Securing sustained GxP compliance with DHC VISION

CROMA-PHARMA GmbH is an Austrian family business with global operations and specializing in aesthetic dermatology. CROMA-PHARMA valued DHC’s expertise in regulatory compliance when implementing an integrated quality management software solution.

The number of quality issues and the scope of ensuing economic damages have increased over the last year across industry sectors. This is due mainly to growing product complexity, reduced time to market, as well as world-wide manufacturing operations with global supply and value chains. In the wake of the Industrial Internet of Things, many manufacturers currently are rethinking their traditional approaches to quality management, thus turning toward a new generation of software solutions. The focus, thereby, is on managing quality notifications and anomalies, i.e. deviations or complaints, and on initiating appropriate counter-measures. Stringent CAPA (Corrective and Preventive Actions) management is geared toward reducing the number of quality issues significantly and to lower associated costs. The overall concern is to improve quality in production on a continuous basis.

Transparency is key to GxP-compliant CAPA management

At CROMA-PHARMA, CAPA management is a well-established approach to continuous quality improvement. The focus, thereby, is on “non-conformities”, i.e. anomalies of all kinds. This includes “out of specification” (OOS) and “out of limit” issues as well as “audit findings”. They trigger detailed analyses and diagnoses, which then lead to corrective actions and comprehensive evaluations of their results. Effective CAPA management, thus, combines “corrective actions” with “preventive actions”; COMA-PHARMA now has decided to digitize their CAPA management processes using DHC VISION.

Martin Lenzenweger, MSc. and Head of Quality Assurance at CROMA-PHARMA, considers the implementation of DHC VISION a first step toward a comprehensive digital evolution and transformation. This is perfectly in line with what the latest Gartner CIO Agenda 2017 points out: Manufacturers move to the next level of digital maturity only when updating and modernizing core technologies.

A “digital transformation” of core quality processes is needed more than ever: “The international expansion of our operations will not be successful with paper-based CAPA processes and stand-alone software applications,” Lenzenweger points out. “With DHC VISION, we now have an integrated software system, which offers more transparency than the isolated data silos we had in place before.” The goal is to achieve significantly better analysis results and to implement straight-forward as well as streamlined quality processes. As CROMA-PHARMA not only is expanding its production facilities but also currently is preparing to enter the FDA-regulated U.S. growth market, novel approaches to quality management are needed. This is how the company intends to successfully tackle the new levels of regulatory complexity it will be facing. Hence, emphasis is put on professionalization in quality management, efficient processes, and on significantly shorter throughput times in CAPA management.

The decision in favor of DHC VISION was the result of a complex selection process. Marleen Pruscha, BSc. and Quality Assurance Manager at CROMA-PHARMA, points out: “We were particularly convinced of the easy system handling, of its usability and attractive interface design. We were also impressed by the well thought out and logical system concept and the system’s comprehensive coverage of our specific functional demands. Last but not least, DHC Business Solutions provides customer-oriented and SME-compatible support processes; this is something we appreciate a lot.”

Smart System Validation to secure FDA and GxP compliance

GxP-critical software systems need validation. For efficient system validation, CROMA-PHARMA uses “DHC VISION Validation Accelerators”, i.e. a set of document templates covering all steps of the validation process, from Part 11 Analysis to user requirements specification (URS) and test case definition to the final validation report. The templates are at the center of DHC’s process- and risk-based validation approach, which figures prominently in the chemical and pharmaceutical industries. The results are reduced validation costs and speedy system validation. Marleen Pruscha adds: “DHC’s experience and expertise in system validation was of particular interest to us, as were the quite positive recommendations we received from other chemical and pharmaceutical companies.”

Dr. Wolfgang Kraemer, Managing Director at DHC Business Solutions, is proud of the chance to support the further digitization of quality processes at CROMA-PHARMA over the next years. “The focus currently is on implementing digital CAPA and Change Management processes. Next, we will digitize further core regulatory processes specific to the Life Sciences, i.e. SOP and training management with integrated learning success identification and documented training results. As we operate DHC VISION in the Microsoft Azure Cloud and provide managed application services, we will achieve economies of scale in technical as well as functional terms to the benefit of CROMA-PHARMA and our partner’s strategy of growth.”

CROMA-PHARMA GmbH

CROMA-PHARMA is an Austria-based family business with international operations. For over 41 years, the company has developed and produced pharmaceuticals and medical products in the areas of ophthalmology, orthopedics and aesthetic dermatology. With its products, CROMA-PHARMA contributes to improving health and the quality of life. CROMA-PHARMA was established in Vienna in 1976 as family business by the pharmacists Karin and Gerhard Prince. Today, CROMA-PHARMA is a global player in minimal-invasive aesthetic medicine. The company distributes its products in more than 70 countries and over a network of 12 company-owned sales organizations as well as through strategic partnerships and sales companies.