Computer system validation and software validation (CSV) ensure that procedures, processes or operations of computer-based systems lead to a reproducible desired result. Wherever you support or replace a manual process with a computer-based system, you must prove the suitability of that system.
CSV is a current and complex topic for companies in GxP-regulated areas (such as the pharmaceutical industry and medical engineering). The validation of these systems is prescribed by various standards and regulations, e.g. in DIN EN ISO 13485:2016, DIN EN 62304 or Annex 11 of the EU GMP guidelines, but implementation in practice initially appears difficult.
For pharmaceutical and medical technology companies, it is advisable to define a pragmatic approach for the validation process and to always proceed in a practice-oriented and risk-based manner during the validation process. In general, software that is used within the framework of a quality management system must be validated. Such software is used in areas such as document, change or deviation management. Further applications can also be found in test equipment management or in the control of monitoring systems in warehouses and during transport.
Overview of regulations, standards and guidelines:
Our experts support you in the validation of your computer and software systems.
Contact us – together we will create a software matrix and determine the validation relevance of the software used in your company. Finally, the validation of your systems is carried out according to a risk-based validation approach in accordance with the specifications of GAMP 5.