Computer system validation & quality
Validated systems.
Audit-ready evidence.
VariTec plans and executes computer system validation as per 21 CFR Part 11, EU Annex 11 and GAMP 5, using a risk-based approach including Computer Software Assurance (CSA).
Validation lifecycle
- PART 11 · ANNEX 11 · GAMP 5
01
Plan
VMP, risk classification, CSA approach
02
Execute
Requirements, IQ / OQ / PQ, Part 11 and Annex 11
03
Sustain
Release validation, periodic review, audit
- CSV
- CSA
- IQ / OQ / PQ
- Data integrity
- SOPs
- Traceability matrix
- Inspection readiness
Validation built in: every change assessed before it reaches production.
- Problems we solve
Every release needs validation. Teams are stretched.
Documentation falls behind, periodic reviews are missed and audits find gaps.
- Workload
Too many releases, too few validators
New systems, upgrades and vendor releases arrive faster than QA can validate them.
- Evidence
Documentation gaps
Missing or outdated validation records create audit findings.
- Approach
Script-heavy validation
Traditional methods take too long for today’s release cycles.
- Systems we validate
Validation for the systems that run pharmaceutical operations.
From packaging lines to enterprise applications and the infrastructure underneath.
- ERP / WMS
ERP and warehouse applications
SAP, Ross and Syspro ERP, and warehouse management.
- Manufacturing
Manufacturing and packaging equipment
Computerised machines and equipment on manufacturing sites.
- IT
IT infrastructure and cloud
Servers, networks and cloud platforms that host validated applications.
- What we deliver
Validation from plan to audit.
- CSV
- CSA
- 21 CFR Part 11
- EU Annex 11
- GAMP 5
- IQ / OQ / PQ
- 01 · Plan
Validation strategy and planning
Validation master plans, risk classification and the right approach for each system.
- 02 · Execute
Validation execution
Requirements, risk assessments, IQ, OQ and PQ protocols, deviation handling, summary reports, and Part 11 and Annex 11 assessments.
- 03 · Sustain
Change validation and periodic review
Release and change validation, periodic reviews, SOPs and traceability, so systems stay in a validated state.
- 04 · Audit
System audits and health checks
Individual system audits, health and process checks, and inspection readiness.
- 05 · Modernise
Moving from CSV to CSA
Adopt Computer Software Assurance: risk-based testing that focuses effort where it matters and cuts documentation.
- Deliverables
Documents you receive
Every engagement produces complete, inspection-ready documentation.
DELIVERABLES
- Validation Master Plan
- URS
- FRS
- Risk assessment
- IQ / OQ / PQ protocols
- Traceability matrix
- Validation summary report
- SOPs
- Outcomes
Quality you can show an auditor.
Validation specialists who also understand the systems being validated.
- Compliance
Inspection-ready records
Complete, current evidence for every validated system.
- Speed
Validation that keeps pace
Risk-based effort, so releases are not delayed.
- Confidence
One team for build and validation
Implementation and validation delivered together.