ITART Consulting
Practice 2 · Pharma & Life Sciences

Computer Systems Validation

We build and keep your GxP systems validated and audit-ready, so your business can move at the speed of innovation, not the speed of paperwork.

  • GAMP 5
  • 21 CFR Part 11
  • EU Annex 11
  • With Validfor
  1. 1CSV / CSA
  2. 2Qualification (CQV)
  3. 3Validfor VLM Platform
  4. 4CSV Project Management
  5. 5Training
  6. 6Outsourcing
1

CSV / CSA: System Validation & Software Assurance

Computer system validation and computer software assurance across your company.

  • Validation documentation: plans, protocols and reports
  • CSV / CSA for ERP (SAP S/4HANA, Oracle), LIMS, MES, QMS and cloud SaaS
  • Data integrity gap analysis against 21 CFR Part 11 and EU Annex 11, with remediation
  • Risk-based approach that focuses effort where patient and product risk is real
2

Qualification & Commissioning (CQV)

End-to-end equipment and facility qualification.

  • Commissioning and qualification of production and laboratory equipment
  • Utilities and water systems, including HVAC filter-integrity testing
  • Controlled qualification of BMS, WMS and network systems
  • Data integrity assessment across qualified GxP systems
3

Validfor VLM: Agentic AI Validation Platform

An AI-native digital validation platform that cuts validation timelines from months to days.

  • AI-assisted requirement generation and design control
  • AI-generated and automated test-script execution
  • Automated deviation and change capture, impact assessment and resolution
  • Scheduled periodic reviews and audit-ready document control
  • Validation packages with electronic signatures and immutable audit trails
4

CSV Project Management

Management and governance of validation projects, from strategy to audit readiness.

  • Validation and qualification strategy and planning
  • Risk assessment under GAMP 5 and MHRA GMP data integrity guidance
  • Supplier and vendor compliance assessment
  • Audit remediation and GxP audit-readiness checks
5

Training

Tailored training that leaves your teams able to do it themselves.

  • Computer Software Assurance and the critical-thinking approach
  • CSV under GAMP 5 and MHRA GMP data integrity
  • 21 CFR Part 11, EU Annex 11, IT compliance and data integrity
  • Cloud systems in GxP processes and their validation
  • Hands-on Excel validation and deviation management
6

Outsourcing

Flexible resource augmentation and project outsourcing.

  • Access to a network of 60+ CSV, CSA and CQV specialists
  • CSV / CSA delivery as a managed service
  • Managed periodic review for ongoing lifecycle compliance, delivered remotely

Let's Get Started

Tell us about the programme, the validation or the process you want to hand to AI. We reply within one working day.

Get in touch Company brochure
Email
info@itart.ch
Office
Basel, Switzerland