MAXLife for Microsoft Dynamics AX gives Pharmaceutical manufacturing companies the tools needed to control costs while paying close attention to government regulations and current Good Manufacturing Practices (cGMP). MAXLife enables these companies to efficiently manage shelf life constraints, cost pressures, competition from generic and over-the-counter drugs, and strict regulatory requirements around manufacturing and product approvals. With integrate capabilities to meet regulatory requirements such as FDA 21 CFR Part 11, Sarbanes-Oxley (SOX) Compliance, Good Manufacturing Practices (cGMP), the Bioterrorism Act, and Hazard Analysis & Critical Control Points (HACCP), MAXLife enables pharma manufacturers to produce and ship the right product, at the right time, in full compliance with regulatory requirements.
- Quality Control
- Lot Traceability
- Recall Procedures
- Bin Management
- Audit Trails / Electronic Signatures
- … and more!
Support for Good Manufacturing Practices (GMP) and Regulatory Compliance
Microsoft Dynamics AX for Pharmaceutical companies supports cGMP requirements including electronic quarantines, quarantine release by user and material type, printed material control/obsolete components, lot control/segregation, lot tracking, and drug and hazardous reconciliation. The solution documents standard processes, and tracks and logs operations and results to support your detailed reporting requirements. For pharmaceutical companies, features such as traceability, lot tracking and traceability, production statistics reporting, specification management and change management provide the control and predictability you need to detect and address exceptions early, and consistently produce the highest quality products. By tracking items from cradle to grave, your company can implement effective recall procedures with complete forward and backward traceability of any material.
Optimize Manufacturing Resources to Expedite Profitable, New Product Introductions
With development costs approaching $800 million for each new product, pharmaceutical companies constantly strive to bring products to market quickly, while controlling costs by monitoring operations at a detailed level, keeping a close watch on yields and labor, tracking raw material usage, and planning production shifts to maximize capacity. MAXLife provides visibility across all areas of your organization from finance to manufacturing, speeding the flow of goods, eliminating waste due to costly shelf-life expirations and returns, optimizing production operations, and delivering increased efficiency to meet new product introduction demands, while keeping costs at a minimum.
Improve Production Planning and Inventory Management
Pharmaceutical manufacturers handle active ingredients that are often very expensive in small quantities so they are often reused and/or recycled several times. Microsoft Dynamics AX models the processing and reprocessing of such materials. It also helps minimize over-runs and short-runs, and uses shelf-life tracking to take expiration dates into consideration during production and into the distribution process. You can also centrally manage co-products and by-products in your formulas or recipes and always know the correct inventory status for any given item.
