quality-and-compliance

Quality & Compliance

Aim for quality with Ordina

Ordina assists companies in the pharmaceutical and biotechnological sector with the optimisation of production processes, automation of systems, software implementation and computer system validation.

We know the rules

Safety and efficiency are crucial in your sector. Research, development, production and distribution are therefore subject to strict rules, both global and local. Examples are the cGxP guidelines of the Food & Drug Administration (FDA) and the European Medicines Agency (EMA). In every step of our cooperation we proceed in a very controlled way, in accordance with all national and international regulations. The whole process is carefully documented. So you can be sure of qualitative processes that pass every audit with flying colours.

70 quality and compliance experts

Q, Ordina’s Quality and Compliance team, is the quality partner of pharmaceutical and biotechnology companies. 70 experts from different backgrounds, such as industrial engineers, bioengineers, biomedicals and pharmaceutical experts, are at your service. They help you to validate and qualify your material, processes and software. Can you use help to optimize your production processes, automate systems, implement software or validate laboratory systems in this highly regulated market? Our team knows how to hit the whip.

We help you with this

  • Computer system validation (CSV)

The technology landscape is changing rapidly and the role of computer systems is becoming increasingly prominent. Certainly in sectors such as pharmaceuticals and foodstuffs, where quality is guaranteed by legal authorities such as the FDA, the EMEA and the ICH, they also have an impact on the quality of the end product. Our CSV services ensure that you comply with all regulations and checks.

  • Qualification of laboratory equipment

Laboratories have to comply with many laws and quality requirements. Analytical instrument qualification (AIQ) is a must in order to obtain reliable, accurate and consistent results, whether or not combined with computer system validation (CSV) and method validation. We help you to comply with these strict quality requirements and support you in applying the various rules and regulations, including FDA, ICH, EMEA, Pharmacopeia, good laboratory practices guidelines (GLP) and ISO standards.

  • Support for your facilities and processes

In order to guarantee the quality of medicines, it is important that the entire production process is closely monitored and complies with the legal requirements. Ordina has developed a unique method, based on scientific research and risk analysis, to ensure that all rules and legally required controls are applied. In this way we guarantee that you will quickly and efficiently reach the highest quality level.