Requirements & Planning
URS, system scope, validation planning, intended use, roles and lifecycle strategy.
Computer System Validation
Validation for pharmaceutical and regulated computerized systems.
Risk-based CSV support focused on intended use, patient and product risk, data integrity, traceability and documented evidence throughout the system lifecycle.
CSV capability
From requirements to documented verification.
We help organizations structure Computer System Validation activities for systems used in regulated environments. The emphasis is on clear requirements, appropriate risk controls and objective evidence that the system performs as intended.
GAMP 521 CFR Part 11ALCOA+Data IntegrityRisk-Based CSV
Designed for regulated environments
CSV is not only about documents. It is about connecting intended use, risk, access, records, testing, traceability and lifecycle control so the organization can defend the reliability of the computerized system.
Validation lifecycle
Documents and activities we can support.
Risk Assessment
GxP impact, data integrity risk, functional risk and testing priorities based on criticality.
Design & Traceability
Design review, DQ where applicable, requirements traceability and test coverage mapping.
IQ / OQ / PQ
Installation, operational and performance qualification with predefined acceptance criteria and documented evidence.
Part 11 & Data Integrity
User access, audit trails, electronic records, password controls, time settings, backup, restore and ALCOA+ considerations.
Lifecycle Controls
Change control, periodic review, incident handling, backup and recovery, decommissioning and validation maintenance.
Systems we can support
CSV across business and laboratory technology.
ERP / SAPLIMSBMS / EMSLaboratory SoftwareProduction SystemsElectronic RecordsCustom GxP ApplicationsSpreadsheets where applicable
Preparing a new system for validation or closing CSV gaps?
We can help structure the requirements, risk assessment, testing and traceability needed for a defendable validation package.