In life sciences, expansion and innovation is inseparable from quality assurance, regulations and legislation. That applies to pharmaceutical and food companies, and therefore to their suppliers. Ordina's Quality Competence Centre helps you in the development of your quality management and your validation approach. We do that based on sound knowledge of guidelines like GxP (GAMP, GEP, …), CMM, CFR 21 CFR part 11, ISO 9001 and ITIL.

 

Do you supply pharmaceutical and food companies? Then it is important for your processes and equipment to meet the requirements of the FDA (U.S. Food & Drug Administration), EMEA (European Medicines Agency) and ICH (International Conference on Harmonisation). Ordina will help you in the setup and screening processes.

 

Is quality management just an expensive obstacle to innovation? No. QM monitors the quality of your products and the reliability of your processes. That leads to satisfied customers, improved safety and better products. In addition, you cut the cost of unnecessary waste of materials and time due to deficiencies in applications, processes or machinery.

 

Ordina's Quality Competence Centre has twenty industrial and bio-engineers. They are at home with regulations, business processes and ICT. Via the Ordina Validation Academy, they receive lengthy, high-quality training in the field from one of the market leaders in the pharmaceutical industry. Based on best practices, and together with your team, our specialists will devise a validation approach tailored to your business's needs. They follow the principles of Science Based Risk Management, as referred to in GAMP5. By selecting the right priorities, you avoid inefficiency due to unnecessary validation and documentation.

 

Ordina offers validation services from audit to implementation. Your current interpretation of GAMP and CFR 21 CFR part 11 is often the starting point for a Master Validation Plan: your plan of approach. This is what Ordina does for you:

mapping out the design and test processes for software, processes and equipment;

integration of various models into one management system (cGxP, CMM, ITIL, ISO9001, CFR 21 CFR part 11);

You optimise your quality management system with specific applications like:

Ordina supports you in the implementation of these packages - from project planning to implementation, validation, training and acceptance testing.

 

Our customer references include Alcon, Agfa, Genzyme, Janssen Pharmaceutica and Pfizer.

Software testing
By testing software defects can be identified. You can then remove them before going into production. This prevents defects to affect the integrity and the correct processing of your data, and as a result the quality of your services and products. By professionally documenting the operation of the system, you also demonstrate that the system operates in accordance with the specifications.

Ordina has developed a structured approach to testing with considerable attention being paid to risk management. Ordina learned the tricks of the trade in the strictly regulated pharmaceutical sector. By adopting a risk-based approach Ordina focuses on the critical points in a development process without jeopardising the quality or the safety of the software. For certain types of test assignments Ordina collaborates with the social profit company Passwerk.