ValidationBeratung zur Nachweisführung, dass ein IT-System die Praxisanforderungen Ihrer Branche erfüllt.
Cost-effective introduction of mandatory validation systems through risk-based approach
YAVEON customers – especially, but not only in the pharmaceutical industry – have a particularly high product quality standard. In addition, these standards are subject to specific legal and industrial requirements to minimize risks that need to be met. This also creates a special obligation for suppliers whose products and services have an impact on the product quality.
Risk Management with a sense of proportion
With YAVEON you have the right partner at your side to fulfill all compliance requirements. YAVEON is one of the few providers of business IT solutions that consistently relies on a GxP-compliant product development and a corresponding To ensure that GxP-compliant implementations of computerized systems are being done correctly right from the beginning, the GAMP Guide (Good Automated Manufacturing Practice) of the International Society of Pharmaceutical Engineeers (ISPE) has established itself as the main guide for these purposes. With the release of GAMP 5, the ISPE has further clarified the guidelines for the creation and launch of a qualified ERP software and made the guide more precise and better suited for practical requirements. The risk-based approach has become the very center of the guide.
Main objectives of the new version of the GAMP guidelines are:
- avoiding duplication of work, especially in closed systems,
- the greater involvement of the validation efforts of suppliers – without losing sight of the qualification process,
- the inclusion of the fact that most systems are configurable and have to be adapted in life cycle,
- and the adaptation of the "V-model" to the various types of computerized systems.
As a result, the risk-based approach of the FDA – as maintained by YAVEON consultants for years – has been confirmed by GAMP 5. The advantage for the user is that the expenditure required for the project are being reduced to a minimum. The test documents created while the system is being developed can be used for future validation for the users and avoid unnecessary duplication of work for the standardized YAVEOn industry solution.
Process-oriented ERP implementation and validation
Business processes are the starting point for the introduction of ERP, BPM and BI systems by YAVEON: This is how the implementation of the processes in the ERP system can be validated. For all business processes requiring validation, YAVEON provides all preconfigurated templates for SOPs (work instructions) and test cases as well as existing documents from the technical and functional specification. All that is left is to adapt them to the specific needs of the company. This procedure saves time and money and increases safety. Finally, the YAVEON employees and partners provide consulting based on their vast validation experience at all stages of the process.