Computer System Validation

Why Computer System Validation?

Production processes, lab equipment & systems, ERP systems, Quality systems, etc. that are being managed or supported by a computer system have to comply with strict rules with regards to continuity, reliability and data integrity. Computer System Validation provides producers of pharmaceutical products (a.o.) with the documented proof that the computerized/automated system performs consistently and in compliance with all regulations involved. Agidens delivers CSV advice and support to companies in the Life Sciences sector

CSV: what and how?

Automated production processes are being managed or controlled by a PLC or computerized system. Validation of these systems is a crucial part of the System Development Life Cycle (SDLC). If not validated, deviations (between the business or regulatory requirements and the delivered solution) might arise in a later project phase. Validation delivers a documented proof that the system complies with the specifications during the entire life cycle.

USA FDA  21 CFR Part 210, 211 and 11 and EU GMP Volume 4 Annex 11 describe the requirements for computerized systems in medicine production processes. These regulations apply to every computerized system that generates data that is used to support quality decisions or that is used to report to FDA.

GAMP5© serves as a guideline to execute CSV in a thorough and structured manner. GAMP stands for Good Automated Manufacturing Practices and offers a series of procedures and principles which allows companies that produce pharmaceutical products to assure quality levels in a continued way. This is possible by validating all phases in the production process. It goes from the screening of raw materials to the training of operators, and it includes of course the validation of the software and equipment used. Gamp5© describes a.o.:
  • A risk based approach for compliant GxP computerized systems
  • Archiving methods of electronic GxP critical data
  • Management and qualification of IT infrastructure
  • Testing of GxP systems
  • Etc.

Why Agidens?

  • Our Experts offer support for Computer System Validation (CSV) in compliance with the current GxP/ISO directives and norms.
  • Qualification approach is based on GAMP5© and the Life Cycle model (V-model)

Depending on the requirements of the customer and the complexity of the project, we deliver customized solutions (local assistance) or standard solutions (package, fixed price).

Data integrity

The current focus on data integrity by the inspecting authorities leads to many actions in the field of computerized systems at different companies. Agidens supports this by conducting trainings, gap assessments and impact assessments.

ISO 13485

The most recent version of ISO 13485 focuses on software validation. Agidens can support this with both criticality assessments and qualification of the different systems.


Agidens provides training on GAMP5, data integrity, csv, ...

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