Risk-based CSV strategy and assurance for modern regulated environments, with clear decisions, proportionate evidence and traceability you can defend under inspection scrutiny.
The objective is not more documentation. It is a coherent, defensible validation narrative with evidence proportionate to risk and system criticality.
Delivery is aligned to GAMP 5 and CSA principles. Where electronic records and signatures apply, controls are mapped to 21 CFR Part 11 and EU Annex 11 expectations.
Explicit scope, decision rationale, deliverables and evidence expectations, agreed before work begins.
Recorded assumptions, criticality ratings and acceptance criteria aligned to intended use.
Testable requirements and RTM aligned to intended use, traceable from design through to release.
IQ/OQ/PQ as appropriate to risk and technology, with execution oversight and deviation handling.
Supplier assessment, shared responsibility records and release evidence pack structure.
Final reporting aligned to inspection expectations, with a clear residual risk statement and BAU handover.
If your system type is listed here, the regulatory context and assurance expectations are already understood, with no learning curve at your expense.
Based on a genuine engagement. Details are anonymised, and in some cases composited, to protect client confidentiality.
A mid-size biologics manufacturer was preparing for commercial site readiness and needed to validate a new LIMS implementation within a compressed timeline, alongside an existing backlog of partially-validated legacy systems. Multiple contractors had contributed deliverables over several years without a unifying strategy or risk framework.
The validation programme had no coherent master plan. Traceability between requirements, risk decisions and test evidence was incomplete across several systems, leaving gaps that would have been visible immediately to an inspector. A consolidated view of the CSV programme simply did not exist.
A master validation plan was established covering all in-scope GxP systems. The evidence backlog was rationalised against a risk-based prioritisation model, legacy gaps were formally remediated with documented rationale, and IQ/OQ/PQ documentation for the new LIMS was delivered to GAMP 5 and CSA-aligned standards with a complete traceability matrix.
The LIMS was validated and released to production on schedule. The legacy remediation programme was closed with a formal summary record. At a subsequent MHRA inspection, no observations were raised relating to computerised systems.
Book a call to discuss your environment. Fixed scope, senior delivery, inspection-ready output.