FDA 21 CFR Part 11 Compliance

All companies that operate in industries that fall under the U.S. Food and Drug Administration (FDA) jurisdiction must follow the regulations included in Title 21 CFR Part 11

CFR Part 11 Electronic Records and Signatures

With these updated regulations and procedures, the FDA ushered in the implementation of modern technology for records and document submissions. The statute made electronic records and signatures as valid as paper reports and handwritten signatures. Part 11 doesn’t mandate the use of electronic systems. Instead, it specifies the requirements for companies that opt to use digital systems as part of their compliance efforts.

Part 11 encourages the use of electronic records as often as possible while at the same time safeguarding the integrity of data and systems and the validity (or nonrepudiation) of electronic signatures.

We Got You Covered

Businesses that want to comply must choose a system that supports these requirements. TraceGains’ networked platform is a highly flexible and configurable solution that allows companies to streamline and automate Part 11 compliance without modifying the software.

Check out our data sheet that outlines clearly how TraceGains customers secure compliance with Part 11.

Ensuring Compliance with Part 11

Regulators assess Part 11 compliance by how businesses implement and utilize their electronic systems. Compliance requires implementing management and procedural controls, including, but not limited to, notifications, training, standard operating procedures (SOPs), and disciplined administrative governance.

The Power of Networked

You’ve always been a superhero. We just help release your superpowers.

Related Content

Standardized Documents and Forms with PostOnce®

Standardized Documents and Forms with PostOnce®

Standardization is hard to come by in an industry where every company seems to use its own documentation. But ...
Connecting Your Supply Chain

Connecting Your Supply Chain

CPG manufacturers don’t have the luxury of taking their time when reacting to supply chain issues. That's why the ...
Fix the Top 10 Product Development Problems

Fix the Top 10 Product Development Problems

Today, the speed that food, beverage, and supplements companies create and refine formulas can make or break a ...

Pin It on Pinterest

Share This