Manufacturing Execution System (MES) for Medical Device Manufacturers

ToolTrack MES: Your Medical Device Manufacturing Solution

Medical device manufacturers require product innovation and new product revenue like no other industry, as well as a high degree of manufacturing control and flexibility across plants that may be distributed across geographical regions. It is imperative to match operations across facilities, sustain yield improvements and buffer supply chain response to late-stage demand changes. I-Track Software's solution for medical device manufacturers meets these challenges while reducing time to market, ensuring consistent quality across production sites and simplifying the process of regulatory compliance.

Time-to-Market Advantage

Take the example of re-certifying changes to a manufacturing process and the necessary supporting information systems. ToolTrack MES adapts to a variety of product configurations, enabling organizations to rapidly test, implement, adapt, and re-certify changes in-house on your schedule. This flexibility supports customer specific processes and products without requiring re-validation of the MES. Standardized process definition and management can substantially increase yield and make it possible to quickly increase volume by ramping up new and existing processes. ToolTrack MES is the comprehensive solution that delivers this real-time adaptability to quickly optimize production processes across multiple unique manufacturing sites.

Simplify & Reduce the Cost of Regulatory Compliance

ToolTracks MES includes functionality specifically designed to help medical device manufacturers comply with current and emerging regulatory requirements reducing the cost of compliance while improving efficiency and providing full accountability. ToolTrack MES complies with FDA Regulation 21 CFR Part 11 governing electronic signatures and the collection and storage of electronic records. In addition, ToolTrack MES supports good manufacturing practice required by 21 CFR Part 820 with real-time batch history and genealogy which ensures the integrity of the manufacturing audit trail by accurately tracking material and production activities across different sites, time zones and geographies.

Ensure Quality with Complete Traceability

ToolTrack MES supports creation of complete device history records (DHR) that include operator, equipment, date & time, process recipes / work instructions, consumable information and quality data. Corrective and Preventive Action (CAPA) and Statistical Process Control (SPC) with automated alerts enable rapid resolution of manufacturing issues before they become problems in the final product. In addition, central management and distribution of workflows and specifications reduces manufacturing variability across facilities and improves quality throughout the global production network.

Why I-Track Software?

We provide a flexible solution that fits your operations and grows as you do. This enables your production supervisors, engineers and managers to adjust to the ever-changing manufacturing processes. ToolTrack MES was built by manufacturing industry experts - who won't pass your requirements to an offshore development team - who build your solution using a modular platform where customizing details is easy, quick and less expensive than any other product on the market. You always get unlimited users and your team can create as many custom reports as they need without knowing how to code! I-Track Software allows you to move away from costly legacy systems that lack the flexibility to adapt to changing business requirements, to a solution that gives you a competitive edge.

How Does I-Track Software Do This?

We've taken a different approach to Manufacturing Execution (MES) and shopfloor control software. Most companies use a legacy architecture with rigid database and application layers which limits the ability for customization. These products often require full time in-house support and slow thin client programs that have to be constantly updated and won't run on mobile devices. But with ToolTrack MES customization is driven by metadata rather than low level source code. Plus, ToolTrack MES utilizes a fast web-based user interface so you can access it anywhere, on any device.

The flexible modeling and extensive configuration options in ToolTrack MES allow your manufacturing software to be quickly tailored without expensive programming. Multiple facilities can maintain a level of autonomy while leveraging a single MES solution. If custom program logic is needed, the new functionality can be implemented once and be immediately available to all users without disrupting operations or re-certifying the application.

ToolTrack MES Benefits

Shorten cycle times while ensuring quality and predictability.
Handle changing product specifications without loss of production time.
Tracks off-site / contract manufacturer work so you can predict throughput and relieve bottlenecks.

Manage equipment utilization, reducing scrap and increasing yields.
Shorten New Product Introduction (NPI) times by isolating pilot runs and providing intuitive access to quality monitoring data.
Maximize resources through controlled training & certification.

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MEDICAL DEVICE MANUFACTURING SOLUTIONS