The use of ConSense software supports GxP-relevant processes
From a family pharmacy to a pharmaceutical and chemical corporation: Kwizda, a Viennese company founded in 1853, now consists of several divisions including Pharmaceutical Production, Distribution and Trade, Agro (plant protection), Cosmetics and Sealing. With Apotronik, Kwizda established its own management and information system for Austrian pharmacies. The Kwizda Group with around 1,200 employees has branches in 10 countries, holds around 240 active drug registrations and supplies over 1,300 pharmacies throughout Austria with medicines. The group headquarters is located in Vienna, other larger international sites are located in France, Hungary, Romania and the Czech Republic. Kwizda is still managed as a family business.
A need for a uniform quality management system
Across the different business areas of the Kwizda Group, there is a need to adhere strictly to the codes of quality standards and to have a clear separation of responsibilities in order to meet them. Process optimisation is a continuous and daily undertaking within all divisions of the group. "In 2015, this led to the decision to bring the various business areas and sites under one roof with a uniform quality management system,” recalls Roland Zieger, the IT project manager responsible for this project.
Life sciences require a GxP-compliant system
As a group of companies operating in the life science sector, the processes and documentation of three divisions - the holding company, pharmaceutical wholesale and pharmaceutical distribution - have to comply with complex specifications within the framework of European regulations and guidelines for the manufacture of medical products, such as EudraLex GMP Directive Vol. 4 Annex 11. The basic license ConSense GxP ENTERPRISE, which Kwizda chose, is tailored to these needs. The software supports GxP-compliant processes in the company, facilitates the introduction and implementation of new processes that are associated with a large number of regulations, firmly defined procedures, documentation and a high level of training, maps workflows for regulated validation procedures and offers particularly high protection against unauthorised access. The functions of ConSense GxP can be adapted to company-specific processes and specifications. "A major plus point was the validation of ConSense GxP software in our company, as many other manufacturers do not offer this", emphasises Roland Zieger. After a test phase, the validation was carried out before the go-ahead was given: the system could then be put into productive service in January 2015.
Effort rewarded by prompt certification
The new QM system was eagerly awaited by the Agro Division which was imminently expecting certification. ConSense was to be implemented immediately to undergo the final certification.
The entire success story is available in German.