GxP Compliance

GxP is a general term used to represent the FDA regulations governing Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice, as well as Electronic Records and Electronic Signatures.

GxP Compliance refers to the compliance of the many processes implemented and executed as part of the research practices that are subject to these regulations.

Understanding FDA's Part 11 Regulation

In today’s world, much of our data is maintained in electronic format. This means that we must protect and ensure the integrity and security of our electronic data if we expect it to be reliable, reproducible and accurate. In 1997, the FDA issued its regulation on Electronic Records and Electronic Signatures (21 CFR 11) which defines FDA’s criteria for considering electronic records and electronic signatures to be:

Trustworthy

Reliable

Paper Record Equivalent

The FDA has since issued several guidance documents (see Resources and Tools) to assist researchers in complying with this regulation, which remains in effect today.

FDA-regulated research must comply with FDA’s regulation on Electronic Records and Electronic Signatures, known as “Part 11” (21 CFR 11).

When does Part 11 apply?

It applies to records:

• Electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements (predicate rules) set by the agency (FDA).
• Required to be maintained under predicate rules:
  • Maintained in electronic format in place of paper
  • Maintained in electronic format in addition to paper format and that are relied on to perform regulated activities
• Submitted to FDA in electronic format under predicate rules (even if such records are not specified in agency regulations)

What are Predicate Rules?

Any FDA regulation that requires certain records to be maintained or submitted to the agency.

• Compliance oversight and collaboration with Research Information Technology on the validation of computerized systems used in FDA-regulated research
• Point of contact for information related to FDA's Part 11 regulation
• Training on FDA's 21 CFR Part 11 regulation
• Quality Assurance services
• Creation of institutional policies for clinical research
• Compliance liaison with UM's GMP manufacturing facilities

Contact the Director of Research Quality Assurance for questions related to:

• FDA’s regulation on Electronic Records & Electronic Signatures (21 CFR 11)- aka “Part 11”
• Determining if an electronic system used in clinical research is, or needs to be, Part 11 compliant
• Computer system validation records

Inquiries from external auditors, including federal agencies and industry sponsors, related to Part 11 or computer system validation records.