Kwizda Pharma GmbH

Kwizda Pharma GmbH of Austria markets more than 50 product lines. With activities in 21 countries, the firm has a total of more than 500 active drug approvals. Obtaining approval for new drugs is extremely costly and time-consuming. Generating, administering, and handling a growing number of approvals has become a Herculean task for companies that produce and sell pharmaceuticals.

Kwizda desired a new solution that would be capable of electronically mapping all of its approval processes. They wanted to have all recently submitted documents available at a moment’s notice plus have the ability to track changes with very little effort. Generally speaking, the new solution had to provide seam­less documentation and traceability of all changes in the archive. At the same time, Kwizda wanted to be prepared for the launching of the EU standard known as eCTD (electronic Common Technical Document).

Following a thorough evaluation of solutions cur­rently available on the market, Kwizda decided to go with a custom solution based on ECM techno­logy from SAPERION. Vienna-based Artaker Com­putersysteme GmbH was chosen to implement the system and shared responsibility for success of the project with Kwizda’s IT department.