SMBs in the pharmaceuticals industry are under increasing pressure to be first to market and face a challenging business mix. While meeting demand for faster drug development and production cycles, companies are obliged to keep a close eye on costs and observe increasingly stringent regulatory controls. Reducing time-to-market is key. SAP Best Practices for Pharmaceuticals – V1.470 helps pharmaceuticals SMBs to quickly take advantage of the latest SAP R/3 Enterprise functions for the pharmaceuticals industry. Pre-configured business scenarios for mySAP Business Suite systems and extensive documentation cover the most important mid-market requirements of pharmaceuticals companies – speeding up implementation, reducing costs, and giving pharmaceuticals SMBs the edge they need to go to market quicker.
With SAP Best Practices for Pharmaceuticals – V1.470, pre-configured business scenarios are available in all the familiar areas. As well as typical pharmaceuticals business processes such as manufacturing, quality management, or batch management, companies can exploit the potential of mySAP Customer Relationship Management, mySAP Supply Chain Management, mySAP Business Warehouse, or mySAP Supplier Relationship Management. In the traditional area of Enterprise Resource Planning (ERP), logistical processes for planning, manufacturing, and selling various dosage forms are covered – be it tablets, capsules or liquids. The main focus is on new SAP R/3 Enterprise functions such as browser-based process instruction (PI) sheets, digital signatures, electronic batch records, external subcontracting, material identification and reconciliation, as well as integration of an external weighing system.
New to the range of ERP scenarios is the ‘Stability Study’ scenario, which reflects the corresponding functionality offered in SAP R/3 Enterprise. Stability studies are compulsory in the pharmaceuticals industry and are used to track and analyze how different environmental conditions affect compounds or materials over a period of time. SAP Best Practices for Pharmaceuticals – V1.470 offers pre-configuration covering all of the steps involved in carrying out a stability study – from set-up and planning through to testing and completion of the study.
Speaking the lingo
Many machines operating at a process level in pharmaceuticals companies, for example, stirring or packaging machines, communicate using OPC* (* OPC stands for ‘Object Linking and Embedding [OLE] for Process Control’ and defines the data exchange within a Microsoft Windows environment). SAP R/3 Enterprise now speaks the lingo too and is able to exchange data via the SAP OPC for Data Access (SAP ODA) interface. SAP ODA is able to read and write values on an OPC data access server. In other words, SAP R/3 can use the OPC server to issue instructions to machines and, when required, react quickly to data it receives from the OPC server, issuing alerts and triggering prompt action via the SAP Alert Management function.
To make the most of these new capabilities, the ERP ‘Solid Dosage Forms’ scenario in SAP Best Practices for Pharmaceuticals has been extended to include SAP OPC for Data Access and SAP Alert Management. SAP Best Practices for Pharmaceuticals – V1.470 shows companies how to connect an OPC demo server to SAP R/3. This OPC demo server provides process data (for example, critical values), which can be called up in the appropriate phase of the process instruction (PI) sheet. Depending on the severity of the data received, alert messages can be sent in the form of e-mails or text messages to the relevant employee.
Making the grade
The pharmaceuticals industry is subject to strict regulatory requirements and drug manufacturing standards often extend to the keeping of electronic records. U.S. Food and Drug Administration (FDA) directives stipulate that all changes to business data on pharmaceuticals manufacturing have to be logged. These standards are laid out in the U.S. FDA Title 21 Code of Federal Regulations (21 CFR) Part 11 Electronic Records Electronic Signatures Final Rule. To help relieve pharmaceuticals companies of some of the burden of compliance, SAP developed a tool with an audit trail function (called FDA 21 CFR Part 11 Enhancement on Electronic Records). With SAP R/3 Enterprise, this tool is now standard issue and no longer delivered as an add-on. SAP Best Practices for Pharmaceuticals – V1.470 offers updated documentation on the tool and a technical building block, which shows how the tool can be configured. This includes a selection of transactions relevant for GxP-critical topics, change document objects, and associated tables.
How to order
Customers and partners can order the complete SAP Best Practices for Pharmaceuticals -V1.470 from the Software Catalog on the SAP Service Marketplace. For documentation only, orders can be placed in the SAP Knowledge Catalog. All SAP Best Practices versions are free of charge to SAP partners and customers.