CSV · CSA · System lifecycle

Computerized system and software validation (CSV/CSA)

Risk-based validation of new or modified computerized systems, including periodic review and revalidation.

Discuss your project Explore core services

Three specialists reviewing traceability and validation evidence for a computerized system

Services at a glance

Validation across the entire system lifecycle.

All services are directly visible. System boundaries, GxP relevance, risks and required evidence follow from the specific intended use.

Core serviceCSV & CSA

Validate computerized systems using a risk-based approach

QMVP supports risk-based computerized system validation – from validation strategy and user requirements through risk-based testing and traceability to the validation report.

Typical starting pointsNew system · Process change · Change Control · Documentation gap

Possible deliverable

A proportionate validation package with agreed requirements, responsibilities, controls, risk-based validation tests, traceability and a validation report – suited to the regulatory environment and the application's actual use.

Discuss validation needs

Core servicePeriodic Review

Assess the validated state of computerized systems through periodic review

QMVP assesses changes, deviations, incidents, access rights, data integrity and operational and supplier evidence to establish a traceable basis for required actions or revalidation.

Typical starting pointsPeriodic Review · Upcoming audit · CAPA / Finding · Documentation gap

Possible deliverable

A periodic review report with a traceable assessment of the continuing validated state, a gap list and a prioritized action or revalidation plan.

Discuss validation needs

Core serviceData integrity & audit trails

Review data integrity, access rights and audit trails using a risk-based approach

QMVP assesses GxP-relevant data flows, roles and access rights, audit trail functions and review processes using a risk-based approach and documents unmet requirements and required actions.

Typical starting pointsUpcoming audit · Regulatory inspection · CAPA / Finding · Documentation gap

Possible deliverable

A traceable gap assessment with clear responsibilities, applicable review criteria and a prioritized action plan for data integrity, access rights and audit trail controls.

Assess audit readiness

Core serviceSaaS & Cloud

Validate SaaS and cloud applications using a risk-based approach across the system lifecycle

QMVP helps define operator and service provider responsibilities and assess supplier evidence, changes, releases and required revalidation activities using a risk-based approach.

Typical starting pointsNew system · Change Control · Client audit · Documentation gap

Possible deliverable

A usable validation package with clear operator and service provider responsibilities and a risk-based approach to supplier evidence, testing, traceability, changes, releases and revalidation.

Discuss validation needs

Further areas of support

When data integrity, cloud responsibilities or the validation process itself needs attention.

These project modules address specific system and project risks within the agreed scope.Discuss the right scope

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.

Request a documentation review

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.

Discuss your project

Collaboration and boundaries

Risk-based validation with clear operator and approval responsibilities.

System boundaries, roles, evidence and decisions are clearly defined before delivery begins.

QMVP supports you with

Assessment of system and GxP relevance, system boundaries and risks
Agreed user requirements, testing, traceability and review tasks
Assessment of changes, evidence and required revalidation activities

Next step

Discuss your validation needs together.

In our first discussion, we clarify system use, lifecycle phase, existing evidence, responsibilities and the desired deliverables.Discuss your project