ToolTrack MES: Your Biotech & Medical Device Manufacturing Solution

FDA audits don't wait for you to get your records in order. Medical device manufacturers operate under some of the most demanding regulatory requirements in any industry — 21 CFR Part 820, Part 11 electronic records, ISO 13485 — and every production step needs to be documented, traceable, and defensible. ToolTrack MES gives biotech and medical device manufacturers the control infrastructure to build compliant Device History Records (DHRs) automatically, enforce electronic signatures at critical operations, and maintain an unbroken audit trail from raw material receipt through finished device release. This isn't a compliance bolt-on — it's the production system, so there's no reconciliation between what was built and what was recorded.

Time-to-Market Advantage

Bringing a new medical device to market means managing overlapping product generations while keeping existing production in compliance. ToolTrack MES uses a metadata-driven process model, so new product routings, work instructions, and data collection steps are configured in the UI — not coded — and deploy immediately without re-validating the underlying MES platform. Your validation team qualifies the application once; process changes go through a controlled change management workflow that generates the documentation trail your quality team needs. The result is faster new product introduction, fewer change-related CAPAs, and a system that grows with your product portfolio without a new implementation each time.

Simplify & Reduce the Cost of Regulatory Compliance

ToolTrack MES is designed from the ground up for 21 CFR Part 11 compliance. Electronic signatures are enforced at configurable operation steps — no workarounds, no paper backup. Every record is timestamped, tied to a user account, and immutable in the audit log. For Part 820 and ISO 13485, ToolTrack captures the full production record in real time: operators, equipment IDs, process parameters, consumable lot numbers, inspection results, and non-conformance dispositions. When an FDA inspector or notified body asks to see the DHR for a specific serial number, you pull it in seconds — not days.

Ensure Quality with Complete Traceability

Forward and backward traceability is a core ToolTrack capability, not an add-on report. From any finished device serial number, you can trace every component consumed, every operator who touched the unit, every equipment tool used, and every test result recorded. In a recall scenario, you can identify the full population of affected devices in minutes and generate the regulatory paperwork in hours. CAPA workflows are integrated directly into the production system — non-conformances trigger corrective action records, and SPC alerts notify engineers before a process drifts out of specification. The entire quality loop closes inside ToolTrack, with no export to a separate QMS required.

Why Chain Reaction Systems?

Legacy MES vendors charge separately for validation documentation packages, 21 CFR Part 11 modules, and every integration you need. Chain Reaction Systems includes all of it at a flat price — unlimited users, all compliance features, all modules. Implementations run 4–8 weeks, not 12–18 months, because ToolTrack is configured, not coded. Our implementation team has hands-on experience with FDA-regulated manufacturing, so we speak your language and understand what your QA team will need to sign off on. Once you're live, our U.S.-based support team handles questions directly — no offshore ticketing queues, no generic answers from people who've never seen a production floor.

How Does Chain Reaction Systems Do This?

We've revolutionized Manufacturing Execution (MES) and shopfloor control software with a unique approach. Unlike many companies that rely on legacy architectures with inflexible database and application layers, our approach prioritizes customization. Conventional products often demand full-time, in-house support and run slow thin client programs that are not compatible with mobile devices and require frequent updates. However, ToolTrack MES distinguishes itself by driving customization through metadata rather than low-level source code adjustments. Additionally, ToolTrack MES features a rapid web-based user interface, allowing access from any device, anywhere.

The adaptable modeling and extensive configuration options in ToolTrack MES enable swift customization of your manufacturing software without the need for expensive programming. Moreover, multiple facilities can maintain autonomy while benefiting from a unified MES solution. Even for customized program logic requirements, implementation is seamless, immediately available to all users without disruption or the need for application re-certification.

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