Validation and Qualification
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.
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.
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.
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.
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: