About QMVP

From Strategy to Implementation

QMVP combines regulatory expertise with practical project work. We bring structure to complex requirements and turn them into clear approaches, reliable documentation and solutions that work in practice.

Discuss your project Explore our services

Project deliveryRemote and hybrid work across borders. Targeted on-site support according to project needs.Project languagesGerman · English

What QMVP stands for

Direct expertise that moves projects forward.

At QMVP, you work directly with experienced specialists. We assess complex requirements, clarify priorities and translate them into concrete work packages and usable results.

Short communication paths and the combination of technical advice and practical delivery support decisions and reliable project progress.

CSV/CSA · CQV for production systems & equipment · Quality management

The team behind QMVP

The technical context stays connected.

From the first discussion, dedicated contacts accompany your project. Background, considerations and agreements remain present throughout its lifecycle.

CEO & Consultant

M. Sc. Eugen Betche

Eugen combines extensive experience in quality management and quality assurance with production equipment and laboratory instrument qualification, CSV, data integrity, and process and method validation. He structures complex requirements and risks, coordinates the technical interfaces involved and brings qualification and validation projects to traceable conclusions.

QM/QA · CQV · CSV/CSA
Qualification and validation
Risk-based testing · Documentation

LinkedIn profile

Co-Founder & Consultant

Dr.-Ing. Franz Müller

Franz combines scientific and technical analysis and industrial process development with CQV and CSV/CSA. He applies his experience to structuring requirements and risks, risk-based testing, traceability, data integrity and traceable validation documentation.

QM/QA · CQV · CSV/CSA
Qualification and validation
Risk-based testing · Documentation

LinkedIn profile

From practical project experience

Experience that informs our work today.

QMVP draws on experience from earlier validation, qualification and CSV projects. The following examples illustrate typical assignments and contributions.

Specialists reviewing a laboratory analytical system in a pharmaceutical quality control laboratory

CQV + CSV

New or modernized laboratory analytical systems require equipment qualification, CSV, method transfer, IT integration and data integrity to work together. Our experience includes planning and supporting IQ, OQ and PQ, handling deviations, and managing traceability, SOPs, training and controlled operational handover.

Areas of experience

Coordinated planning of CSV, qualification and method transfer
Traceability between requirements, risks and tests
Coordination of laboratory, quality assurance, IT and suppliers

Specialists assessing a computerized system at pharmaceutical production equipment

CSV + DATA INTEGRITY

For new or substantially modified production equipment, computerized systems, interfaces and data flows are assessed early using a risk-based approach. Our experience spans risk assessments and appropriate measures, reviews and deviation management through status tracking, reporting and project closure.

Areas of experience

Risk assessments for computerized systems and data integrity
Structured tracking of actions, deadlines and deviations
Coordination of engineering, quality assurance, digital/IT and suppliers

Specialists comparing qualification documents at pharmaceutical production equipment

CQV + COMPLIANCE

Where operators, suppliers and several technical functions contribute to qualification, documents, tests and approvals must remain consistent. Our experience includes technical review of URS, DQ, VMP, risk assessments and IQ, OQ and PQ documents, as well as structured management of open points.

Areas of experience

Technical review of qualification and supplier documents
Traceability between requirements, risks and test evidence
Structured tracking of document status, deviations and approvals

Project example 1 of 3: Laboratory & analytics

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Qualify and validate laboratory analytical systems and transfer them into operation

Coordinated planning of CSV, qualification and method transfer
Traceability between requirements, risks and tests
Coordination of laboratory, quality assurance, IT and suppliers

Integrate CSV and data integrity into production projects from the start

Risk assessments for computerized systems and data integrity
Structured tracking of actions, deadlines and deviations
Coordination of engineering, quality assurance, digital/IT and suppliers

Coordinate qualification evidence across supplier interfaces

Technical review of qualification and supplier documents
Traceability between requirements, risks and test evidence
Structured tracking of document status, deviations and approvals

How we work

How our work makes a difference.

The agreed scope becomes visible in everyday project work: clear decisions, reliable responsibilities and documents you can use directly.

Direct expertise

Questions and necessary adjustments are discussed with the assigned specialists, avoiding unnecessary handovers.

Across interfaces

CQV, CSV/CSA and quality management are considered together where equipment, systems and evidence meet.

From need to result

Requirements become defined tasks, responsibilities and deliverables such as plans, assessments, traceability and reports.

Discuss your project

What does your project involve?

Outline your current situation, project objective and open points. This helps us assess your inquiry and prepare the next practical discussion.

Direct contact

info@qmvp.de +49 6032 9910160

Frankfurter Straße 56
61231 Bad Nauheim, Germany

You can also contact us directly by email or phone with the project information available to you.

From Strategy to Implementation

Direct expertise that moves projects forward.

The technical context stays connected.

CQV and CSV in the laboratoryQualify and validate laboratory analytical systems and transfer them into operationShow details

CSV and data integrity in equipment projectsIntegrate CSV and data integrity into production projects from the startShow details

CQV and complianceCoordinate qualification evidence across supplier interfacesShow details

Direct expertise

Across interfaces

From need to result

What does your project involve?