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K3 Business Technology Group, a leading enterprise business software company, has announced that SYSPRO ERP offers the required functionalities to assist medical and healthcare products manufacturers in meeting stringent regulations.
The latest software aids compliance with the United States FDA (Food & Drugs Administration) corporate regulatory compliance, as well as assisting companies in the UK to become compliant with the Medicines and Healthcare products Regulatory Agency (MHRA) regulations. Furthermore, SYSPRO ERP can support evaluation of suppliers, maintain quality records and enable traceability.
Meeting stringent healthcare product manufacturing requirements is an essential strategic business objective for manufacturers. Existing business processes often require re-engineering to meet these requirements. However, by far the most critical element required to meet regulatory requirements is the effective use of ERP systems, said Howard Joseph, Managing Director, K3 Business Technology Group, said: Our pharmaceutical industry customers have been successful in meeting strict requirements as a result of the embedded functionality that SYSPRO ERP provides for facilitating compliance.
SYSPRO ERP Return Merchandise Authorization (RMA) and SYSPRO Return to Vendor (RTV) software modules are helping manufacturers manage quality by tracking returned or exchanged items. The software automatically generates RMA/RTV tracking documents indicating the reasons for the return and/or exchange. The documents are linked with cross-shipments, repair jobs, inventory and credit controls as well as invoices and credit notes to provide investigative pathways. By defining and applying customised RMA codes, trends can be ascertained and analysed for quality control purposes and compliance.
The SYSPRO ERP Engineering Change Control (ECC) module is also helping manufacturers comply with regulations. The ECC process is a user-definable workflow type ERP sub-system. This can enhance or even replace the paper trail that usually accompanies any changes to product design data. By providing mechanisms, audit trails and archives, the ECC gives manufacturers ready access to documentation on prior product versions. In this manner, the manufacturer has the ability to address questions relating to product defects in older product versions.
Comprehensive ECC documentation also enables manufacturers to easily revert to the production of prior product versions, if necessary, to suit the requirements of a particular customer or conform to regulations.
Regulated manufacturers have long embraced ERP and CRM solutions. While they have used these to achieve operational efficiencies as well as sales and marketing objectives, these manufacturers have also discovered that their ERP and CRM systems can assist them to comply with MHRA and ABPI requirements. SYSPRO ERP functionality including RMA/RTV, Engineering Change Control, Electronic Signatures, Product Configurator, Lot and Serial Tracking, Report Writer, Business Analytics and extensive reporting capabilities are reasons why many healthcare product manufacturers are turning to K3 Business Technology Group, concluded Howard Joseph.
About K3 Business Technology Group
K3 Business Technology Group employs 90 people at its Manchester head office and its branches throughout the UK and Ireland. The company offers solutions in enterprise resource planning (ERP), customer relationship management, advanced planning and scheduling, warehouse management, human resources and e-business. SYSPRO is used by some 12,000 sites across the world. K3 Business Technology Group is part of K3 Business Technology PLC which is a global leader in providing next-generation enterprise software for businesses in the retail, manufacturing and distribution sectors. With more than 3,000 customer installations in over 30 countries, K3 is recognised as a safe, innovative and reliable provider of world-class solutions, backed by world-class service.