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?

ToolTrack's metadata-driven architecture means your process engineers configure work instructions, routing steps, and data collection fields through the UI — not a development team writing code. For medical device manufacturers, this changes how you manage your MES validation. You qualify the application once. After that, process changes go through ToolTrack's built-in change management workflow, which generates the documented approval trail your quality team needs — without re-certifying the underlying platform every time a routing changes.

Electronic signatures, audit logs, and 21 CFR Part 11 controls are native to the system, not add-on modules. DHR records, non-conformance workflows, and CAPA linkages are configured to your procedures through the UI and deployed immediately to all users with no downtime. The platform runs as a web application — no client software to validate, no deployment windows to coordinate, no version mismatch between sites. Your entire team — operators, QA, engineers — works from the same instance with role-appropriate access, on any device.

ToolTrack MES Benefits

Pull a complete DHR for any serial number in seconds — not a multi-day records retrieval exercise before an FDA audit.
21 CFR Part 11 electronic signatures enforced at configurable steps — no paper backup, no workarounds.
CAPA workflows close inside ToolTrack — non-conformances trigger corrective action records without exporting to a separate QMS.
Recall response in minutes — identify the full population of affected devices and the components they share from a single query.
Process changes don't require MES re-validation — change management workflow generates the documentation trail, not a new implementation project.
Faster NPI with routing and data collection configured in the UI the same day — no development cycle between product design and production readiness.

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