Full Lot Traceability. Automated Audit Trails. Zero Compliance Gaps.
In regulated manufacturing and dental labs, traceability isn't a feature - it's a legal requirement. But maintaining it manually across paper records and disconnected systems creates exactly the gaps that fail inspections. ZeyOS builds traceability into every production step automatically.
Serial & Lot Tracking from Intake to Delivery
Track every material lot and finished item with full chain-of-custody records. Complete traceability without manual documentation.
Audit Trails Built Into Every Workflow
Every action - who did what, when, and on which item - is automatically logged. Inspection-ready records without the paperwork burden.
API Integration with Lab & ERP Systems
Connect ZeyOS to lab information systems, quality management software, or existing ERP via REST API. No manual data bridges.
Track Every Item from Raw Material to Patient Delivery
In dental labs and medical device manufacturing, a traceability gap isn't an administrative inconvenience - it can trigger a recall or fail a regulatory audit. ZeyOS creates an unbroken digital chain from material receipt through production and final delivery, with every step timestamped and attributed to the responsible operator.
Lot & Serial Number Management Assign lot numbers to incoming materials at goods receipt. Every production step consumes from tracked lots - no manual reconciliation.
Chain-of-Custody Records Every handoff between workstations or departments creates an automatic record. Who handled the item, when, and what was done - permanently logged.
Expiration Date Management Track expiry dates on materials and consumables. Automatic alerts before expiry, and FEFO (first expired, first out) picking enforced at consumption.
Reverse Traceability Given a finished item or delivery, instantly trace every material lot and production step that contributed to it. Essential for complaint handling and recalls.
Production Workflows with Built-In Quality Gates
Quality control shouldn't be a final inspection that catches problems too late. ZeyOS lets you define mandatory quality checkpoints at each production stage - so items cannot advance without passing the required verification. Quality becomes a workflow property, not a separate department.
Stage-Gate Workflows Define production stages with mandatory completion criteria. No item advances to the next stage until the current stage is formally closed and signed off.
Digital Operator Sign-Off Each production step requires operator identification and confirmation. Automatically captured in the item's production record without paper forms.
Work Order Management Create and track work orders for each job or production run. Connect orders to customer records, prescriptions, and delivery commitments.
Non-Conformance Tracking Log and investigate non-conformances directly in the production record. Root cause analysis and corrective actions documented in the same system.
Inspection-Ready Records Without the Manual Burden
Preparing for an ISO 13485 audit or dental lab inspection shouldn't mean weeks of manual record compilation. ZeyOS maintains continuously updated compliance records as a natural by-product of normal operations - so when the auditor arrives, your documentation is already complete.
Automated Audit Logs Every user action that touches a regulated record is automatically logged with timestamp, user identity, and the change made. No manual record-keeping required.
Document Control Maintain version-controlled SOPs and work instructions within ZeyOS . Operators always see the current approved version - and acknowledgment is automatically recorded.
Regulatory Reporting Generate traceability reports, lot history reports, and non-conformance summaries on demand. Export in formats suitable for regulatory submission.
Role-Based Access Define exactly who can view, modify, or sign off each type of record. Separation of duties enforced at the system level, not by procedure alone.
Dental Manufacturing Lab, 45 Staff
Our last inspection took two days because we had to compile records manually from production logs, spreadsheets, and paper forms. Since moving to ZeyOS, our traceability records are generated automatically as we work. Our most recent audit took half a day - the inspector was satisfied before lunch.
Build Compliance Into Your Operations, Not Onto Them
Book a session to see how ZeyOS handles your specific compliance requirements - lot tracking, audit trails, document control, and reporting configured for your regulatory environment.
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