Freya Wolles Business Development Manager Q +32 496 77 45 14

Quality & Compliance

ONGOING COMMITMENT to quality

Knowledge is vitally important in the pharmaceutical sector. From raw data from experiments to complex chemical formulae; from precisely executed drug trials to intellectual property rights – without this information the sector would be unable to perform. In case of loss or damage of this confidential information, an organisation puts itself and its customers at irrevocably at risk. Awareness and responsible management of information risks are vital for the healthy functioning of the pharmaceutical sector.
The pharmaceutical industry is therefore one of the most regulated sectors. The legislation and regulations of the FDA/EU 21 CFR Part 11 clearly set out the requirements in terms of reliability and authenticity of data created and stored electronically.

Ordina’s Quality and Validation consultants work from leading pharmaceutical companies and their suppliers. They have an in-depth knowledge of the regulations and legislation (cGxP, CFR21 Part 11, ISO 9001 or ISO 13485) and completed the Ordina Secure-by-Design programme (CISSP(ISC)2, CISA, CISM)

Quality & Compliance Contact Contact Freya Wolles

Computer System Validation (CSV)

TECHNOLOGY ADAPTED TO STATUTORY QUALITY CONTROLS


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 (end) 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.

Computer System Validation

Facility and Process Support

QUALITY ORIENTED PRODUCTION PROCESS

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 for you a unique science & 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.

Facility and Process Support

Lab Equipment Qualification

GUARANTEE THE QUALITY OF YOUR WORKING METHOD AND RESULT

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. Ordina helps 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.

Lab Equipment Qualification

Managed Q Services

CROSS-FERTILIZATION BETWEEN QUALITY & TECHNOLOGY

The scope of technological possibilities for your company is constantly expanding. On the one hand, it is important to keep up with the available technology and use it optimally, and on the other, this technology must also comply with the high quality standards and laws and regulations. With Ordina’s Managed Quality Services model (MQS) you achieve the perfect cross-fertilization between quality and technology. The MQS model guarantees knowledge inflow, flexible support, fast response and the elimination of ‘idle time’.

Managed Q Services

Secure by Design

SECURITY IS IN THE DNA OF EVERY ORDINA CONSULTANT! 

Security is a prerequisite for safeguarding your company’s interests and goals. It ensures the protection of business information and processes, regardless of the form. According to Ordina, “security” is as strong as its weakest link.For that reason we don’t see this as a separate service. Security requires an approach that takes account of the standards and regulations within your market segment, with the security of your data, your software applications and your infrastructure landscape. Embedding and safeguarding your security is a crucial part of our service. Security is in the DNA of every Ordina consultant! The “Secure-by-Design”-approach at Ordina makes that you have secure solutions that ensure the security and privacy of your organisation and offer added value.

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