A fully auditable evidence chain, delivered on the GAMP 5 V-model

The scope covers application validation and infrastructure qualification, and separates GxP-critical systems from non-critical ones — so validation effort goes where it genuinely affects product quality.

Following GAMP 5 and the regulations of the target market, verification depth is matched to the system's risk level: no over-validation, and no gaps either.

• Application validation + infrastructure qualification
• GxP criticality assessment and system classification
• GAMP 5 V-model methodology
• NMPA / FDA / EMA regulatory alignment
• Scope definition and documented exclusions

The validation plan (VP) sets out which systems need validating and how. The user requirement specification (URS) states the functional and compliance requirements item by item, and the risk assessment (RA) identifies where things could go wrong and how to prevent it.

Installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) then follow, closing with the validation summary report (VSR) so that every requirement traces back to evidence.

• Validation plan (VP)
• User requirement specification (URS)
• Risk assessment and controls (RA)
• IQ / OQ / PQ execution
• Validation summary report (VSR)

Validation is not a stack of documents — it is a traceable evidence chain. We build a requirement–risk–test–conclusion traceability matrix so any test result can be traced back to its requirement and its risk item.

Deliverables span the validation plan, requirement specifications, risk assessments, qualification protocols and reports, deviation records and the final validation summary report.

• Requirement–risk–test–conclusion traceability matrix
• Validation protocol and report templates
• Deviation handling and change control records
• Auditable electronic and paper documentation
• On-site support during inspections

Our CSV team understands the intersection of biopharmaceutical manufacturing processes and IT systems. We do not copy a checklist — we deliver a validation approach that genuinely reduces compliance risk.

During regulatory inspections and customer audits we provide document traceability support and on-site answers.

• Understanding of process / IT system intersections
• Data integrity and audit trails (ALCOA+)
• Change control and re-validation strategy
• Regulatory inspection and customer audit support