holistic digital transaction. Now there is a platform available to meet this need: The DocuSign Agreement Cloud.


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