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SAP R/3 QM: managing packaging specifications
Project duration: 1 year, 1 month
Brief description
Leading project supervision on the part of SAP first level support. As part of this project, a system is developed that is able to map packaging specifications while fulfilling the GMP requirements with quality control plans from the QM (quality management) module.
Supplement
Support for the specialist department and handling the software change management within the QM module for a validated SAP system, which is used in the production of medication (parenterals). Packaging specifications are used by the customer to provide its suppliers of packaging materials (e.g. folded boxes, cut-outs, inserts, labels) with legally binding requirements regarding how the packaging is to be procured. The quality control plans from the QM module are created and changed with the help of the change service, in order to implement version-controlled management with workflow-controlled signature circulation in the system. The individual information that makes up a quality control plan is based on modules (master inspection characteristics). These modules may be automatically generated by the system for data from the material master when the quality control plan is created, in order to ensure that they comply with the material master data that is currently valid.
Subject description
Interface between the specialist departments and the programming in a project to transfer a function from an MES individual system (Manufacturing Execution System) that is to be replaced by quality control plans in SAP R/3. Developing the requirements for a new system for managing packaging specifications with the specialist department, and the correct handling of the project via the customer's validation formalism. This includes organizing the project meetings, creating most of the validation documents and manuals, as well as identifying and preparing data from the old system. When packaging is ordered, the purchasing department can automatically fax the applicable version of the associated quality control plan together with the ordering document, from SAP to the customer.
Overview
- Industries pharmaceutical industry
- Specialist tasks FDA validation, packaging, quality management
- DV tasks standard software development
- System environment standard software: ERP systems
- Procedure model Summit-D (PwC)
- Databases Oracle Database
- Operating systems Unix
- Standard software SAP R/3 MM, SAP R/3 QM
Project period01.07.2004 - 31.07.2005
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
Service
Industries
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