Too many releases, too few validators
New systems, upgrades and vendor releases arrive faster than QA can validate them.
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).
Problems we solve
Every release needs validation. Teams are stretched.
Documentation falls behind, periodic reviews are missed and audits find gaps.
Documentation gaps
Missing or outdated validation records create audit findings.
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.
Serialization
Manufacturing
IT
Serialization systems
Line, site, enterprise and reporting systems, L1 to L5.
Serialization → ERP / WMSERP and warehouse applications
SAP, Ross and Syspro ERP, and warehouse management.
ERP / WMS → EDIEDI and integrations
Partner transactions, interfaces and data flows between systems.
EDI →Manufacturing and packaging equipment
Computerised machines and equipment on manufacturing sites.
IT infrastructure and cloud
Servers, networks and cloud platforms that host validated applications.
IT & Cloud →What we deliver
Validation from plan to audit.
CSVCSA21 CFR Part 11EU Annex 11GAMP 5IQ / OQ / PQ
Validation strategy and planning
Validation master plans, risk classification and the right approach for each system.
Validation execution
Requirements, risk assessments, IQ, OQ and PQ protocols, deviation handling, summary reports, and Part 11 and Annex 11 assessments.
Change validation and periodic review
Release and change validation, periodic reviews, SOPs and traceability, so systems stay in a validated state.
System audits and health checks
Individual system audits, health and process checks, and inspection readiness.
Audits and readiness →Moving from CSV to CSA
Adopt Computer Software Assurance: risk-based testing that focuses effort where it matters and cuts documentation.
Documents you receive
Every engagement produces complete, inspection-ready documentation.
See deliverables →DELIVERABLESValidation Master PlanURSFRSRisk assessmentIQ / OQ / PQ protocolsTraceability matrixValidation summary reportSOPs
Outcomes
Quality you can show an auditor.
Validation specialists who also understand the systems being validated.
Inspection-ready records
Complete, current evidence for every validated system.
Validation that keeps pace
Risk-based effort, so releases are not delayed.
One team for build and validation
Implementation and validation delivered together.