A Stress-Free Solution to Simplify 21 CFR Part 11 Compliance

Summary•3 min read

Implementing a fully digital, modernized System of Agreement requires technology that simplifies compliance with the FDA’s rigorous 21 CFR Part 11 standards.

By Seonah Iverson, Product Marketing Manager, Docusign

Life sciences leaders don’t have to strain their memories to recall when new technology investments came with daunting and costly compliance requirements. Even now, the prospect of adopting new technologies can be paralyzing. But it shouldn’t be.

Complacency can be a devastating competitive disadvantage for today’s life sciences organizations. The good news is that modern cloud technologies are not only more efficient but far simpler to validate. As a result, life science leaders are making technology investments with an eye to the future—rather than letting outdated compliance fears cloud their decision making.

One of the most impactful tools in today’s digital life sciences toolkit? A modern System of Agreement. By connecting and automating their System of Agreement, life science companies can simplify their processes to accelerate product development by enabling more efficient patient onboarding, clinical trial operations, and global supply chain management - ultimately resulting in a compressed time-to-market for new products. While the benefits are undeniable, implementing a fully digital, modernized System of Agreement requires technology that simplifies compliance with the FDA’s rigorous 21 CFR Part 11 standards.

Meeting global regulatory standards doesn't always have to mean increased costs or complexity. In fact, e-signatures and digital agreements can not only improve overall compliance at your life science organization but also improve other critical business outcomes.

With Part 11 Compliance, You’re Not Alone

“Digitizing” does not merely mean replacing legacy processes with software. It means adopting new technologies that make those processes more efficient. And for life science IT leaders, adopting new technologies requires an additional—and critical—step: updating compliance processes to validate the new tools and technologies and to reduce regulatory risk.

At Docusign, we don’t make our customers navigate compliance alone. That’s more than 300 Docusign life science customers trust us to help make 21 CFR Part 11 compliance simple and cost effective with our Part 11 Module. Docusign also offers the industry-leading product validation solution, Docusign Validator for Life Sciences, that automatically tests and verifies compliance of the Part 11 Module with regional and global regulations. With the Validator, customers can complete regulated processes with the ease of automated testing and reporting in accordance with Part 11 regulations.

The fear of increased validation and implementation costs should not keep a life sciences company from adopting a modern, transformational System of Agreement platform. As a proven innovator with a dedicated life sciences team, let Docusign help you navigate the complex world of Part 11 compliance.

Learn more about how Docusign addresses every aspect of 21 CFR Part 11 and our team’s commitment to making it simple for our clients to achieve compliance.