All pharmaceutical or biotechnology companies struggle with the balance between compliance and innovation. The Ordina life sciences sector team offers help in both areas. But they are not alone in taking up this task. When a company calls for a compliance solution, the team calls in the help of Tom Voet and his colleagues from the Ordina Quality & Compliance (Q&C) team. Tom has worked on computer validation for the pharmaceutical sector for more than 20 years.
The catalogue of rules and legislation with which life science companies have to comply is growing in scope and complexity. There are technical product requirements, rules on market access and data usage along with good laboratory, clinical, manufacturing and distribution practices. The computer systems that life science companies use also have to be validated, although that isn’t anything new. The rules governing computer system validation (CSV) date back to 1997.