21 CFR Part 11 compliant e-signatures right where your content lives Life Sciences organizations face many challenges as they look to innovate and improve patient outcomes - 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 to digitally transform and to help meet FDA regulatory requirements while providing the security, compliance, and collaboration capabilities needed for regulated processes. Soon, Box will bring support for 21 CFR Part 11 compliance to electronic signatures, extending the benefits of GxP Validation to all business processes that require signatures. GxP Validation customers will be able to leverage unlimited, native e-signatures for 21 CFR Part 11 compliance at no additional cost — enabling them with an alternative to expensive, standalone e-signature providers and add-on 21 CFR Part 11 e-signature modules. This empowers your organization to transform and automate your signature and approval workflows by addressing a number of use cases, including clinical trial enrollment, R&D documentation, new drug applications, and more. With support for 21 CFR Part 11 compliance in Box for both electronic records and e-signatures, organizations can boost productivity, speed up R&D, and reduce costs and complexity right where their content lives.
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