Practice 03

Validation, CQV & Computer Systems (CSV/CSA)

We validate the facilities, equipment, processes, and computer systems your product depends on — from commissioning and qualification through CSV/CSA — with documentation that stands up to inspection.

All servicesOverview

Validation is where compliance meets the plant floor. Our CQV and CSV/CSA specialists take facilities from design qualification through process validation and computer system assurance — writing protocols that pass, executing them cleanly, and leaving a documentation trail that holds under any audit. We work greenfield builds, tech transfers, and legacy remediation alike.

IQ/OQ/PQ

Equipment & process validation

CSV / CSA

Computer system assurance

Greenfield

To licensure, end to end

Validation, CQV & Computer Systems (CSV/CSA)
What we do

How we help

Facility, equipment, process, and computer system validation — from greenfield builds to data integrity.

Commissioning & Qualification

C&Q for facilities, utilities, and equipment, from URS through PQ.

Process Validation

Stage 1–3 process validation and continued process verification.

Computer System Validation (CSV)

GAMP 5 validation for GxP computerized systems and Part 11 compliance.

Computer Software Assurance (CSA)

Risk-based CSA that cuts paperwork and focuses effort where it matters.

Facility & Utility Validation

Cleanrooms, HVAC, water systems, and utilities from design through PQ.

Validation Remediation

Legacy system and equipment revalidation and documentation remediation.

How we work

A clear path, start to finish.

01

Plan

Validation master plan, risk assessment, and requirements.

02

Qualify

Commissioning, IQ/OQ/PQ, and CSV/CSA protocol execution.

03

Verify

Process validation, data integrity, and documentation review.

04

Sustain

Periodic review and a validated state that stays that way.

Talent we provide

The people behind the work.

Vetted, screened, and matched to your exact needs — on a contract, interim, or permanent basis.

CQV EngineersCSV / CSA SpecialistsAutomation & Controls Validation EngineersProcess Validation EngineersCommissioning & Qualification LeadsData Integrity Specialists
Certifications & standards

Held to the highest bar.

We work to the standards your regulators, auditors, and customers expect.

GAMP 5ISPE Baseline Guides21 CFR Part 11IQ/OQ/PQASTM E2500Six Sigma / Lean
Where we apply it

Industries this practice serves

Let’s talk about validation, cqv & computer systems (csv/csa).

Tell us what you’re working on and we’ll show you how this practice can help.