Speed up biopharma approvals with Box Sign CFR 11

If you work in life sciences, then you’ve probably heard the old adage, “If it wasn’t documented, it didn’t happen.” At Box, we’re here to help you bring that statement to the digital era.

We know you’re working in an industry where speed to market has life or death consequences. Ensuring compliance with global regulatory standards is table stakes. And while compliance overhead is generally a rate-limiter, it’s also necessary as you maintain the quality and efficacy of drugs and devices. 

Unfortunately, these limitations have slowed down the adoption curve on digital transformation and the adoption of relegated technology, as organizations focus only on certain points of the content life cycle. 

A workplace evolution plagued by variety

The 21 CFR Part 11 regulation dates back over 25 years ago to its first release in 1997. Its purpose was to establish criteria for the reliable use of electronic records and electronic signatures in place of paper records and handwritten signatures.

Organizations went from the truckloads of paper normally required for regulatory submissions — to time and energy-saving digital solutions. Initially, the adoption of Enterprise Data Management (EDM) solutions with built in e-signatures proved a game-changer. But general adoption of digital transformation proved slow, with biopharma falling behind and still using multiple paper-on-glass solutions. 

As companies began moving to cloud, more point solutions for different phases of work emerged. Along the way, tons of e-signature solutions began popping up to support just one part of the process — e-signature approvals. Rather than speeding up work, these silos led to slowdowns. 

The cost of complexity

Another major problem is that even with 21 CFR Part 11-compliant cloud solutions, teams still have to manually move files from one source to another. You might start early stages on one platform, and draft or collaborate in another. Plus, you’re dealing with different post-approval publishing and archive locations. Add in the rising cost of your entire ecosystem of apps (including sourcing, overhead, and integrations), and you’re looking at unmanageability, from upstream to downstream locations.

Clearly, just going digital doesn’t cut it. You need a single content layer across your entire organization to support better user experiences. You need a way to reduce management overhead for administrators, while cutting costs and curbing app sprawl. 

There’s a better way: Introducing Box Sign Part 11 e-signatures

Now that you have an understanding of the challenges your industry faces, it’s time for a sigh of relief. 

Box gets that precision and accuracy are paramount in the fast-paced world of biopharmaceuticals. We know you need one easy, secure place to request and manage e-signatures at high frequency across your biopharma value chain. That’s why we’re thrilled to announce the release of Box Sign Part 11 e-signatures, bringing you simple launch approvals on all your collaborative documents across both internal and external partners. 

That includes all your clinical and manufacturing documents, such as study protocols and work instructions. Plus, you have access to unlimited, e-signatures that can be used across various R&D workflows, as well as manufacturing processes right where the content lives. In addition, you can leverage the best-in-class security that Box customers know and trust. Your audit trail never had it so good. 

With the release of Box Sign Part 11 e-signatures, life sciences customers at Box can unlock efficiency across biopharma like never before. Join the Box webinar on January 18th to learn how you can streamline your high-frequency e-signature workflows by leveraging Box Sign to support your 21 CFR Part 11 e-signature needs.