Data is your business compass. Ordina, your data technology partner.
Q is the essential link between quality and pharma/biotechnology. We uphold the interests of the pharmaceutical sector in the field of validation and qualification of equipment, processes and software. We help our customers with their concerns relating to quality and provide a controlled and documented approach in compliance with national and international regulations.
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. Depending on the destination of their products, pharmaceutical companies must comply with the cGxP-directives with the Food & Drug Administration (FDA), the European Medicines Agency (EMA) and/or others.
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.
Q, the Quality & Compliance-team at Ordina, consists of specialists with a scientific background such as industrial engineers, bio-engineers, biotechnologists, biomedical scientists, pharmacists, etc. Our 70-strong team consists of experts from diverse fields such as project engineering, computer system validation, process validation and equipment validation.
Ordina 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 concerning data integrity for systems that store, process or retrieve data (mobile applications, cloud solutions or web applications) even better during their compliance duties.
Give us a call for the following:
CSV: Computer System Validation
Due to the rapid evolution of the technology landscape, computer systems are bound to play an increasingly prominent role. Oftentimes, these systems also have an impact on the quality of your product. Within the pharmaceutical and food industries quality assurance is regulated by statutory bodies such as the FDA, EMEA and ICH. Using IT validation (CSV & infrastructure), Ordina makes it easy for you to comply with and enforce these regulations and controls in a structured way.
Lab Equipment Qualification
Laboratories must comply with a lot of quality requirements and laws. Analytical Instrument Qualification (AIQ) is a must to obtain reliable, accurate and consistent results, whether or not associated with Computer System Validation (CSV) and method validation. We help you meet these strict quality requirements and supports you in applying the various rules and regulations, including FDA, ICH, EMEA, Pharmacopeia, GLP (Good Laboratory Practices) guidelines and ISO standards.
Facility and Process support
The quality of medicines can only be guaranteed if the whole production process is closely monitored and complies with the legal regulations. For this reason, all the processes, procedures and machines in a controlled production environment are subject to strict requirements.
Ordina developed a unique science and risk based solution and ensures that all rules and legally necessary checks (including PAT, ICH Q8, Q9 and Q10) are applied. This allows you to reach the desired quality level quickly and efficiently.