Computer System Validation
Risk-based validation services for computerized systems used in regulated environments.
A structured lifecycle built around requirements, risk and evidence.
Requirements
Define intended use, business needs and system requirements.
Supplier Assessment
Assess supplier capabilities and relevant quality and support information.
Risk Assessment
Identify risks and determine appropriate controls and testing depth.
Validation Plan
Define scope, responsibilities, approach, deliverables and acceptance.
Specifications
Develop appropriate functional, design or configuration documentation.
Qualification & Testing
Execute IQ, OQ, PQ or appropriate verification activities.
Traceability
Demonstrate coverage from requirements through testing.
Summary & Review
Document validation status and support continued validated state.
The same disciplined lifecycle, every time.
Each engagement follows a consistent, risk-based lifecycle so validation status stays clear, defensible and easy to hand over to your quality team.
Validation designed with regulated environments in mind.
GAMP 5
Apply a risk-based approach appropriate to computerized systems.
21 CFR Part 11
Address applicable electronic records and electronic signatures expectations.
EU Annex 11
Consider computerized-system controls for regulated operations.
ALCOA+
Support data integrity principles through appropriate controls and evidence.
Documented evidence, not just a checklist.
Every engagement produces the documentation your quality and audit teams actually need to rely on.
User Requirements Specification
A clear statement of intended use and business requirements.
Risk Assessment Report
Documented risk ranking used to scope testing depth.
Validation Plan
Scope, responsibilities, approach and acceptance criteria.
IQ / OQ / PQ Scripts
Executed, reviewed test scripts with objective evidence.
Requirements Traceability Matrix
Coverage from each requirement through to a test result.
Validation Summary Report
A single document confirming validated status and any open items.
Change control and periodic review keep a system in its validated state through upgrades, patches and configuration changes — not just at initial deployment.