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Services/Qualification and validation (CQV)

Commissioning · Qualification · Validation

Qualification and validation (CQV) for production systems and equipment

Qualification of new or modified production and laboratory equipment, including periodic assessment and requalification.
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All services at a glance
Two specialists checking a sensor at pharmaceutical production equipment and comparing the results on a tablet

Services at a glance

Qualification and validation for production systems and equipment.

All services are directly visible. The specific scope follows from the project context, risks and existing documentation.
Core serviceProduction equipment

Qualify production systems and equipment using a risk-based approach

Direct technical support from user requirements and qualification strategy through DQ, IQ, OQ and PQ to a traceable final report.

Typical starting pointsNew equipment · Process change · Change Control · Limited resources
Possible deliverable

An agreed, risk-based qualification package with clear responsibilities, a traceable scope, documented test results, assessed deviations and a qualification report.

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Core serviceLaboratory equipment

Qualify laboratory equipment using a risk-based approach

From defining the risk-based qualification scope through the required testing and deviation assessments to the qualification report.

Typical starting pointsNew laboratory equipment · Requalification · Documentation gap
Possible deliverable

An agreed qualification package with traceable requirements, defined acceptance criteria, documented test results, assessed deviations and a qualification report.

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Core servicePeriodic assessment

Assess and maintain the qualified state of production systems and equipment with traceable evidence

QMVP assesses changes and existing evidence, derives a risk-based scope and supports periodic assessments, requalification and revalidation.

Typical starting pointsRequalification · Upcoming audit · Change Control · Documentation gap
Possible deliverable

A traceable status assessment with a gap list, risk-based assessment or requalification scope, defined actions and updated qualification evidence.

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Core serviceTemperature-controlled systems

Qualify temperature-controlled systems and areas using a risk-based approach

From refrigerators and freezers to incubators, environmental chambers and temperature-controlled storage and production areas: QMVP supports temperature mapping, sensor placement, data analysis, deviation assessment and qualification documentation.

Typical starting pointsNew equipment · Requalification · Change Control · Deviation
Possible deliverable

An agreed qualification package with defined operating and loading conditions, justified sensor positions, acceptance criteria and traceable documentation of results and deviations.

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Additional service modules

When planning, review or closure determines the next step.

These project modules apply where strategy, planning, review or closure determines the specific scope of support.Discuss the right scope

Strategy & scope

Define a risk-based qualification scope before unnecessary tests and rework arise

QMVP derives an appropriate scope of DQ, IQ, OQ and PQ qualification and testing from the URS, risk assessment and preceding specifications.
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Project planning

Clear planning for your validation project

QMVP works with you to prepare a risk-based Validation Master Plan (VMP) as a clear, practical basis for your validation and qualification project.
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Technical document review

Review validation and qualification documents before an audit or inspection

Receive a traceable gap list, direct technical feedback and targeted corrective actions for the remaining preparation time.
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Processes & templates

Make validation processes and templates lean, consistent and risk-based

QMVP reviews existing validation processes and controlled document templates, reduces unnecessary complexity and aligns scope and detail with the relevant system risks.
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Qualification conclusion

Close CQV projects with structure and traceability

QMVP consolidates test results, deviations and open points in a traceable qualification report.
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Project closure

Review validation documentation and prepare project closure

QMVP reviews existing documents, records gaps and outstanding assessments and supports completion of the required validation evidence.
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Collaboration and boundaries

Technical support with clear operator and approval responsibilities.

Scope, interfaces, deliverables and decisions are agreed transparently before delivery begins.

QMVP supports you with

  • Scope, requirements, risks and acceptance criteria
  • Agreed qualification, review and documentation tasks
  • Assessment of results, deviations and open points

Next step

Discuss your qualification needs together.

In our first discussion, we clarify the project situation, existing evidence, responsibilities and the desired deliverables.Discuss your project