Box and 21 CFR Part 11 Compliance

Now more than ever, life sciences organizations need to innovate quickly to improve patient outcomes and get new molecules and devices to market faster. On top of that, they face many major challenges: disrupted clinical studies, growing competition, increased regulation, and the need to increase manufacturing and distribution efficiency to name a few. Manual, paper-centric business processes compound these challenges, exposing a significant need for digital transformation – to help meet FDA regulatory requirements while providing the security, compliance, and collaboration capabilities needed for regulated processes.

For life sciences organizations looking to fully digitize their product development use cases, Box can be configured to support 21 CFR Part 11 compliance for both electronic records and electronic signatures, providing a single platform to manage regulated and non-regulated content. With support for 21 CFR Part 11 compliance in Box, organizations can boost productivity and speed up R&D by converting manual, paper-based processes to digital document workflows. Organizations using standalone 21 CFR Part 11 modules for e-signatures can also benefit by significantly reducing IT costs and complexity while accelerating work with natively integrated e-signatures, right alongside their content in Box.

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