Core capabilities
- Validation master planning
- C&Q protocol lifecycle
- Digitized traceability matrices
- Software validation and Part 11 readiness
- Deviation reduction coaching
Service capability
Validation engineering and CQV (Commissioning, Qualification, Validation) that survives inspection.
Integrated validation programs for facilities, equipment, software, and process systems across global sites.
Execution deliverables
- Validation plan and protocol library
- Digital trace matrix exports
- Inspection-ready summary package
Compliance framework
FDA 21 CFREU GMP Annex 15ICH Q9GAMP 5
Typical engagement
Greenfield Biotech Site
End-to-end CQV program across 220+ systems with stage-gate governance and batch-release acceleration.
Typical engagement
Legacy Facility Remediation
Risk-ranked retrospective validation and CAPA closure to restore inspection confidence in 14 weeks.