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

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.

Concept

Our experienced Quality & Compliance consultants share their extensive expertise to support you during the IT validation process. They guide you in the planning and risk analysis, specification (requirement definition), verification (IQ, functional and requirements testing) and reporting.

Approach

Ordina can pride itself on a thorough knowledge of relevant regulations and laws, including the V-model, cGxP, 21 CFR Part 11, GAMP5 and FDA, EMEA and ISO standards (ISO). We align the IT validation with your own business rules or the Ordina template.

Result

All the software and infrastructure deployed by Ordina undergoes an extensive validation process and complies with current legislation. With these qualitative, safe and reliable solutions you can be assured of a worry-free audit.

Computer System Validation (CSV) Contact Contact Freya Wolles