Computer System Validation Project Delivery
Your last minor change control took as long as a full system replacement.
One partner for the full validation lifecycle
• End-to-End CSV pharma project delivery
GxP Applicability Assessments, URS & specification drafting, ICH Q9 risk assessments, IQ/OQ/PQ execution, ERES assessments, and infrastructure qualification.
GAMP 5 Lifecycle · IQ / OQ / PQ · 21 CFR Part 11 Compliance
• Operations & lifecycle support
Periodic Reviews, Audit Trail Reviews, Change Management, Data Integrity oversight, Re-validation, and system retirement — maintaining your validated state long after go-live.
Change Management · Periodic Reviews
• IT & OT systems validation
From enterprise platforms (MES, LIMS, eQMS) to large automation systems (DCS, SCADA, BMS) and lab instruments – covering Emerson DeltaV, Siemens PCS7, AVEVA Pi, and more.
MES / LIMS / eQMS · DCS / SCADA / BMS · Lab Instruments
• Flexible CSV resourcing
Qualified computer system validation services specialists embedded in your team or engaged per project – covering peak validation workload, staff turnover and periodic review backlogs without the cost of permanent headcount.
Embedded Specialists · Project & Interim Cover · Scalable Capacity
• Digital Validation Platform (DVT)
100% digital validation packages for SaaS and automation systems – web-based electronic records, version control, and Part 11 / Annex 11-compliant electronic signatures, leverageable directly into qualification.
Electronic Records · Electronic Signatures · SaaS Validation
• Advisory, audits & training
GAMP 5 validation and risk-based gap assessments, CSV framework optimisation, SOP reviews, corporate GxP training, quality and compliance consulting, and supplier qualification — building durable internal capability.
Gap Assessments · CSV Audits · Corporate Training
What you get?
When an inspector asks you to show that a change to a GxP system or GxP compliance was risk-assessed, tested, and approved, you have hours, not days, to produce the evidence. Gaps in that chain are what get written up as a deviation from your own Pharmaceutical Quality System. Traceable documentation turns that evidence into a retrieval task: the risk rationale, the URS-to-test-case linkage and the approved change record come out of one place, instead of a scramble through shared drives and email threads. Here’s what that gives you:
- Documentation you retrieve on demand, not reconstruct under audit pressure
- Shorter cycle times, since low-risk changes stop consuming high-risk documentation effort
- One partner across IT and OT instead of separate vendors for MES, SCADA, and your eQMS
- Systems that stay in a validated state through operational use as part of ongoing validation lifecycle management – and are returned to it, with documented evidence, at the close of every change project
