10 Things to Know
21 CFR Part 11 is a section of Title 21 of the Code of Federal Regulations that authorizes the U.S. FDA rules and regulations related to electronic records and electronic signatures (ERES). It outlines the criteria which designate ERES to be a reliable equivalent to paper records. Here are ten important things you need to know about 21 CFR Part 11.
- Part 11 mandates that closed and open computer systems must have controls to protect data and keep it confidential.
- All computerized data storage systems containing information that is reported to the FDA or used to make Quality decisions must be Part 11
- To be compliant the computer system must meet validation requirements. This means that the system owner maintains validation documentation including testing protocols and requirement specifications.
- All data entered into the system must be retrievable without changes being made.
- Procedural controls must be maintained to ensure records are not corrupted.
- A system owner must show that s/he is aware of who is accessing the data at all times.
- System owners must keep an audit trail. This is a log that is internal to the system and designed to record all changes to system data.
- Regular device checks must be made. This means that checks must be made to ensure that operational instructions and all system data inputs are accurate.
- All system users must be specifically trained to use 21 CFR 11 compliant programs.
- When using electronic signatures, all users must acknowledge awareness of their responsibility for any data entered or edited within the system.
When you need a system that is 21 CFR Part 11 compliant, contact Innovatum. Our experts know all there is to know about enterprise software systems for the compliance challenges of highly-regulated industries. We have years of experience implementing ERP and enterprise labeling systems and integrating the two in validated Part 11 compliant environments.