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Computer system validation · GAMP 5 · Pharma, biotech, medtech

Risk-based validation for GxP systems

CSV for pharma, biotech and medtech, across the entire system lifecycle.

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Typical starting points

  • New system or upgrade

    SAP S/4HANA, a LIMS or a software tool: validation should run with the project instead of holding up go-live at the end.

  • Implementation with a partner

    You need someone on your side who steers and assesses the integrator's testing and validation.

  • Effort out of line with risk

    Lots of paper in some places, too little solid evidence in others.

  • Changes take too long

    Every change is treated like a small revalidation.

  • An inspection is coming

    You want to know whether your evidence will hold.

  • Building up or short-handed

    There's no CSV function or test process yet, or the lead role is vacant.

Services

  • Business Process Analysis
  • Requirements Engineering
  • Risk Management
  • Supplier Qualification
  • Testing
  • Infrastructure Qualification
  • Security
  • Data Governance
Computer system validation at a glance: the disciplines that together make a validated system.

  • Computer system validation

    Risk-based validation across the lifecycle, following GAMP 5 principles and focused on patient safety, product quality and data integrity.

    • Validation plan
    • Risk assessment
    • Requirements
    • Traceability
    • Test evidence
    • Validation report
    • CSA

  • Testing and validation on the client side

    When a partner implements your system, such as an ERP or LIMS, I steer testing and validation from your side and assess the integrator's deliverables.

    • Test strategy
    • Master Test Plan
    • Test coordination
    • Defect management
    • Supplier documentation

  • Change control and release management

    An impact assessment sets the test scope for each change, instead of retesting every release from scratch.

    • Change control process
    • Impact assessment
    • Regression strategy
    • Periodic review

  • Inspection readiness

    I review your evidence before the inspection and show where the gaps are and how to close or justify them.

    • Gap assessment
    • Action plan
    • Preparing for inspector questions

  • Independent review

    A second, critical look at your validation deliverables, with specific findings rather than general remarks.

    • Plans
    • Risk assessments
    • Test scripts
    • Traceability matrices
    • Reports

  • Interim lead and build-up

    I lead your validation or test workstream for a defined period, or build a CSV function or test process with your team.

    • Interim CSV Lead
    • Interim Test Manager
    • Process build-up
    • Handover

How I work

  • Risk-based

    Effort follows the risk to patient, product and data, not a template.

  • Alongside the project

    Validation and testing run with the project, not after it.

  • Use what exists

    Supplier documentation and existing tests are used where they hold up.

  • Handover to your team

    You get the documents, the decisions and the reasoning, enough to carry on yourselves.

Project phase

  1. Understand the process and requirements
  2. Assess the risks
  3. Define the controls
  4. Verify and release

Operation phase

  1. Assess and control changes
  2. Plan and test releases
  3. Review periodically

Background

Portrait of Benjamin Burk
Benjamin Burk Senior Consultant for CSV and Test Management
  • 15+ yearsin regulated environments: pharma, biotech, diagnostics, medical devices
  • Co-authorin the ISPE GAMP Good Practice Guide: Testing GxP Systems (3rd Edition)
  • From ERP to software toolsa range of GxP systems validated and tested
  • ISTQBCertified Tester

Selected projects

  • Established a company-wide test management process for SAP S/4HANA, including the first comprehensive Master Test Plan, and co-led the CSV workstream for SAP S/4HANA and SAP Solution Manager.
  • Led an inspection readiness project for an SAP S/4HANA landscape.
  • Delivered validation for a global LIMS implementation.
  • Established risk-based software validation and built a three-person CSV team at a health technology company.
  • Piloted agentic AI tooling in validation work.

Contact

Every engagement starts with a conversation.

Listen first, then assess

  1. You describe your situation in 20 minutes. I listen and ask questions.
  2. Afterwards I analyse what you've told me.
  3. You receive a short written assessment: where I would start and how I can support you.

The call and the assessment are free and without obligation.

Book a free introductory call

Please don't send confidential documents for the introductory call.