Increasing usage of electronic methods to capture and produce critical data, which are subject to regulatory scrutiny led to the effect of Title 21 CFR Part 11. This part of the Code of Federal Regulations establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures.
The aim of this regulation is to define the criteria under which the agency will consider electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
The FDA released a guidance document in 2003 to clarify how part 11 should be implemented and enforced. This has been updated many times, partly due to the fast-emerging changes in technology. In June 2017, the FDA also issued a draft guidance on the use of Electronic Records and Electronic Signatures in Clinical Investigations.
The FDA takes accountability of electronic signatures very seriously and upon inspection of these records deficiencies may result in a warning letter.
These constantly evolving rules can be daunting to understand and implement. EAS’ team of experts is available to assist your firm in understanding your requirements under 21 CFR Part 11 as well as assess your compliance. Areas in need of strengthening will be addressed giving your firm a detailed action plan for maintaining compliance for both signatures and storage of electronic data.