The FDA posted a final guidance "Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers".
The Introduction notes the scope: "The use of electronic systems, electronic records, and electronic signatures in clinical investigations of foods, medical products, tobacco products, and new animal drugs. The guidance provides recommendations regarding the requirements in our regulations, pursuant to which FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper."
Later, it puts things more into scope on the technological changes since 21 CFR Part 11 was implemented: "FDA recognizes that since 2003, advances in technology have expanded the uses and capabilities of electronic systems in clinical investigations. In addition, electronic systems and technologies are used and managed in novel ways, services may be shared or contracted between organizations, and the electronic data flow between systems is more efficient and more prevalent. The capabilities of electronic systems have improved, and features such as automated date and time stamps, audit trails, and the ability to generate complete and accurate copies and to retain records are standard components of many electronic systems.
Accordingly, this guidance provides additional recommendations regarding the risk-based approach to validation described in the 2003 part 11 guidance to continue to ensure the authenticity, integrity, and confidentiality of electronic data and records for clinical investigations when they are created, modified, maintained, archived, retrieved, or transmitted."
The announcement with the link to the guidance:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-systems-electronic-records-and-electronic-signatures-clinical-investigations-questions?utm_medium=email&utm_source=govdelivery
#fda #electronicrecords #clinicaltrials
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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