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Computer System Validation (CSV)

Validate your systems with confidence and protect data integrity

BioBoston provides end-to-end Computer System Validation (CSV) support so your electronic systems perform as intended, maintain data integrity, and meet FDA/EMA expectations especially for 21 CFR Part 11 and GAMP 5-aligned validation.

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  • 21 CFR Part 11 and GAMP 5 expertise

  • Risk-based validation for the right level of effort

  • Clear documentation for audits and inspections

  • Flexible support for new systems or remediation

Who this is for

This service is a fit if

  • You’re implementing a new system (EDC, LIMS, QMS, ERP, MES, LMS, etc.)
  • You need to remediate gaps before an audit, inspection, or customer assessment
  • Your validation documentation is incomplete or inconsistent
  • You need stronger Part 11 controls, audit trails, and access management evidence
  • You want a practical validation approach that matches risk and business criticality

What you’ll get

  • You will receive audit-ready CSV deliverables such as:
  • Validation plan and strategy aligned to system risk and intended use
  • Risk assessment and traceability approach to justify validation depth
  • IQ/OQ/PQ (or lifecycle validation equivalents) executed with documented evidence
  • Part 11 and data integrity assessment support (security, audit trails, electronic records)
  • Change control and revalidation approach to keep systems compliant over time
  • Complete validation package: protocols, scripts, traceability matrix, and summary report

What we do

Our CSV support can include:

  • CSV planning and protocol development

  • Risk-based validation approach (system criticality and impact)

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Data integrity and security validation (including 21 CFR Part 11 controls)

  • Change control and revalidation support

  • CSV documentation and reporting (protocols, scripts, traceability, summary reports)

Why BioBoston

  • CSV succeeds when it’s clear, defensible, and proportional to risk.
  • We help you avoid over-validating low-risk features while ensuring high-risk functions are fully supported with evidence. The result is a validation package that stands up during audits and inspections and a system you can rely on operationally.

Validation plan + risk strategy

We define the right lifecycle approach, deliverables, and testing scope based on risk.

Execute + document

We run testing, collect evidence, and deliver a complete validation package ready for review and inspection.

Discovery call

We confirm your system, intended use, validation status, timelines, and audit/inspection drivers.

How it works

Frequently Asked Questions

We use a risk-based approach tied to intended use, data impact, patient impact, and regulatory expectations.

Yes. We can assess gaps, define a remediation plan, and build the missing documentation and evidence.

Yes. We assess and document key controls like access management, audit trails, electronic records/signatures (as applicable), and data integrity safeguards.

Get a compliant validation package without unnecessary rework

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