Validation & Compliance
Rigor an inspectorcan't unpick.
Every engagement is scoped risk-based: enough rigor to defend in front of any inspector, none of the over-validation that burns your budget. Delivered against GAMP 5, 21 CFR Part 11 and EU Annex 11.
The method
Risk in, evidence out
We categorize each system, concentrate testing where the risk actually lives, and trace every requirement to the evidence that proves it.
Scope of services
What we validate
From a single standalone instrument to a site-wide remediation program, the discipline is the same. Expand any line for detail.
Standalone, server-based, PLC, HMI and DCS systems validated end-to-end with a risk-based GAMP 5 approach — from planning through release.
Full lifecycle validation of enterprise systems — ERP, LIMS, MES and lab software — including supplier assessment and configuration verification.
Protocol authoring and on-floor execution of installation, operational and performance qualification, with deviation handling and traceability.
System categorization and functional risk assessment using GAMP 5 categories and FMEA, so validation effort lands where the risk actually is.
Audit-trail review, access-control evaluation and ALCOA+ gap assessment across paper and electronic records — with a pragmatic remediation plan.
Site-wide 21 CFR Part 11 and EU Annex 11 gap assessments, remediation roadmaps, and SOP authoring your teams will actually follow.
Documentation review, mock audits and inspection-readiness coaching so an FDA or EMA visit is a walkthrough, not a scramble.
What you receive
The validation package
A defensible package is not a stack of paper — it is the clearest description of how your system works that will ever be written.
Next step
Have an audit on the calendar?
Tell us the system and the date. We will scope a risk-based plan that is ready to defend when the inspector arrives.