We ensure that our Werum PAS-X MES software runs securely, reliably, and smoothly at your company. The software fulfills all the requirements that the regulatory authorities impose on the operation of computer systems in the regulated industry. With its functions, PAS-X meets, for example the GMP requirements according to the EU-GMP guidelines, including “GMP Annex 11 for Computerized Systems” as well as the FDA guidelines “21 CFR Part 11” and ”21 CFR Part 210/211”.
We use a variety of measures to ensure that the regulatory requirements concerning quality and compliance are met:
- Risk-based approach:
A risk-based approach that minimizes overheads while maximizing security. We develop software according to a life cycle in compliance with the ISPE GAMP5 Guideline (Category 4 — "Configurable Products"). - Part of the validation competence network:
We are a member of the ISPE, the GAMP Supplier Forum, the GAMP D-A-CH Forum, and other organizations. - Customer audits:
We are evaluated and certified by our customers at regular intervals. Some of our customers have joined forces and regularly conduct so-called "joint audits". This avoids redundancies on all sides in the preparation, execution and follow-up of the audits and reduces the audit effort. - ISO certification:
We are certified according to DIN EN ISO 9001, thus giving our customers the assurance that we are continuously operating on the basis of a solid and well-established quality management system. - Project Quality Management System (ProQuMaS/PQM Doors):
Our quality management system is primarily designed towards the software development life cycle (SDLC) of our Werum PAS-X MES projects. It ensures that detailed evidence of all development activities is available at any time. We use ProQuMaS/PQM Doors to support this complex process.
Benefit from our expertise so that you can concentrate on your core business.