Medicines must be pure, safe and effective. Therefore, research, development, production and distribution in the pharmaceutical and biotech industry are always linked to compliance with global and local regulations. The Quality-team at Ordina supports leading pharmaceutical companies and their suppliers in the design and implementation of their quality assurance with consulting and audit services. The expertise of our consultants is very broad: from optimizing production processes, automation of systems, software implementation to validation of lab systems and methods and everything in between.
- How do you ensure that the correct procedures are followed in the various facilities for sterile and accurate work?
- How do you validate the systems used (software, devices and processes) and define critical steps and risks?
- Are you dealing with complaints about quality adequately and do you use them to improve processes?
The ‘Quality & Compliance’-team of Ordina consists of specialists with a scientific background, such as industrial engineers, bio-engineers, biotechnologists, biomedical scientists, pharmacists, etc. Our 75-strong team consists of experts from diverse fields such as project engineering, computer system validation, process validation and equipment validation.
Ordina’s quality and compliance consultants work for leading pharmaceutical companies and their suppliers where quality and strict compliance with regulations and legislations are a must. They have a thorough knowledge of the regulations and legislation (cGxP, CFR21 Part 11, ISO, etc.) and have the opportunity to go through the Ordina ‘secure by design program’ (CISSP(ISC)2, CISA, CISM). This allows our experts to estimate the risks even better concerning data integrity for systems that store, process or retrieve data (mobile applications, cloud solutions or web applications) during their compliance duties.
Ordina Q-consultants are thus multidisciplinary and are intensively coached and trained in this. We are no boring club … In addition to training and knowledge sharing, there are several team building activities and a Q-weekend scheduled. Professional and private experiences are announced thanks to ’t Orvalleke, our own quality news magazine.