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.
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.
- 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.
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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
- 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…