quality-and-compliance

Quality & Compliance

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The Q team

Ordina’s Quality & Compliance team (Q) consists of 70 consultants: experts in areas such as project engineering, computer system validation, process validation and equipment validation. Q’ers always have a scientific background: industrial engineers, bio-engineers, biotechnologists, biomedical scientists, pharmacists, etc.

We have extensive knowledge of regulations and legislation such as cGxP, CFR21 Part 11, ISO, etc. In addition, there is the possibility of going through the Ordina Secure by Design programme, with a focus on CISSP(ISC)2, CISA and CISM. During compliance assignments, our experts can assess the risks in terms of data integrity for systems that store, process or read data. Ordina Q consultants are therefore multidisciplinary and are intensively coached and trained. In addition to training and knowledge sharing, several teambuilding activities and a Q-weekend are planned each year. Professional and private experiences are announced via our own news magazine.

Quality & compliance, why?

Medicines must be clean, safe and effective. That is why research, development, production and distribution in the pharmaceutical and biotech industries are always linked to compliance with global and local regulations. Ordina’s Q team supports leading pharmaceutical companies and their suppliers in the design and implementation of their quality assurance with consultancy and audit services. The expertise of our team is very broad: optimizing production processes, automation of systems, implementation of software, validation of lab systems and methods … and everything in between.