TracePointMES is a modern, lightweight MES built for pharmaceutical GMP manufacturing. Recipe management, electronic batch records, electronic signatures, and immutable audit trail — at a fraction of the cost and complexity of legacy enterprise systems.
PostgreSQL · Node.js · React · Self-hosted or cloud · No per-seat licensing
Built for the realities of GMP manufacturing floors — where simplicity, reliability, and compliance aren't optional.
Kerner AMT ESR-compliant e-signatures integrated directly into batch record workflows. Password re-authentication per signature per 21 CFR Part 11.
SHA-256 hash-chained audit records. Every create, modify, approve, and reject is permanent. Chain integrity is verified on every view.
Replace paper batch records with structured, version-controlled electronic records. Operator sign-off, verifier approval, and full traceability per step.
When a value falls outside the defined specification, operators must provide a mandatory justification comment to proceed. Stored and auditable.
Same-rank peer approval enforced. A supervisor cannot approve work at their own rank level — preventing rank inflation and ensuring genuine independent review.
Define event types per equipment class with custom parameter fields. Forms adapt to the equipment type — no more generic catch-all event entry screens.
Draft, submit for approval, approve or reject — versioned recipes lock at batch creation time. Every change is tracked, reviewed, and traceable.
Multi-path recipes based on live variable values. Define conditions like "if pH > 7.0 → jump to step #3". Operators follow the correct path automatically.
Compose batch record steps exactly as operators will see them. Live preview shows field layouts, variable placeholders, range indicators, and branching logic.
Full equipment registry with class definitions, location tracking, and status management. Retire equipment without losing historical event data.
Live dashboard showing equipment status, active events, pending approvals, and recent activity. Floor supervisors get the picture at a glance.
Search across events, batch records, and audit entries. Filter by equipment, date range, operator, status, and more. Export results to CSV.
Toggle permissions per role on a clear grid. Operator, supervisor, and admin access laid out as a matrix — see at a glance who can do what.
Full operator interface works on tablets and mobile devices on the shop floor. Responsive layout adapts to any screen size.
7-year record retention enforced. No data loss on updates. Database backups treated as electronic records — included in your retention policy.
TracePointMES delivers the core capabilities you actually need — without the complexity, cost, and multi-year implementations.
| Capability | TracePointMES This Product | Wonderware Syncade | Honeywell POMS+ | Siemens OpCenter |
|---|---|---|---|---|
| Electronic Batch Records | ✓ | ✓ | ✓ | ✓ |
| 21 CFR Part 11 E-Signatures | ✓ | ✓ | ✓ | ✓ |
| Immutable Audit Trail (hash-chained) | ✓ | partial | partial | partial |
| Recipe Version Control | ✓ | ✓ | ✓ | ✓ |
| Multi-path Conditional Branching | ✓ | partial | partial | partial |
| WYSIWYG Recipe Editor | ✓ | – | – | – |
| Out-of-Range Justification Enforcement | ✓ | – | – | – |
| Rank-Based Approval (same-rank peer) | ✓ | – | – | – |
| Visual RBAC Matrix | ✓ | – | – | – |
| Equipment-Class Scoped Event Forms | ✓ | ✓ | ✓ | ✓ |
| CSV Import / Export | ✓ | ✓ | ✓ | ✓ |
| Audit Chain Integrity Verification | ✓ | – | – | – |
| Self-Hosted (no cloud required) | ✓ | partial | partial | ✓ |
| Setup time | < 1 day | Weeks–months | Weeks–months | Weeks–months |
| Per-seat licensing | No | Yes | Yes | Yes |
No proprietary lock-in. Standard tools that your team can understand, extend, and maintain.
Every screen is purpose-built for GMP manufacturing — not adapted from a generic ERP.
Get a live demo on your own hardware. No sales pitch — just the system running in your environment.
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