Organizations regulated by the Food and Drug Administration (FDA) are required to comply with Good Laboratory Practices {good laboratory practices} (GLP). GLP compliance requires organizations to have administrative policies, written procedures, competent personnel, and trained personnel. As part of GLP compliance, software products used in regulated organizations should comply with FDA regulations and document how compliance was achieved.
Code of Federal Regulations (CFR), Title 21, Chapter I, Part 11
Specific functions, electronic records, and auditing of software systems are required to be compliant with Code of Federal Regulations (CFR), Title 21, Chapter I, Part 11, Electronic Records; Electronic Signatures Final Rule (FDA CFR21 Part 11).
FDA CFR21 Part 11 requires accurate, reliable, and consistent software.
FDA CFR21 Part 11 does not necessarily require encryption.
FDA CFR21 Part 11 requires versioning of data and audit records.
FDA CFR21 Part 11 requires data to be entered in specific fields before processing.
FDA CFR21 Part 11 requires auditing.
FDA CFR21 Part 11 requires electronic signatures.
FDA CFR21 Part 11 has installation requirements. All necessary software components must be successfully installed and a report generated.
FDA CFR21 Part 11 has logon and logoff requirements. Systems limit access to only authorized persons, by checking user name and password. After a specific time period, automatic logoff occurs.
FDA CFR21 Part 11 has security requirements for data and audit record management, with file and operating system permissions. Attempts at unauthorized use are sent by electronic mail to the Administrator. User and user groups have privileges to files, directories, and functions. Systems can detect invalid or altered records. Auditing of user events detects creation, modification, and deletion of files, using checksums.
FDA CFR21 Part 11 requires instrument maintenance logs.
FDA CFR21 Part 11 has requirements for reporting data, parameters, and auditing information.
Physical Sciences>Chemistry>Biochemistry>Drug
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Date Modified: 2022.0224