Legal & Compliance

Design Compliance Architecture

Design a compliance architecture that maps applicable regulations to computerized systems. Covers system inventory, criticality classification (GxP-critical, GxP-supporting, non-GxP), GAMP 5 category assignment, regulatory requirements traceability, and governance structure definition. Use when establishing a new regulated facility, formalising compliance across multiple systems, addressing a regulatory gap analysis, harmonising compliance after mergers or reorganisations, or preparing a site master file that references computerized systems.

Publisher / source
pjt222/agent-almanac (found on the CSV list)
Upstream record
pjt222/agent-almanac
Version
Version 1
Published
Publication review
Approved for publication · recorded passed scan 2026-11-03
Content fingerprint
c5fd84ce2fb21f7b6bd509c3cc768bfb2a02f6a9cfa6e75a7d3eb267d956cd38