All companies serving industries regulated by the U.S. Food and Drug Administration (FDA) must follow the regulations included in Title 21 CFR Part 11. 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 choose to use digital systems in 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.
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.
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 customizing the software.
Check out our information sheet that outlines how TraceGains customers secure compliance with Part 11.