Allessa GmbH is one of the leading contract manufacturers for organic intermediate products and specialty chemicals. The regulatory compliance expertise of DHC Business Solutions has convinced Allessa to implement DHC VISION as foundation for a company-wide digital quality management System.
Digital transformation in SOP and training management
Managing Standard Operating Procedures (SOPs) and GMP-critical documents is intricate and involves a high volume of administrative work. However, quite often document control processes still are paper-based and managed manually. This is not without risk: Despite of all accurateness, it is hard to always comply with all rules and regulations that apply. This may have consequences for the entire production process: In case there is no FDA-compliant evidence of an employee having received proper training or having read and understood key instructions, he or she may not be allowed to operate a production facility. This may result in production downtime and bottlenecks in staff planning.
This is what the “digital transformation” in quality management is trying to avoid. Step by step digitization of SOP processes and workflows aims at reducing complexity, costs, and risks in SOP and training management; an integrated management software avoids awkward media breaks and error-prone duplication of work.
DHC VISION supports digital management processes
Regulatory compliance requires detailed planning and implementation as well as verifiable documentation and archiving of training measures. Similar requirements apply to SOP management. High standards for documentation, transparency, and traceability of processes apply.
DHC VISION SOP and Training Management does just that: Activities, status changes and events related to staff training and certification processes are documented in great detail. This is to comply with internal and external regulations. At the same time, it secures high levels of transparency: At any point in time is it possible to capture the status quo in staff training, i.e. to see who is receiving what kind of training, to identify training gaps, and to verify on measures that need to be taken to close such gaps. The software is able to show a detailed picture of the current state of affairs in training management; it renders a differentiated view on groups of staff, staff roles, or individual staff members and provides information on options for actions and measures to take.
Allessa monitors SOP and training processes using DHC VISION Analytics dashboards. Dashboards cover core SOP life cycle KPIs and give early warning signals via selection and aggregation of key information.
Smart validation for FDA and GxP compliance
To demonstrate GxP compliance, software systems need validation. To reduce validation costs, Allessa uses DHC VISION Validation Accelerators, i.e. a set of templates and process models for all steps of the validation process – from validation plan to Part 11 analysis, specification of user requirements (URS) and test case definition to the final validation report. Such templates are at the center of DHC’s process- and risk-based validation approach, which figures prominently in the chemical and pharmaceutical industries as it speeds up the validation process considerably.
“We decided to cooperate with DHC Business Solutions as we were convinced of the company’s unique blend of industry experience, lean but effective validation processes, and the integrated management software DHC VISION,” Dr. Ottmar Wink, Directory Analytics at Allessa GmbH, points out. “These are real USPs of our new partner.” And Rolf Knöpfler, responsible for system management and quality assurance at Allessa, adds: “From the digital transformation we have started we expect a quantum leap in quality management at all sites of our group of companies.”
“The digital transformation in regulated industries need careful planning and perspicacity in implementation,” Dr. Wolfgang Kraemer emphasizes. The Managing Director at DHC Business Solutions adds: “Our broad industry experience adds significant value to our services, in particular when it comes to efficiency and speed in project implementation – and the quality of its results.”
Allessa GmbH (formerly known as Casella GmbH) is located in Frankfurt/Main-Fechenheim. The company manages sales and administrative activities of all Allessa companies in Germany. It also manages the industry park Frankfurt-Fechenheim and acts as service partner to manufacturers of chemical intermediary products and specialty chemicals, in particular of Allessa Produktion GmbH. The company’s portfolio covers analytics services, services related to research and development, technical services and solutions as well as the whole range of administrative support services such as quality management, controlling, supply chain management, procurement, and HR.