If your research is being conducted under an approved IND (investigational new drug), INAD (investigational new animal drug) or IDE (investigational device exemption), the computer systems used to collect and analyze data must be validated to meet the FDA requirements for electronic records. This includes audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data. Whether you are purchasing all or part of a system from a vendor or using your own system using university resources, you are responsible for demonstrating that the system meets 21 CFR Part 11. Part 11 inspections will now take place along selected regular GMP, GLP, and GCP inspections with a focus on electronic records regulation compliance. Not complying with 21 CFR Part 11 may result in FDA citations.
- Title 21 Code of Federal Regulations (21 CFR Part 11)
- FDA announcement 08-July-2010 (21 CFR Part 11)
FDA GUIDANCE DOCUMENTS:
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff (2002)
- FDA Guidance for Industry Part 11, Electronic Records: Electronic Signatures – Scope and Application (2003)
- Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices