Medical Device Manufacturing
The medical device manufacturing 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 manufacturing 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 medical device manufacturing and distribution companies meet the fast-paced challenges of today and tomorrow’s world.
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.
- Establish QMS practices
- Demonstrate Compliance
- Manage Risk
- Configurability to meet departmental requirements
- Real time business intelligence
- Ability to streamline business processes
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.
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.
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Learn how VistaVu and this leading ERP system enable companies to meet FDA 21 CFR Part II 8 EU Annex 11.
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Learn how VistaVu and SAP Business ByDesign for MedTech Manufacturing Enables Companies to Meet Compliance and QA Requirements for FDA 21 CRF part 11 and EU Annex 11
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Introduction to SAP Business ByDesign For Manufacturing
Reduce Costs with SAP Cloud ERP for MedTech
We’ve taken a world-class, proven ERP cloud solution and added on a pharmaceutical manufacturing package. The results are a cost-efficient system that deploys In a shorter time frame and enables your company to:
- Ensure delivery of high quality results (products and processes)
- Easily expand into new markets
- Manage customer demand with robust forecasting. planning, processes & inventory management
- Deliver a real time, integrated customer view of your business enabling the right decisions – faster
- Meet necessary regulatory compliance with trackable & traceable, digitally-managed documents
- Avoid additional IT costs and reduce operational Costs
- And more…