Logilab SDMS solution for 21 CFR Part 11 Compliance requirements
Nature of Logilab SDMS and its applicability for 21 CFR Part 11
Logilab SDMS is a closed system. Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.
Hence the following subparts are applicable.
SUBPART B – ELECTRONIC RECORDS §11.10 CONTROLS FOR CLOSED SYSTEMS
SUBPART B – ELECTRONIC RECORDS §11.30 CONTROLS FOR CLOSED SYSTEMS
SUBPART B – ELECTRONIC RECORDS §11.50 SIGNATURE MANIFESTATIONS
SUBPART B – ELECTRONIC RECORDS §11.70 SIGNATURE/RECORD LINKING
SUBPART C – ELECTRONIC SIGNATURES §11.100 GENERAL REQUIREMENTS
SUBPART C – ELECTRONIC SIGNATURES §11.200 ELECTRONIC SIGNATURE COMPONENTS AND CONTROLS
SUBPART C – ELECTRONIC SIGNATURES §11.300 CONTROLS FOR
IDENTIFICATION CODES/PASSWORDS
Let us see one-by-one in the next few pages
1. Subpart B – Electronic Records §11.10 Controls for Closed Systems
Section: §11.10 (a)
Section Requirements:
Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
Logilab SDMS Approach:
Product is tested and released for customers. It is also validated against operational qualification tests which are performed during implementation with relevant documentation to justify the same. The product can discern invalid and altered records by the automatic versioning.
Section: §11.10(b)
Section Requirements:
The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency.
Logilab SDMS Approach
Data can be downloaded for copying, reviewing and printing by users with appropriate privileges. The original data will reside within the system in electronic format for any verification.
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