Corden BioChem GmbH, located in Höchst near Frankfurt, is one of the world’s largest industrial production partners for biotechnologically manufactured products for the food and feed industries and for buyers of technical enzymes. Corden BioChem is a company of the ICIG Group. Corden BioChem now relies on the regulatory compliance expertise of DHC Business Solutions for the implementation of an integrated quality management system.
Transition and complexity reduction in SOP and training management
As of April 1, 2016, the ICIG Group of Companies acquired Sandoz Industrial Products GmbH, formerly a Novartis Group company, which now operates as Corden BioChem GmbH. The acquisition entails extensive changes in the company, which also affect the IT systems: The previous applications for SOP and training management can no longer be used; the “cut over” has been carried out. In addition, there is a requirement to combine the separate processes for SOP creation and management on the one hand and the subsequent training management on the other in an integrated solution. This replaces the previous systems, a Lotus Notes application and a custom development.
Quality management at Corden BioChem is thus undergoing a comprehensive transition: Step by step, numerous SOPs are transferred to DHC VISION; annoying media breaks are avoided; error-prone duplicate work is eliminated through the use of integrated management software.
FDA compliance through more transparency in SOP training
It is worth noting: 95% of training at Corden BioChem is induced by SOPs. This not only covers the regulations of the pharmaceutical industry; Corden BioChem also has to consider the standards of food production. This highlights the importance of easy-to-use SOP and training processes – and the importance of detailed information about training processes and successes.
Here, too, the strength of the SOP and training management in DHC VISION is evident: All activities, state changes and results from training and certification are documented in detail and throughout the entire training process. In this way, different regulations can be complied with, taking into account not only SOPs but also other types of documents. At the same time, maximum transparency is achieved: You can see which employees have which training status for which training items and topics, where there may be gaps, and what actions are needed. An accurate picture of the state of training in the organization emerges, differentiated by groups, roles, or employees, and with appropriate messages about courses of action and measures that may need to be taken.
Control of learning success through interactive tests
Corden BioChem aims to not only meet, but exceed the high standards for documentation and traceability of SOP training processes. For this purpose, the company uses the interactive SOP control of learning success in DHC VISION: Online tests with different types of questions and tasks are used to check whether employees have understood the content of an SOP. At the same time, test results are used to assess whether employees are able to transfer their knowledge into practice. Employees receive clearance only if they achieve a minimum score on the test and the software generates an audit-proof certificate for this. Online tests thus go far beyond what can be achieved with simple read receipts. They also create transparency in the training process and therefore play a key role in compliance-relevant certification workflows.
Smart validation for FDA and GxP compliance
GxP-relevant software systems must be validated. To keep the validation effort manageable, Corden BioChem uses the “DHC VISION Validation Accelerators”. These are templates and process models for all essential steps of 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.
“We decided on DHC VISION because we were convinced by the compactness of the system and the synergy potential of the integrated quality management solution,” emphasizes Maik Simon at Corden BioChem GmbH and responsible system owner for DHC VISION. Maik Simon adds: “Decisive for our decision were also the validation expertise of DHC and last but not least the recommendations and references of other companies in the chemical and pharmaceutical sector“.
“Our customers confirm the increasing relevance of GxP-compliant processes and documents in all conceivable forms,” explains Dr. Wolfgang Kraemer, Managing Director at DHC Business Solutions. “Regulatory requirements for the creation, management and steering of SOPs are also rising sharply, especially in the context of Industry 4.0 and Quality 4.0. Our product and innovation strategy therefore focuses on the simplification and sustainability of business-critical processes; our concern is greater efficiency during implementation, but also in ongoing operations. We look forward to working with Corden BioChem to meet these challenges in the future.”
About Corden BioChem:
Corden BioChem GmbH offers contract development and manufacturing (CDMO) of microbial fermentation, technical enzymes and application of biocatalysis. With fully controlled facilities, e.g. fermentation by means of process data acquisition and monitoring, Corden BioChem GmbH has expertise in the development and large-scale production of immobilized enzymes with various carriers. For more information about Corden BioChem, please visit: www.cordenpharma.com.