Achieving FDA 21 CFR Part 11 Compliance with Surround SCM
Many life sciences organizations find it difficult to achieve compliance with the FDA’s 21 CFR Part 11 guidance on electronic records and electronic signatures. Their stumbling point is often version control for source code and other digital assets, because the tools they use don’t support electronic signature and audit capabilities. Surround SCM, however, has these capabilities built in. Surround SCM includes complete electronic version control, with the ability to capture electronic signatures at key points within a controlled process. With Surround SCM’s configurable workflow and versioning, you have complete assurance you are working with the correct version of source code, SAS data sets, text-based files, and many other digital assets that may not be managed or controlled well in other solutions.
Enhance Your QMS with Additional Control and Versioning
By itself, a traditional quality management system (QMS) can cause business interruptions; it doesn’t integrate with the other tools you use and it doesn’t fit the daily process you follow. Surround SCM doesn’t replace your QMS, but complements it by providing additional control and versioning for complex assets that require parallel development and tight security. Because Surround SCM is a source code management tool first, it has all the capabilities you would expect to manage assets:
- Check in/out
- Code reviews
What’s more, Surround SCM integrates with the tools you use the most throughout your development process.
Improve Data Analysis, Reporting, and Change Management
Going beyond traditional source code management tools, Surround SCM can be configured to keep non-software developers, such as analysts and statisticians, working in the tools they’re familiar with. They’ll be happy, because they won’t have to learn yet another tool with audit reporting and electronic signature assurance. Because Surround SCM manages large text-based and binary files in a relational database, you’ll experience better data analysis and reporting. And if you’re a TestTrack user, you get the added benefit of having these controlled assets automatically included in a traceability matrix report. The visibility of the associated work item is increased, as well, which allows for better change management.
Strengthen Data Security and More
Surround SCM also gives you more security controls and other features that allow you to:
- Limit access to authorized users
- Protect IP with encrypted security
- Record timestamps for each and every change
- Streamline and automate core processes with configurable workflow
- Authenticate core approvals with electronic signatures
- Report and validate electronic records for auditing
All of these powerful controls and features are combined in Surround SCM to give you improved version control and better compliance with FDA 21 CFR Part 11.
Learn more about 21 CFR Part 11.