Solution of the FELTEN group can preset functions and workflows quickly used a PILOT E-HV be taken into account the GMP requirements for the process industry Serrig, 02.11.2010 – the FELTEN group has developed a best practice solution for the digital use of manufacturer regulations (HV) with PILOT E-HV for the process industry. It complies with the GMP requirements and includes all necessary functions to create, perform and evaluate the manufacturer regulations electronically. At the same time, the solution contains predefined workflows are created considering the established procedures in the process industry. You control and monitor all functions and processes of the module in the application. Pilot E-HV master batch records can in the system are individually defined and managed or imports of layered systems such as ERP, recipe ureditoren etc.. Further processing is generally not required, but can be optionally via equivalent rights mappings. The Displays the employee in question during gradually on the screen individual statements of a manufacturer regulation.
The system then guides him through every step of the process. The evaluation takes place online when entering the values. The system checks immediately and gives the user the corresponding information. There a deviation determined by the target values, which require a further consent, the double launches check function of the solution the solution automatically on a defined workflow. It serves the subsequent editing or correcting a defectively executed process step by a suitably qualified staff. The double function can check but carried also without deviation, enabling the user to one or more HVs. The closed regulations of the manufacturer are automatically archived in a historical directory.
This data can be accessed in accordance with the GMP regulations for a tracking & tracing at any time. It is also possible to report all HV Activities including deviation processing create to let. Because the module PILOT E-HV is based on field-proven features and pre-set workflows for the process industry, it can be without significant adaptation effort and thus cost-effective inserted”, describes Werner Felten, CEO of the software company, a key advantage of the solution. FELTEN group: The FELTEN group is an international operating software and consulting company, the solutions to optimise processes for all production areas and according to international quality standards of GMP and FDA (21CFR part 11) developed. Clients include Beiersdorf, Boehringer Ingelheim, Symrise, Sensient, Texas instruments, etc. FELTEN has become the first supplier the holistic and process-oriented production intelligence approach. The company is present except in German-speaking Europe in the United Kingdom and France.