CSVapt??is the brand new service product of IT-Testing.de? and stands for an optimized Computerized System Validation | adapted | precise | tailormade.
- The regulated company takes center stage to ensure patient safety, product quality and data integrity.
- The management will commit to the requirements of the regulated field.
- The employees will learn, understand and implement the world of work and the working methods of the regulated field.
- The service providers will see themselves as an extension of the regulated company and will act accordingly.
- The computerized systems and processes are validated exactly as will be required based on risk.
- The work instructions and process descriptions are formulated precisely and are aimed according the actual regulatory purpose.
- The forms contain exactly the information required for the regulatory work field.
- The process interfaces to the external and internal service providers are precisely defined.
- The specifications for the interfaces are implemented in a targeted manner and the functionality of the interfaces is established.
CSVapt??tailormade means:
- The scope of the documentation is kept according to the regulatory requirements.
- The service providers are accurately selected and qualified according to the regulatory purpose.
- The employees are properly prepared for the specific audits.
- The internal CSV team is trained according to the requirements in a purposeful and appropriate way.
- The management receives appropriate rules for the control and traceability of the implemented measures.
IT-Testing.de? supports your regulated company to implement and anchor the?CSVapt??in the daily work routine of each single employee. It is the essential ingredient of your business and production processes. CSVapt??will be built in with the implementation of new processes ideally but can also be integrated in existing processes as well.
But: Validation can’t wait!
Thus, do not hesitate to contact IT-Testing.de? straight away!
