Toxikon Europe is a clinical research organisation that is aimed at biotech and pharmaceutical companies and the medical devices industry. Toxikon provides specialist services for the development of new products, from concept stage to final product delivery. The company focuses on analytical services, microbiological and in vitro assays. The European branch also specialises in researching extractables and leachables. As a Contract Research Organisation, Toxikon is accredited by the Belgian Ministry of Public Health for the analysis and control of pharmaceutical products. Their working environment and laboratories are subject to specific laws and regulations. Ordina has already worked for many leading suppliers, producers, contract manufacturers, service laboratories and consultancies, and has many years’ experience of the relevant laws and regulations (cGxP, CFR21 Part 11, ISO 9001 or ISO 13485).
Toxikon called on the services of the Ordina Quality & Compliance team to meet the requirements imposed within the complex regulations of their business activities. Ordina’s Quality consultants were used to evaluate the lab equipment that must comply with cGMP, and specifically the computer systems used, for compliance with 21 CFR Part 11. Thirteen systems were examined piece by piece during an on-site assessment and remediation activities were performed on priority systems.