SYSPRO for the Medical Industry

Medical device manufacturers today are faced with the challenge of complying with stringent standards in quality, safety and traceability and, accordingly, must provide documentation to substantiate procedures.  However, the potential advantages of electronic solutions still eludes many of the small and mid-size medical device manufacturers which are still clinging to outmoded paper trails to show compliance

Industry observers, however, believe that it is very likely that the FDA will require electronic solutions in the not-too-distant future.  What’s more, they believe that these changes will not only facilitate a company’s ability to show FDA compliance, but will also enable market laggards to gain billions of dollars in revenues by leveraging technologically superior software.

Faced with the daunting task of complying with U.S. FDA QSR and GMP requirements, as well as European medical device and active implantable medical device directives, medical device companies must provide a high degree of assurance that their devices and the processes used to manufacture medical products meet specific requirements as well as user needs.

SYSPRO is dedicated to making it easier for its customers to analyze, plan and manage every aspect of the enterprise at every stage in the manufacturing process. Moreover, the SYSPRO solution enables real-time visibility into the supply chain to address complete requirements, including: complex manufacturing environments, material controls, supply and demand, lot and serial number tracking, and material and production optimization. SYSPRO enables your path to success with a complete, integrated solution that meets your system and regulatory requirements and delivers outstanding value based on exceptional price, performance and functionality.

Streamline regulatory compliance

SYSPRO saves you time and money by enabling you to complete the FDA and ISO system validation process as part of the SYSPRO system implementation and ongoing utilization. The integrated document management and role based security features allow you to track audit-related documentation and expedite approval processes while meeting the FDA’s standards for electronic records and electronic signatures under 21 CFR Part 11. In fact, multiple triggers can be associated with one transaction, allowing for multiple actions or activities to be initiated. Conditional logic can also be associated with each trigger, thus extending business processes and facilitating management by exception.

SYSPRO supports the requirements of 21 CFR Part 820, Quality System Regulation, including:

• Change control design, purchasing, and part expiration controls.
• Integrated warranty, service management, quality management, and complaint tracking.
• Full lot and serial number traceability with complete component to parent tracking
• Device master records (DMRs), device history records (DHRs), and quality system records (QSRs). 

In addition, SYSPRO makes it easier to comply with governance laws such as the Sarbanes-Oxley Act in the United States.

Monitor customer satisfaction
SYSPRO integrates enterprise resources planning (ERP) and customer relationship management (CRM), allowing your sales and service people instant access to information on customers, devices, service contracts and spare parts. SYSPRO (CRM) lets users track and manage all customer and supplier touch points. The extensive knowledge base can be utilized to address complaint tracking, resolving and analyzing customer concerns, internal quality issues and corrective action issues in order to achieve total customer satisfaction.

Industry Knowledge

SYSPRO’s commitment to meeting industry demands of medical device manufacturers as well as distributors can be seen in its comprehensive product offering. For example, to guarantee product safety compliance, SYSPRO provides a paperless automatic routing and approval process for all engineering changes. Lot and shelf life expiration controls ensure against consumption or shipment of expired materials. SYSPRO tools enable customers to be associated with buying groups to handle rebates and promotions. Requirements planning and Distribution methodologies is instrumental in helping to plan for realistic purchasing and production schedule, optimize stock holdings and transfer of materials to optimize the movement of inventory to satisfy demand. Returns allow for the facilitation of after sale service and support of products, and managing warranty tracking, service calls and returns and repairs. Through Asset Management the entire life cycle of an asset from planning and installation to preventative maintenance and repair, can be controlled and monitored. SYSPRO manufacturing allows customers to track production with material, labor and costing with visibility across the enterprise to ensure products are manufactured and delivered according to regulatory standards. In addition, SYSPRO’s support for Lean manufacturing, within the enterprise and extending to the supply chain, enables build-to-order and JIT manufacturing, reducing inventory and its related costs and facilitating the communication of changes in customer demand.

Cutting Edge Technology

SYSPRO component-based architecture is designed to provide a highly cost-effective way for customers to integrate best-of-breed applications, maximize business-to-business trading and leverage wireless connectivity. It also provides the framework for a new generation of Web-based applications. The applications developed using the Microsoft .NET architecture is fully customizable to meet customer requirements.