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 EPP 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 challenges of today and tomorrow’s world.

Common Challenges

Disparate Systems

When organizations run different systems — for manufacturing, procurement, finance, compliance and people — it’s inefficient, error-prone and costly. Figures from different systems rarely match, so management lacks a definitive version of the truth with which to make decisions.

Supply Chain Pressure

Companies need to maximize efficiency among networks of often far-flung suppliers, while reducing costs and improving responsiveness. When governments cut project budgets, only the most efficient supply chains can do so while maintaining profitability.

Cyber Security Regulations

Companies are seeing higher demands for compliance and auditability under DFATRS and ITAR and may face criminal or other penalties if they fall short. The stakes are immense for companies meeting the fast-paced challenges of today and tomorrow’s world.

    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

    VistaVu took a proven SAP cloud-based solution, adopted by over 94,000 users worldwide, and developed an add-on package that enables FDA CFR 21 Part 11 and EU Annex 11 compliance. With digital traceability through electronic signatures and process controls, compliance is met at significantly lower costs and with a satisfying reduction in headaches. Combine the powerful benefits of the cloud application with the IT cost savings and your company has gained an incredible tool to connect your entire operation with best-in-class processes, embedded analytics and 24/7 support. Schedule a consultation for more information – we’re nice people.

    Download this FREE Whitepaper

    Learn how VistaVu and this leading ERP system enable companies to meet FDA 21 CFR Part II 8 EU Annex 11.

     

     

     

     

    SAP Qualified Partner Package Solution for the Life Sciences Industry

    More than ever, companies in the Life Sciences industry need stronger operational strategies and systems to maintain their competitive advantage. Solutions such as strengthened supply chain management and identification will allow these companies to reach their fullest potential. Benefits of our Solution Include:

    • SCM and MRP
    • Distribution
    • Production
    • Project Management
    • Finance, Accounting and HR
    • Business Analytics
    • Electronic Signature
    • Inventory Management

    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.

    Common Challenges

    Disparate Systems

    When organizations run different systems — for manufacturing, procurement, finance, compliance and people — it’s inefficient, error-prone and costly. Figures from different systems rarely match, so management lacks a definitive version of the truth with which to make decisions.

    Supply Chain Pressure

    Companies need to maximize efficiency among networks of often far-flung suppliers, while reducing costs and improving responsiveness. When governments cut project budgets, only the most efficient supply chains can do so while maintaining profitability.

    Cyber Security Regulations

    Companies are seeing higher demands for compliance and auditability under DFATRS and ITAR and may face criminal or other penalties if they fall short. The stakes are immense for companies meeting the fast-paced challenges of today and tomorrow’s world.

    Benefits

    • 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

    VistaVu took a proven SAP cloud-based solution, adopted by over 94,000 users worldwide, and developed an add-on package that enables FDA CFR 21 Part 11 and EU Annex 11 compliance. With digital traceability through electronic signatures and process controls, compliance is met at significantly lower costs and with a satisfying reduction in headaches. Combine the powerful benefits of the cloud application with the IT cost savings and your company has gained an incredible tool to connect your entire operation with best-in-class processes, embedded analytics and 24/7 support. Schedule a consultation for more information – we’re nice people.

    Download this FREE Whitepaper

    Learn how VistaVu and this leading ERP system enable companies to meet FDA 21 CFR Part II 8 EU Annex 11.

     

     

     

     

    Your business has unique challenges and opportunities. We’re here to help sort those out and find the best solution. Contact our Aerospace & Defense Account Executive by clicking on the contact button above to send an email or call him for a quick 10-15 minute chat.

    Dennis Atwood
    Account Executive

    Toll-Free: 1-888-480-2727 x 553
    dennis.atwood@vistavusolutions.com