In this new guidance document, the FDA affirms that it will continue to support a narrow and practical interpretation of Part 11, while at the same time reminding sponsors that electronic records must be maintained or submitted in a manner which satisfies all predicate rules. Additionally, this guidance clarifies and expands upon the policy announced in the 2003 part 11 guidance that encourages a “risk-based approach to the validation of electronic systems, implementation of electronic audit trails, and archiving of electronic records.”
This guidance document applies to electronic records and signatures in the following categories:
Records kept in electronic format in lieu of paper that are required for clinical investigations of medical products. This includes all records that would be necessary for the FDA to reconstruct a study.
Electronic records that are relied on to perform regulated clinical study activities.
Records pertaining to clinical investigations that are submitted to FDA in electronic format under predicate rules, even if these records are not explicitly identified in FDA regulations.
Electronic signatures required for clinical investigations that are intended to be the equivalent of handwritten signatures executed on paper.
The following electronic systems used in clinical investigations are addressed by the guidance in terms of their applicability to Part 11 requirements:
Electronic systems, whether commercial off-the-shelf (COTS) or customized, that are owned or managed by sponsors and other regulated entities
Electronic services that are outsourced by the sponsor or other regulated entities
Electronic systems that are primarily used in the delivery of medical care
Mobile technology and telecommunications systems