Facility Systems Expert

Detailed validation protocols and compliance standards.

Validation Standard

System Impact Assessment (SIA)

The process of evaluating the impact of a system on product quality to determine if it is "Direct Impact" (requires Qualification) or "Indirect/No Impact" (Commissioning only).

Installation Qualification (IQ)

  • Define system boundaries and functions
  • Evaluate impact on Product Quality (Identity, Strength, Purity, Safety)
  • Evaluate impact on Data Integrity
  • Determine Risk-Based Verification Strategy

Operational Qualification (OQ)

  • N/A - This is a strategic assessment phase.

Performance Qualification (PQ)

  • N/A

Acceptance Criteria

  • All systems categorized (Direct, Indirect, No Impact)
  • Rationale documented for each decision
  • Approved by Quality Unit (QA)

CRITICAL PROCESS PARAMETERS (CPPs)

Product Quality Impact Patient Safety Risk Data Integrity Risk