The validation of computer systems, considered as a medical device or management software, is an industrial necessity and an area of principal interest during inspections and audits.
Computer System Validation
Our services in this sector are focused on support, review and preparation of all documentation during the life-cycle of the project from system implantation, similarly in the execution of the tests that support it.
System validation projects are always carried out by applying a GAMP methodology (Good Automated Manufacturing Practice); internationally recognized as a point of reference to be followed.
Here are some of the types of systems validated following our methodology:
- ERP: Enterprise Resource Planning covering materials and resources.
- EDMS: Electronic documentation management systems.
- EBR: Electronic Batch Record.
- SCADA, DCS, etc.
- Clinical trials.
- Laboratory instrumentation.
- CAPA systems.
- Computer systems qualification.
Methodology for the development and test aimed at development companies or implants.
CSV Experts proposes strategic alliances with developers and software implants. The capacity and specialization of CSV Experts which forms part of you offer to develop or implant will represent a high level of added value and a competitive advantage by virtue of its demonstrated capacity and experience in the demanding environments of regulatory conformance.
IT Quality System
The availability of an IT Quality System department for your Company is fundamental to your regulatory conformance when faced with an audit be it commercial or by the health authorities.
The knowledge of the regulatory requirements and of the work methodology of an IT Department allows us to generate synergies when designing an appropriate Quality System to fit your needs.
- Elaboration of a Quality Policy.
- IT Quality Manual.
- Policies for Validation, Change Control, Incidents, Testing methodology, etc.
- SDLC: Software Development Life Cycle.
Audits of Technology providers
The growing confidence in third party companies who give technological support demands on their quality objectives with regard to the service they provide. The establishment, implied in the Annex 11 of EU GMP, of the need to evaluate your providers obliges organisations to carry out, either on-site or via correspondence, audits of service providers such as:
- Development and maintenance of applications.
- Hosting and housing of IT Services.
- Business Disaster Recovery Plans.