Syspro ERP software firm K3 Business Technology Group is increasing its focus on the medical and healthcare products manufacturing markets.
K3 managing director Howard Joseph says the system is now equipped to handle US FDA (Food & Drugs Administration) compliance, and can help manufacturers to comply with the UK Medicines and Healthcare products Regulatory Agency (MHRA) regulations.
“Existing business processes often require re-engineering to meet these requirements,” he observes. “However, by far the most critical element required to meet regulatory requirements is the effective use of ERP systems.
“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.”
He cites in particular Syspro ERP Return Merchandise Authorisation (RMA) and Syspro Return to Vendor (RTV) modules as helping users to manage quality through product tracking – with the software automatically generating RMA/RTV documents indicating reasons for return and/or exchange.
Joseph also highlights the Syspro ERP Engineering Change Control (ECC) module, which, he says, can enhance or replace the usual paper trail. “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,” says Joseph.
“Syspro ERP functionality, including RMA/RTV, Engineering Change Control, Electronic Signatures, Product Configurator, Lot and Serial Tracking, Report Writer, Business Analytics and reporting capabilities, are reasons why many healthcare product manufacturers are turning to K3,” he insists.
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