Compliance & Validation in the CloudKUMAVISION reduces the workload for medical technology companies
Jens Fröhlich
Principal Consultant Operations – Portfolio Management MEDTEC
Medical technology companies face complex regulatory challenges when validating enterprise software, such as ERP systems. Validation must be performed not only before the first use, but also with every change or update to the software – even with Cloud-based systems with regular updates. This creates unease among many IT managers and quality management officers within companies. Traditional validation approaches based on CSV (Computer System Validation) are often document-intensive, resource-intensive, and difficult to scale. This leads to high costs and delays in the introduction of new technologies.
GAMP5 2nd Edition: The Path to Risk-Based Validation
The second edition of the GAMP5 guidelines represents a paradigm shift: away from the comprehensive validation of every function and toward a risk-based approach with a focus on critical thinking. Validation is now based on the actual GxP relevance of a process and the implementation method (configuration vs. customer-specific adaptation). This allows for a targeted testing strategy that significantly reduces effort and documentation and can be aligned with the actual risk. New technologies are now also available that can essentially automate test execution.
“We have tested and expanded these new technological possibilities and thus created a tool that is unique for the execution and documentation of validation tests,” says Jens Fröhlich, who works as a Principal Consultant in the MEDTEC portfolio management of KUMAVISION AG.
Integrated and automated validation with KUMAVISION medtec365
The on Microsoft Dynamics 365 Business Central-based ERP industry solution KUMAVISION medtec365 for medical technology supports medical device manufacturers in implementing this new validation strategy. Of particular note are:
- Microsoft Page Scripting and User Acceptance Testing
With Page Scripting, key users can record their own processes, which then run automatically and can be repeated at any time. The "User Acceptance Test" app documents the test results in an audit-proof manner and enables easy reuse and automated execution of the tests, for example, for updates. This significantly reduces the effort required for manual testing and increases repeatability and traceability through recording and documentation.
- Automated tests at Cloud-Updates by Microsoft and medtec365-Extensions.
KUMAVISION regularly conducts automated tests – both for the current and future versions. This ensures that new versions of medtec365 already tested to the best of its ability and reach the customer.
- Validation package with reference processes and document templates
The included validation package contains a reference process list with requirements and specifications, all validation documents, and specifications for all relevant processes. This enables quick comparison with current company processes and reduces documentation effort by up to 70%.
In addition, the ERP software medtec365 Well-equipped to comply with regulatory requirements: The industry solution offers numerous features specifically tailored to the needs of the medical technology industry. These include:
- Audit trail and multi-level electronic signature according to FDA 21 CFR Part 11
- Complaints and action management according to DIN EN ISO 13485, FDA and MDR
- Audit module for internal and external audits of suppliers
- Mandatory field check and blocking logic for master data
- Quality control with test equipment management and calibration management
- Integration with ELO ECM Suite or Microsoft SharePoint for controlled documents
Conclusion: Efficient validation with medtec365
With medtec365 Medical technology companies receive a solution that not only meets regulatory requirements but also drastically reduces validation effort. The combination of risk-based methodology, automated tests, and preconfigured documents makes medtec365 the ideal platform for companies that want to make their processes efficient and compliant.
