In Line with regulatory Requirements
Quality & compliance
Werum’s PAS-X software product including the development process meets all requirements set forth by the approving authorities for operating computer systems in regulated industries. PAS-X functionality complies with regulatory requirements, such as the ones set forth in the EU GMP guidelines including the GMP Annex 11 for Computerized Systems Guidelines and the FDA guidelines 21 CFR Part 11 and 21 CFR Part 210/211.
Risk-based approach in PAS-X software projects
Our software development life cycle follows the risk-based approach described in the ISPE GAMP 5 guideline (Category 4 - Configurable Products).
Validation expertise network
Werum has excellent relations with validation consultants. Also, Werum is a member of the ISPE, the GAMP Supplier Forum, the GAMP D-A-CH Forum, and other organizations. In this vein, we are actively involved in current hot issues and are always up-to-date on the newest developments.
Werum is audited by its customers. This way, our customers can see for themselves that the quality of our processes satisfies all their standards. Some of our customers joined forces to carry out common audits on a regular basis. As a result, redundancies during the preparation, execution, and post-processing of the audits can be avoided for all parties involved and the auditing efforts can be reduced.
Werum is DIN EN ISO 9001-certified. Our customers can be sure that we keep our certification up-to-date so that they know that our work is always based on a solid, well-established quality management system.
Project Quality Management System (ProQuMaS)
Werum’s quality management focuses specifically on the Software Development Lifecycle (SDLC) of our PAS-X projects. Our software development process follows a clearly structured, high-quality procedure providing detailed evidence of all development activities. This complex process is supported by ProQuMaS, our Project Quality Management System. It ensures that any changes in the SDLC documents and the related test cases are recorded to enable traceability. Thus, our customers can trust in the high quality of our software.
Do you have specific questions about quality and compliance issues?
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