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System-based inspection approach ERES Requirements from global regulatory agencies EU GMP Annex 11: Computerized Systems •Materials management •Plant maintenance •Production planning •Production planning for process industries •Quality management •Sales and distribution •Logistics execution •Environment, health, and safety •Human resources and training information •Warehouse management Central functions include: •Batch management •Handling unit management •Document management Cross-application components include: •Engineering change management •Classification •Document management •Electronic records (audit trail) •Digital signature •Notifications •Records and case management •Master data governance
Electronic records: •Configuration within the implementation guide •Transports and business configuration sets used to migrate configuration from one software system to another •Master data such as the material master, vendor, resource, recipe, and customer •Business processing objects such as purchase orders, process orders, and inspection lots •Electronic records for business processes or transaction execution, such as material documents •Electronic or digital signatures Validation approach to achieve compliance: roles •Make-to-stock, make-to-order, engineer-to-order / projects •Assembly / configure-to-order / variant production •Supply chain management process integration •All mixed-mode types
Benefits of Beas Manufacturing: •Above-average functional industry coverage and process support •Quick, effortless and cost-effective implementation. Industry specifics are considered, integrated and available from the very outset. •Best-practice process, including options for easily and flexibly modifying or adding integrated business scenarios to meet your individual business requirements/typologies across all process chains. •Transparent process analyses (“inside views”) support companies in continuously reviewing the effects of optimization projects (such as lean manufacturing, improving product margins, etc.) using defined KPIs •Use and integration of the latest technologies and innovations, from SAP ERP certified integration to SAP HANA and analysis applications, as well as SAP cloud and mobile solutions.
Beas White Paper for regulated industries |