Computer Systems Validation
We build and keep your GxP systems validated and audit-ready, so your business can move at the speed of innovation
CSV / CSA — System Validation & Software Assurance
Comprehensive computer system validation and computer software assurance across your company.
- Validation Documentation — comprehensive plans, protocols, and reports.
- Enterprise System Validation — CSV/CSA for ERP (SAP S/4HANA, Oracle), LIMS, MES, QMS, and cloud SaaS.
- Data Integrity Gap Analysis — 21 CFR Part 11 and EU Annex 11 assessment and remediation.
Qualification & Commissioning (CQV)
End-to-end equipment and facility qualification services.
- Equipment Qualification — commissioning and qualification of production and laboratory equipment.
- Utilities & Water Systems Qualification — including HVAC filter-integrity testing.
- BMS/WMS & Network Qualification — controlled qualification of building, warehouse, and network systems.
- Data Integrity Gap Analysis — integrity assessment across qualified GxP systems.
Validfor VLM — Agentic AI Digital Validation Platform
Our agentic AI digital validation platform streamlines validation workflows and compliance for faster, more efficient project delivery.
- Requirement & Design Management — AI-assisted requirement generation and design control.
- Test Management — AI-generated and automated test-script execution.
- Deviation & Change Management — automated capture, impact assessment, and resolution.
- Periodic Review & Repository — scheduled reviews and secure, audit-ready document control.
- Validation Package Generation — audit-ready packages with electronic signatures and immutable audit trails.
Training
Customized training solutions to upskill your teams.
- Computer Software Assurance Training — CSA and the critical-thinking approach.
- CSV Training — under the scope of GAMP 5 and MHRA GMP data integrity.
- Regulatory Compliance Training — 21 CFR Part 11 / EU Annex 11, IT compliance, and data integrity.
- Cloud & GxP Systems Training — cloud systems in GxP processes and validation.
- Excel Validation & Deviation Management Training — practical, hands-on enablement for your teams.
Outsourcing
Flexible resource augmentation and project outsourcing.
- Resource Augmentation — access to a 60+ expert network of CSV, CSA, and CQV specialists.
- CSV / CSA Delivery — computerized system validation and software assurance execution.
- Managed Periodic Review — ongoing lifecycle compliance, delivered remotely 24/7.
CSV Project Management
End-to-end management and governance of validation projects — from strategy through audit readiness.
- Validation Strategy & Planning — validation and qualification strategy development.
- Risk Assessment — risk-based validation under GAMP 5 and MHRA GMP data integrity.
- Supplier Assessment — evaluation of supplier and vendor compliance.
- Audit Remediation — IT/QA support and GxP audit-readiness checks.