Non-compliance risks audit failures. Ensure your IT systems are fully compliant with EU and FDA regulations before the next audit.
We deliver end-to-end CSV, IT governance, and risk management for regulated industries across Europe and the United States, ensuring audit-ready, inspection-proof systems aligned with GAMP® 5, FDA 21 CFR Part 11, EMA, and EU GMP Annex 11, from implementation to legacy maintenance.
No validated audit trail or access control = system rejected. Missing Part 11 makes records legally invalid, product blocked at the U.S. border.
IQ/OQ/PQ gaps trigger silent equipment failures and million-dollar batch rejection. Every hour offline is unrecoverable revenue.
Without ALCOA+, any deletion or alteration falls on you. Regulators question every record. Executives have gone to jail for less.
Both Annex 11 and FDA Part 11 require pen testing, patching and incident response. A GxP ransomware hit stacks halted lines, GDPR fines and regulatory shutdown, at once.
Executives must personally certify compliance in the EU. Reactive remediation costs 3–5× more than acting now.
The EU GMP Annex 11 revision and strengthened FDA 21 CFR Part 11 enforcement represent the biggest regulatory shift in over a decade, and EMA, FDA and HPRA inspectors are already auditing against the new bar. Every quarter without validation compounds exposure to your license, your batches and your board.
Inspection-ready evidence for EU GMP Annex 11, FDA 21 CFR Part 11, EudraLex Volume 4 and ICH Q9 (R1), accepted on both sides of the Atlantic. Every audit becomes a confirmation, not a crisis. Zero warning letters. License risk eliminated.
Automated enforcement across every system complete, consistent, attributable. Regulators trust your batch and stability data on first pass. Falsification risk goes to zero.
GAMP® 5 validation with IQ/OQ/PQ, ISO 14971 risk management for medical devices and ISO 9001 + WHO Annex 2 across the supply chain. Silent failures, lawsuits and supplier rejection systematically removed.
ITIL 4 change control stops untested patches from breaking production. COBIT 2019 aligns IT spend with business value. Shadow IT and chaos gone.
ISO 27001 protecting manufacturing, labs and patient data. ISO 38500 & ISO 31000 governance accepted by every inspector. GDPR embedded. Breach risk neutralized, directors sleep better.
With a validated environment built on Annex 11, GAMP® 5 and ISO 27001, every inspection becomes proof, not a threat. Regulatory certainty, audit-ready evidence and executive peace of mind. Done right, once.
Every deliverable you need for a fully validated, audit-ready IT environment, from planningto decommissioning.
Our team has worked with HPRA, FDA and EU regulators. We know what inspectors look for, because we've been on both sides.
Structured methodology means we move fast without disrupting operations. Most validations completed in weeks, not months.
From initial risk assessment to audit-ready documentation, one team, one point of contact, full accountability.
We understand the European and American pharma landscapes, HPRA, EMA and FDA expectations
Trusted by regulated organisations across Europe and the United States' most demanding sectors
We don't just validate systems. We build and maintain the entire governance framework so you never face these risks again.
One engagement. End-to-end.
Inspection-ready, always.
© 2026 Quality Engineering. All rights reserved.