Kwizda Pharma Adopts CARA Life Sciences Platform for Rapid QMS Implementation with Minimal IT Resources

LONDON - EntSun -- Kwizda Pharma, a division of Kwizda Holding GmbH and a leader in the Austrian healthcare market, has selected the CARA Life Sciences Platform from Generis, leading provider of CARA Platform for Content and Data management, to digitise and streamline Quality processes.

With over 170 years of experience in the pharmaceutical industry, Kwizda Pharma develops proprietary over-the-counter (OTC) drugs and operates as a Contract Manufacturing Organisation (CMO).  Kwizda Pharma required a system to upgrade from paper-based and manual processes such as MS Excel trackers for managing quality documentation and training, which led to inefficiencies in compliance tracking, audits, and quality management reviews.

"Maintaining an up-to-date and compliant quality system was becoming increasingly difficult," states Desiree Womser-Matlschweiger, Head of QA at Kwizda Pharma. "Training management, in particular, posed significant challenges, as tracking employee training and physical signatures was a time-consuming process."

Kwizda Pharma selected the CARA Life Sciences Platform for its out-of-the-box (OOTB) configuration, rapid implementation timeline due to minimal additional validation, and cost-effectiveness for smaller companies. The company needed a solution that would allow a seamless transition from paper-based workflows without the burden of lengthy customisations. Additionally, as a CMO, the ability to securely include external collaborators on the platform was an important factor in the selection process.

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"CARA's pre-validated, fully compliant solution was ideal for us, as it reduces the burden internally to handle system validation," Desiree added. "The responsiveness and expertise of the Generis team made for an incredibly smooth selection process; they understood our needs and made the choice simple."

Phase one of the implementation focuses on quality document management and read & understood training workflows, this is set to go live by the end of June. The second phase of the implementation, planned for later this year, will expand the system's capabilities to include a full Quality Management System (QMS) and advanced Learning Management System (LMS) features. Kwizda Pharma also intends to integrate its ERP system to further enhance operational efficiency. By choosing CARA, Kwizda Pharma can consolidate different systems and move away from paper-based processes.

The company looks forward to improved audit readiness and overall quality oversight with the CARA Life Sciences Platform. "Audits are currently quite challenging with our paper-based processes. With CARA, we anticipate a more efficient and transparent audit process, allowing us to focus on continuous improvement." Added Desiree.

By eliminating manual workflows and paper-based processes, Kwizda Pharma expects to see significant efficiency gains across its quality operations. The latest CARA version also includes the 'AI Assistant' which will enable Kwizda Pharma to easily incorporate AI use in the future. The CARA Life Sciences Platform will provide real-time visibility into quality metrics, reduce the administrative burden of compliance management, and ensure seamless collaboration both internally, and with external partners.

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About Generis

Generis is a UK-headquartered developer of world-class data, content and business process management for regulated industries globally. 60% of the top 20 life sciences companies rely on Generis' flagship CARA™ Life Sciences Platform, including AbbVie, UCB, Biogen, Reckitt, Bristol Myers Squibb, Bayer, Pfizer, and Merck KGaA. Today Generis serves more than 750,000 users worldwide, across use cases ranging from RIM, Regulatory / R&D and Safety to Clinical, Non-clinical, Quality GxP, CMC, Pharmacovigilance, Medical Information / Medical Affairs applications and more. More at www.caralifesciences.generiscorp.com .
About Kwizda Pharma

Kwizda Pharma is a division of Kwizda Holding GmbH, a family-run Austrian company with a long-standing reputation in the healthcare sector. With more than 170 years of experience, Kwizda Pharma develops proprietary over-the-counter (OTC) drugs and provides pharmaceutical services ranging from development to supply. The company operates internationally and also functions as a Contract Manufacturing Organisation (CMO), supporting high-quality pharmaceutical production and distribution.