Simplify software validation and revalidation (CSV) with the right software tools
Companies in the medical technology industry are currently working at full speed to implement the new Medical Device Regulation (MDR). The validation of production/company processes is an effort that should not be underestimated. The validation obligation also extends to the software systems used, which are involved in development and production-relevant processes. Examples include document management systems (DMS/ECM), software for quality assurance (CAQ systems), PLM and ERP systems.
In October 2019, majesty GmbH was accepted into the "Lace on the Land" funding line with the idea of developing software for simplified software validation. The module has been completed since the end of 2020 and is now available to users of the ERP industry software Majesty.The Problem:
The initial validation of an ERP system requires a large technical and financial effort. First, it must be investigated which ERP functionalities are to be classified as "critical". Then tests must be developed, executed and documented for these functions. Examples of this are batch tracing or incoming goods inspection. Once the hurdle of initial validation has been cleared, companies regularly shy away from installing updates to their ERP software. The reason: a time-consuming and costly revalidation might become necessary. Assessing this often requires several man-days of consulting, depending on the scope of the update. However, updates are necessary to comply with important legislative changes, fix bugs and close security gaps.The solution:
For the initial validation of the ERP industry solution Majesty, majesty GmbH offers a complete sample validation. For the ideal case that users work with the standard configuration, the majority of the validation effort is covered with these documents. Otherwise, the tests can be customized and performed by the user.
The new Majesty module is used for revalidation. It contains an electronic function catalog, the possibility to classify functions according to criticality, the storage of function tests with reference to function catalog numbers and the documentation of performed function tests. Furthermore, the change logs can be used to automatically check whether a revalidation or the performance of functional tests is required before an update is put into operation. This makes it possible to estimate the validation effort before an update is implemented.The following advantages are offered by the "Validation" module:
- Estimation of the validation effort before performing an update.
- Online provision and maintenance of the entire Majesty function catalog through majesty GmbH.
- Functions can be individually evaluated and classified into four different risk categories (not evaluated, critical, non-critical and unused).
- Time and cost savings when performing a revalidation, as all critical processes affected by the update are clearly displayed.
- All information about performed tests is stored in Majesty and can be retrieved at a later point in time with just a few clicks.
- Users benefit from the continuous further development of the ERP system Majesty, which - after checking the critical changes - is made possible with the installation of new updates.