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Medical Device Manufacturing

The medical device industry faces many challenges in terms of managing products along the supply chain.  Because companies work with vendors around the globe, they must project inventories, manage just-in time supply deliveries, and predict warehousing needs, all while maintaining specified levels of quality. In addition, companies must adhere to a host of regulations, including FDA Title 21 Code of Federal Regulations (CFR) Part 11 and Annex 11 for the European Union. Complying with such regulations appears to be keeping members of the C-suite up at night. A recent Emergo survey found that 66% of senior device executives are most concerned with regulatory changes that could affect their companies. As the survey noted, these concerns are not new and are coming as the international device market experiences rapid growth.The medical device industry faces many challenges in terms of managing products along the supply chain. Because companies work with vendors around the globe, they must project inventories, manage just in time supply deliveries, and predict warehousing needs, all while maintaining specified levels of quality.

Our solutions support quality planning, continuous monitoring and quick problem solving. They can support information sharing and control quality processes across the supply chain. Wherever your company is located, combining powerful ERP functionality with the cloud should prove transformative by eliminating costs associated with IT staffing and software maintenance, improved operations and security, and enabling mobile access anytime, anywhere. The savings resulting from adopting such a platform could be invested in other areas (including R&D) to help medtech manufacturing and distribution companies meet the fast-paced chaIIenges of today and tomorrow’s world.

 

Business Benefits

  • Establish QMS practices
  • Establish QMS practices
  • Demonstrate Compliance
  • Manage Risk
  • Configurability to meet departmental requirements
  • Real time business intelligence
  • Ability to streamline business processes

Pharmaceutical Manufacturing

The pharmaceutical manufacturing industry is undergoing fast paced change in a highly competitive and regulated environment. As pharmaceutical manufacturing companies and contract manufacturing organizations (CMOs) mobilize to produce new drugs, improve and accelerate manufacturing processes, and manage their growth across national and international organizations – the complexities of their businesses are growing throughout their entire supply chain. The responsibility of managing the quality of their products is foremost, along with the challenge to remain compliant on multiple regulatory levels – all while growing a successful financial and operational corporation.

Business Benefits

  • Ensure delivery of high quality results (product/processes) on time and on budget
  • Ensure delivery of high quality results (product/processes) on time and on budget
  • Scale operations for growth to produce new products, increase sales and meet demand
  • Trace -ability: maintain compliance with strict government and regulatory requirements
  • Effectively manage forecasting, planning, processes and inventory
  • Maintain operational visibility and track key performance data
  • Reduce operational costs