The production of medical drugs is subject to specific regulations set forth by national and
international authorities. Manufacturing Execution Systems have to provide the functions
needed to comply with these regulations. The validation of computer systems requires that
not only the software but also the entire development process has to meet these high-level
requirement standards.
We use established procedures, which go far beyond the ISO 9001 guidelines.
PAS-X functionality complies with the regulatory requirements, such as the ones set forth in
the EU GMP guidelines or
the FDA guidelines 21 CFR Part 11 and
21 CFR Part 210/211.
The development life cycle we apply follows the ISPE GAMP5 guideline.
PAS-X software development based on risk-based approach as per GAMP 5 (Category 4 - Configurable Products)
We have excellent relations with validation consultants and are continuously in contact with the FDA.
Also, we are 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. In addition, we regularly make our technical know-how in the validation
field available at events organized by Concept Heidelberg.
For more than 15 years, we have been audited by our customers. This way, our customers can see for themselves that the quality of our processes satisfies all their standards. Some of our customers have come together to carry out joint audits on a regular basis. As a result, redundancies during the preparation, execution, and post-processing of the audits can be avoided for all the parties involved and the auditing efforts can be reduced.
For us, quality management system is not just a word - we live it. The
high-quality of our products and services is a testimony to this.
Werum Software & Systems is IN 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.
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Regulatory Requirements 
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