Compliance and Validation
As the Claromentis reseller in Australia, R&D Knowledge Services have the privilege of talking to many interesting and varied companies. A recent discussion with a pharmaceutical company brought up the issue of not only how companies go about creating new documents, but also about how the software is compliant with FDA an TGA regulations.
We all know Claromentis offers exception capabilities in regards to document management (audit, version, granular permissions, roll back, searching etc etc) but in these highly regulated industries, the complainace and validation of such systems is of equal importance.
The US Food and Drug Administration (FDA) and the Australian TGA (Therapeutic Goods Administration) require manufacturers to comply with stringent conditions to ensure integrity of the drug approval process. 21CFR is of particular importance, and we are currently working to ensure Claromentis passes these tests. More to come as we tread down this validation path.
