As a result of numerous mergers and acquisitions and increased competition through industry globalisation life sciences is experiencing a period of major change. With the added challenges of stringent manufacturing processes, rapid advances in science and technology and ever changing environmental laws and regulations, companies operating in this sector are under pressure to accelerating growth and reduce time-to-market while continuing to produce high quality product.
Internal efficiency and effective business procedures have become vital to future success and competitive advantage. Microsoft Dynamics AX, a fully integrated state of the art business solution provides a robust flexible platform to continually improve business performance. We recognise the need for systems that allow materials to be tightly regulated from initial receipt, through production and shipment to customers. Our clients include vaccine, biological, pharmaceutical and nutritional manufacturing, packaging and distribution companies.
Key features
• User signature (FDA 21 CFR Part 11)
• Quality management
• End to end batch traceability
• Shelf life management
• Approved vendor management
• Packaging variations
• Multiple units
• GMP, FDA and regulatory compliance
• MSDS
• Compliance management
• System validations (IQ, OQ, PQ)
With Microsoft Dynamics AX you can you cut through this complexity with a proven way to integrate and streamline all your business and manufacturing processes.
Microsoft Dynamics AX provides a suite of practical business modules which can be tailored to your needs today – and tomorrow.
FDA Toolkit for Microsoft Dynamics AX
The Microsoft dynamics FDA Validation toolkit is designed to complement Dynamics AX in assisting life sciences companies to achieve and maintain Food and Drug Administration (FDA) validation.
Templates included:
• Validation Master Plan (with risk assessment)
• Software Plan
• Requirements Disaster Recovery
• Software Traceability
• Validation Test Plan
• Supplier Audit Check List
• Internal Procedures
• Signature Matrix
• Validation Standard Operating Procedures
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Validation Summary Report