Service 04 · CSV

Computer system validation

Risk-based validation support for the computerized systems that create, manage, or report your GMP records — from standalone instrument software to cloud applications.

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What this covers

Validation planning

System inventory, GxP impact assessment, and validation plans.

Requirements & risk

User requirements and risk assessments following GAMP 5 principles.

Supplier assessment

Review of vendor documentation and controls, especially for SaaS and cloud systems.

Testing

Test scripts, execution, and summary reports, with effort scaled to risk.

Data integrity & Part 11 considerations

Audit trails, access controls, and electronic records and signatures review.

Periodic review & change control

Keeping validated systems in a validated state as they change.

When teams call us

  • A new LIMS, MES, eQMS, BMS, or EMS is being implemented
  • Instrument or application software is being upgraded
  • A data-integrity observation needs follow-up
  • A SaaS vendor or configuration is changing
  • Periodic reviews have fallen behind

What you receive

  • Validation plan
  • URS and risk assessments
  • Test protocols and executed evidence
  • Traceability matrix
  • Validation summary report
  • Periodic review template

How an engagement runs

  1. Scope

    A short conversation about your facility, systems, timeline, and what your quality team needs to see.

  2. Plan

    A written scope, method, and deliverables list, aligned with your SOPs and templates where they exist.

  3. Execute

    On-site work with deviations raised as they happen — not after.

  4. Document & hand over

    Reports and records formatted for your QA review and approval.

Standards we reference

  • GAMP 5 (2nd ed.)
  • 21 CFR Part 11
  • EU GMP Annex 11
  • FDA CSA guidance

References describe the methods we plan against; they don't imply endorsement or certification by any standards body.

Quantex Bioservices provides technical services and documentation support. Acceptance decisions remain with your quality unit. Information on this site is general and is not regulatory or legal advice.

FAQ

Do we need to validate everything the same way?

No. A risk-based approach focuses effort where the impact on product quality and data integrity is highest.

Can you validate cloud / SaaS systems?

Yes. We combine supplier assessment with verification of your configuration and intended use.

Will you work with our IT team?

Yes. CSV works best with IT, QA, and system owners at the same table.

Often paired with

CQV & engineering

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Cleanroom testing

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Planning a new suite, an expansion, or a recurring test program?

Tell us what you're working on. We'll reply with a few questions, a suggested scope, and next steps.

Talk about a CSV scope