Title: Electronic Records Document Control
Course: PW-Course-Import-Test > Section: Module 3: Document Control

Module 3

What about electronic records, documents and signatures? What is 21 CFR Part 11?

As technology continues to evolve, the challenges for compliant document control have also advanced, and so current practices within the medical device industry change to keep pace. When the regulations were originally written, paper based document control systems were common. In today’s world, software platforms can manage document libraries more efficiently and effectively. As more firms adopt electronic systems for controlling and processing documents, the requirements for electronic signature approval and electronic tracking of documents and document changes has continued to evolve. The regulatory requirements related to electronic document control processes can be found in 21 CFR Part 11. Part 11 defines requirements for electronic signatures and is directly applicable to Document Control if you are using an electronic system to manage documents, including electronic reviews and approvals. Electronic signatures may be utilized in software applications in which a firm elects to control documents electronically.

Read

Read 21 CFR Part 11.

Watch

Review this video for an overview of requirements.Title  21 CFR Part 11