Saarbrücken, April 28, 2017: CROMA-PHARMA GmbH in Leobendorf near Vienna is an internationally active family business in the field of aesthetic dermatology. CROMA-PHARMA now relies on the regulatory compliance expertise of DHC Business Solutions for the introduction of integrated quality management system software.
Across all industries, quality problems and the resulting economic damage have increased noticeably in recent years. The reasons are essentially greater product complexity, shorter time-to-market and global manufacturing with increasingly global value chains. In the context of “Quality 4.0” initiatives, existing quality management approaches are therefore being reconsidered and new IT systems implemented. The focus is on the management of quality notifications and anomalies, i.e. deviations or complaints, and the appropriate measures. Stringent CAPA management software (Corrective and Preventive Actions) is designed to reduce the number of quality incidents, decrease the frequency of product recalls, and significantly reduce associated costs. The overarching concern is the continuous improvement of quality in production.
Transparency is the guarantor for compliant CAPA management
CAPA management is an established procedure at CROMA-PHARMA for the continuous improvement of quality. The focus is on “nonconformities”, i.e. conspicuous features of all kinds: Deviations, Complaints, Material Defects, Out of Specification (OOS) and Out of Limit incidents, and Audit Findings. They all trigger detailed analysis and diagnostics. Measures to eliminate the causes of anomalies are initiated and their effect subsequently analyzed. For effective and reliable CAPA management, “Corrective Actions” are combined directly with “Preventive Actions”. In the future, all this will take place at CROMA-PHARMA within the framework of an integrated management solution based on DHC VISION.
For Martin Lenzenweger, MSc, Head of Quality Assurance at CROMA-PHARMA, the introduction of this solution is the core of a comprehensive digital evolution and transformation within the company. This means that Lenzenweger is fully in line with the trend: The Gartner CIO Agenda 2017 recently predicted a new level of maturity in digitization that can only be achieved by modernizing core technologies.
And this digital transformation is urgently needed: “The partly paper-based processes and local individual applications in CAPA management cannot withstand CROMA-PHARMA’s international commercial growth in the long term.”, says Lenzenweger. Lenzenweger expects better results from the new solution, especially when it comes to analyzing the causes of anomalies: “Where data silos used to make our work difficult, we now have an integrated system and thus significantly more transparency”. Simpler and at the same time harmonized Q-processes are the goal. This is because CROMA-PHARMA is not only expanding in terms of production, but is also about to enter the FDA-regulated growth market of the USA. This leads to significantly more regulatory complexity, which in turn can only be managed with more professionalization, with greater efficiency and significantly shorter lead times in CAPA management.
The decision in favor of DHC VISION was preceded by a lengthy selection process at CROMA-PHARMA. Marleen Pruscha, BSc, Quality Assurance Manager at CROMA-PHARMA, comments on this: “We were particularly impressed by the ease of use and high level of user-friendliness, the appealing design, the well thought-out, logical system structure of DHC VISION and the high degree of coverage of the system with our special requirements at CROMA-PHARMA. In addition, the customer proximity and the support processes of DHC Business Solutions, which are suitable for medium-sized businesses, played an important role”.
Smart Validation for FDA and GxP compliance
Software systems relevant to GxP must be validated. To keep the validation effort manageable, CROMA-PHARMA uses the “DHC VISION Validation Accelerators“. These are templates and process models for all essential steps of the validation – from the validation plan to the Part 11 analysis, the user requirements specification (URS) and the test case definition to the final validation report. Such templates are at the heart of DHC’s process- and risk-based validation methodology. It has become widely accepted in the chemical and pharmaceutical industries as it supports a significantly accelerated validation process with considerably reduced effort. Marleen Pruscha adds: “Decisive for our decision were also the validation expertise of DHC and not least the recommendations of other companies in the chemical and pharmaceutical sector”.
Dr. Wolfgang Kraemer, Managing Director of DHC Business Solutions, is looking forward to accompanying the further digitization of Q-processes at CROMA-PHARMA in the coming years: „“The introduction of DHC VISION gradually includes CAPA– and change control management as well as the regulatory-relevant life science core processes for SOP and Training Management with integrated learning success monitoring to prove training success. By running DHC VISION in the Microsoft Azure Cloud and DHC Business Solutions’ Managed Application Services, we can align the scaling benefits both functionally and technically as our customers grow.”
CROMA-PHARMA is an internationally active family-owned company based in Austria, which has been developing and producing innovative medicinal products and medical devices for the fields of ophthalmology, orthopedics and aesthetic dermatology for 41 years. In this way, CROMA-PHARMA makes important contributions to improving health and quality of life. CROMA-PHARMA was founded in 1976 as a family business by the pharmacist couple Karin and Gerhard Prinz in Vienna. The company is now a global player in the minimally invasive aesthetic medicine segment. The products are distributed through a network of 12 of its own sales organizations as well as through strategic partnerships and distributors in more than 70 countries. For more information about ITM, please visit: at.croma.at/home-de/.