Design Compliance Architecture

Establish the top-level compliance framework that maps regulations to systems, classifies criticality, and defines governance for a regulated environment.

When to Use

• A new regulated facility, department, or programme is being established
• An existing organisation needs to formalise its compliance posture across multiple systems
• A regulatory gap analysis reveals missing system classification or validation strategy
• Mergers, acquisitions, or reorganisations require harmonising compliance across entities
• Preparing a site master file or quality manual that references computerized systems

Inputs

• Required: List of computerized systems in scope (name, purpose, vendor/custom)
• Required: Applicable regulatory frameworks (21 CFR Part 11, EU Annex 11, GMP, GLP, GCP, ICH Q7, ICH Q10)
• Required: Organisational context (department, site, product types)
• Optional: Existing validation master plan or quality manual
• Optional: Previous audit findings or regulatory inspection observations