End-to-end computerized system validation (CSV) aligned with EU GMP Annex 11, FDA 21 CFR Part 11 and GAMP 5, so your next inspection is a confirmation, not a crisis.
EU & US specialists — HPRA · EMA · FDA
Missing Annex 11 or Part 11 controls can mean warning letters, halted batches and records that are legally invalid. We build the validated, audit-ready environment that turns every inspection into a formality.
Inspection-ready evidence for EU GMP Annex 11, FDA 21 CFR Part 11 and EudraLex Vol 4 — accepted on both sides of the Atlantic.
Automated, attributable, audit-proof records. Regulators trust your batch and stability data on the first pass.
IQ / OQ / PQ done right, once. Structured methodology delivers most validations in weeks, not months.
ISO 27001, risk management and GDPR embedded across labs, manufacturing and patient data. Breach risk neutralized.
Trusted by Pharmaceutical, Medtech & Devices, Biotech and regulated Fintech across Europe and the United States.
A complete GAMP 5 lifecycle. One team owns every phase, every document, every signature, so nothing falls between the cracks at inspection.
Validation Master Plan, system Validation Plan and GAP analysis against the regulations.
User (URS), Functional, Design and Configuration specifications.
FMEA with RPN scoring and a full requirements traceability matrix (RTM).
IQ / OQ / PQ protocols and reports with objective, audit-ready evidence.
ALCOA+ assessment, audit-trail review, electronic signatures, backup & recovery.
BCP/DRP, change, incident, problem and CAPA management, SLAs and OLAs.
Access control (RBAC / SoD), vulnerability, asset and password management.
SOPs, training, system O&M, patch management and periodic review.
Supplier assessment, audit and qualification against GAMP 5 and ISO.
Validation Report, deviation closure and formal release to production.
One engagement, end-to-end. We build and maintain the entire compliance framework, so you're inspection-ready, always.
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