Computer & Software Validation

A pharmaceutical company that operates internationally is obliged to comply with governmental guidelines on the research and manufacture of drugs. Such guidelines were also published for the development and operation of computer-assisted systems (e.g. Annex 11 to the EU-GMP Guideline, OECD Consensus Document). Pharmaceutical companies are thus obliged to establish and evaluate quality management measures for the compilation of the software used in order to be able to prove the integrity of electronic data and documents for the safety, reliability and quality of their regulated products.

EXTEDO’s clients are correspondingly dependent on a mature and compliant technical and business process integration of its customized and standard software solutions.

The basis for EXTEDO’s CSV process of software systems is the following:

Each individual activity for the development and integration of EXTEDO’s solutions is clearly defined, planned, tracked and documented. Once defined, this set of rules represents the basis for the compliant system validation. EXTEDO helps to establish a continuous process of improvement in the software development, integration and update process.

Computer and software validation builds on consistent documentation, beginning with the principles for validation, SOPs for project-specific validation plans, installation plan und protocol, test plans and protocols, performance qualification and change documents. For the compilation of documents and check lists EXTEDO orients itself on internationally recognized standards and on many years of practical expertise.

EXTEDO’s standard products are accompanied by standard CSV packages based on documents as well as associated software validation support services. EXTEDO accelerates the efficient preparation, performance and documentation of the tests and provides valuable support for accurate reviews and inspections.