All companies serving industries regulated by the FDA must follow the regulations included in Title 21 CFR Part 11. With these new regulations and procedures, the FDA ushered in the use of modern technology for records and submissions. The regulation made electronic records and signatures as valid as paper records and handwritten signatures. Part 11 does not 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 using electronic records as much as possible while at the same time safeguarding the integrity of data and systems and the validity (or nonrepudiation) of electronic signatures.
Compliance with Part 11 is determined by how a business implements and utilizes its electronic systems. Compliance requires implementing management and procedural controls, including, but not limited to, notifications, training, standard operating procedures (SOPs), and disciplined administrative governance.
Choosing a system that supports these requirements is essential for businesses that want to comply. 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 companies achieve compliance with Part 11.