21 CFR Part 11
21 CFR Part 11 and Data Management for Data Integrity
21 CFR Part 11 is the most widely used standard for appropriate data management. Part 11 applies to records in electronic format that are created, modified, maintained,
archived, retrieved or transmitted according to requirements set in FDA regulations. Electronic records/signatures that meet Part 11 requirements may be used in lieu of paper records.
The document is divided into three parts:
- Electronic Records
- Digital Signatures
- Audit Trail
The General Provisions section gives an overview of the terminology used throughout the document and the types of records that apply and do not apply. The following are essential terms to be familiar with:
- Electronics Records
Electronic records include text, graphics, data, audio, pictorial, or other information in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. These records must contain data and metadata in a legible format. In addition, they must be ready to retrieve during the entire period of retention.
- Digital Signature
A digital signature is an electronic signature based on cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.
- Audit Trail
An audit trail is a documented, chronological record of system activities with details of how the activities have affected a specific operation, procedure, or event. The audit trail is comprised of records that are secure, computer-generated and time-stamped, and contains the who, what, when and why of the record.
The FDA recommends a review of audit trails that captures changes to critical data alongside each record before final approval of the record.
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