Allessa GmbH is one of the leading contract manufacturers of organic intermediates and specialty chemicals. Allessa now relies on the regulatory compliance expertise of DHC Business Solutions for the introduction of company-wide standardized quality management software .
Digital Transformation in SOP and training management
The management of Standard Operating Procedures (SOP) and GMP-relevant documents often involves an immense administrative effort. This is because it is not uncommon for the steering process to still be largely paper-based and essentially manual. This is not without risk, because despite all due care, there is a risk that compliance regulations are not always adhered to. And this has consequences: If, for example, a reading and understanding certificate or a training certificate for an employee is not FDA-compliant, he or she is not even allowed to operate the production plant. This might result in production losses. Nor does it make employee scheduling any easier.
This is where the “digital transformation” in quality management comes in: Step by step, SOP processes and workflows are digitized; efforts and risks in SOP and training management are reduced; and annoying media breaks as well as error-prone duplicate work are eliminated by using integrated management software.
DHC VISION for digital management processes
Training measures must be precisely planned, carried out, documented in a comprehensible manner and stored in a way that can be checked in detail. These are compliance requirements that absolutely must be met. This is also the case in SOP management. Here, too, high standards apply to the documentation, transparency and traceability of the processes.
The DHC VISION SOP and Training Management provides just that: All activities, state changes, and results from employee training and certifications are documented in detail and throughout the training process. This ensures compliance with internal and external regulations. At the same time, maximum transparency is achieved: It becomes clear which employees are in which training status for which training items (e.g., SOPs) and topics, where gaps may exist, and what possible actions need to be initiated. An accurate picture of the state of training in the organization emerges, differentiated by groups, roles, or employees, and with corresponding indications of courses of action and measures that may need to be taken.
For such monitoring of SOP and training management processes, Allessa uses DHC VISION Analytics Dashboards. They comprise the essential KPIs from the SOP Life Cycle and provide the necessary early warning signals by selecting and condensing crucial information.
Smart Validation for FDA and GxP compliance
Software systems relevant to GxP must be validated. To keep the validation effort manageable, Allessa 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.
“The decision to work with DHC Business Solutions was made because we were convinced by the combination of comprehensive industry expertise, lean but powerful validation processes and the integrated software solution DHC VISION.”, emphasizes Dr. Ottmar Wink, Director Analytics at Allessa GmbH. “These are real unique selling points of our new partner”. And Rolf Knöpfler, who is responsible for system management and quality assurance at Allessa GmbH, adds: “We expect the digital transformation that has now been initiated to result in a quantum leap for quality management at the various locations of our group of companies.”.
“Digital transformation processes in the regulated environment require great care and foresight in their planning and implementation”, adds Dr. Wolfgang Kraemer, Managing Director at DHC Business Solutions. “DHC’s many years of experience in the industry are an added value for customers, especially in terms of efficiency and speed of implementation – and not least the quality of the results achieved”.
Allessa GmbH (formerly Cassella GmbH), headquartered in Frankfurt/Main-Fechenheim, is the sales and administration company of the Allessa companies in Germany. At the same time, it is the operator of the Frankfurt-Fechenheim Industrial Park and thus a service partner for manufacturers of chemical intermediates and specialty chemicals, in particular Allessa Produktion GmbH. Allessa GmbH’s services include analytical services, research and development, technical services and solutions, and the full range of administrative support such as quality assurance, controlling, supply chain management, purchasing and human resources.
You can find more information about Allessa GmbH at www.weylchem.com