Validation Manager as a Service | GxP Lifecycle

Our services as an external validation manager

Validation Master Plan (VMP)

We plan the validation activities as a whole. The VMP defines scope, responsibilities, schedule and the standards applied. It is the reference against which every later document is measured, and the first thing an inspector asks for.

Equipment Qualification (DQ, IQ, OQ, PQ)

We run qualification from design qualification through to performance qualification. Each phase receives a test plan, executed protocols, assessed deviations and a report with a release recommendation. Details under Equipment and Facility Qualification.

Computer System Validation (CSV)

We validate computerised systems to GAMP 5 and 21 CFR Part 11, from configured off-the-shelf systems in Category 4 to bespoke software in Category 5. Scope and test depth follow from the risk assessment, not from habit. Details under Software Validation and CSV.

Process Validation

We cover the three stages of process design, process performance qualification and continued process verification. The basis is the FDA Process Validation Guidance and, for active substances, ICH Q7.

Audit Support and Inspection Readiness

We review the validation file before the inspection: missing signatures, open deviations, test results that cannot be traced. We then run a mock audit and prepare the responsible staff for typical inspector questions.

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Validation Manager guide

What should the Validation Manager solve?

Choose the focus for your validation programme.

Due dates and status in view

Coordinate and track due dates, owners and release status across many devices.

Book an intro call Qualification case story

Validation rarely fails for lack of expertise. It fails on capacity and coordination. Protocols sit with departments, deviations remain unassessed, dates slip, and in the end there is no evidence that the scope defined in the validation master plan was actually completed.

What You Receive

At project end you hold an audit-ready validation file – not just protocols, but a traceable chain from plan to release recommendation.

Validation master plan (VMP)

Scope, responsibilities, dates and standards in one approved framework – the reference for QA, subject matter experts and inspection.

Risk analyses with test depth

Per system or item of equipment: justified scope aligned with GAMP 5 and Annex 15 – not blanket coverage of every minor function.

DQ, IQ, OQ and PQ protocols

Executed protocols with evidence, assessed deviations and a release recommendation for each qualification stage.

Traceability matrix

End-to-end links from requirement through specification and test case to result – verifiable in QA review and audit.

Deviation and CAPA linkage

Deviation log with assessment, action and closure – including CAPA linkage where scope requires it.

Qualification and validation reports

Closing reports with release recommendation and an archivable documentation package for GxP routine operation.

Which artefacts do you need first?

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Our approach in GxP projects: from planning through release – each step delivers evidence you can present in QA review and audit. View GxP consulting in five steps

Why an External Validation Manager?

We fill that role for the duration of the project. You get one accountable contact for scope, dates and the evidence trail, without creating a permanent position.

Reviewing Eye

We check protocols against the specification and find test gaps before the audit.

Availability

Deployment during project peaks, new builds or absence of internal owners.

Templates

Proven templates for VMP, risk analysis, protocols and reports, adapted to your QMS.

Evidence Trail

Traceability from requirement to test case to result, with deviations closed.

Industries and Application Areas

The evidence logic is the same everywhere – the applicable framework mix differs by industry and system type.

Pharma & Biotech

Equipment and CSV programmes

Qualification of production and lab equipment plus CSV for MES, LIMS and ERP – aligned with equipment qualification and CSV.

Medical devices

MDR and process evidence

Validation under the MDR with focus on process validation, supplier qualification and documented design controls – see production plant qualification.

API & chemistry

ICH Q7 and process validation

Process design, PPQ and continued process verification per FDA Process Validation Guidance and ICH Q7 – plus change control in operation.

Regulatory framework: Annex 15, Annex 11, GAMP 5 and more

The Validation Manager role rests on the frameworks that define scope and depth of evidence:

EU GMP Annex 15: validation master plan, risk-based qualification, documented deviation assessment and continued process verification.
EU GMP Annex 11: computerised system lifecycle, supplier assessment, change control and periodic review.
ISPE GAMP 5, 2nd Edition: software categories, risk-based test scope and SDLC evidence – especially for categories 4 and 5.
21 CFR Part 11: electronic records and signatures where US markets or global harmonisation apply.
FDA Process Validation Guidance and ICH Q7: process validation for finished dosage forms and active substance manufacture.

FAQ on the Validation Manager

What are the core duties of a Validation Manager?

The Validation Manager writes the validation master plan, leads the risk analyses, sets the scope and depth of testing, steers the execution of protocols and assesses deviations. They are accountable for a complete and internally consistent body of evidence at the end of the project.

What is the difference between qualification and validation?

Qualification applies to equipment, instruments and rooms and demonstrates that they are fit for the intended purpose. Validation applies to processes and computerised systems and demonstrates that they reproducibly deliver the required result. Annex 15 treats both within one common framework.

Can a Validation Manager help at short notice before an audit?

Yes. The useful step is a review of the validation file: completeness of signatures, open deviations, traceability of test results and whether periodic reviews are current. Anything that can no longer be evidenced we document openly with an action and a date rather than concealing it.

How long does support from an external Validation Manager last?

That depends on scope. A targeted equipment qualification takes a few weeks; a system rollout across several sites takes several months. On new build projects we stay for the full project duration, usually with a decreasing share after go-live.