Validation & Documentation

We specialise in supporting major companies with the creation and management of critical documents.

Some of the critical documents we support the creation of are Change Requests (CR), User Requirement Specifications (URS), and Functional Design Specifications (FDS), ensuring that every stage of the production lifecycle is thoroughly documented and validated.

This expertise extends to safety and risk assessments, including Safety Data Sheets (SDS), Apparent Cause Analysis (ACA), Traceability Matrices (TRM, CAL), and advanced methodologies like Concurrent and Process Failure Mode and Effect Analysis (cFMEA, pFMEA), as well as Hazard and Operability studies (HAZOP).

We guide clients through rigorous testing protocols; Factory Acceptance Tests (FAT), Site Acceptance Testing (SAT) and comprehensive validation planning and reporting (VMP/VPL, VPR/VMR).

Our team ensures seamless qualification processes, covering Installation, Operational, and Performance Qualification (IQ, OQ, PQ), all tailored to meet the stringent requirements of ISO 13485.

By leveraging this structured approach, we help organisations achieve robust traceability, risk mitigation, and regulatory assurance across all roles involved in production and validation.

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