🎛️ Helm™ · Operations & Maintenance
Equipment. Maintenance. Calibration. Under Control.
Maintenance Requests, calibration schedules, and equipment records - with IQ/OQ tracking and two-person post-repair sign-off. Helm™ keeps your facility audit-ready and your equipment running.
Maintenance Request Lifecycle
From equipment failure to verified repair - tracked every step
Helm™ follows a structured maintenance workflow with sequential numbering and every required sign-off captured at the right stage.
1
MR Created
Equipment issue logged with description, priority, and equipment ID
2
Assigned
Assigned to maintenance tech with target completion date
3
In Progress
Work started, temporary repair flag if applicable
4
Post-Repair Clean
Post-repair cleaning completed and signed off by tech
5
IQ/OQ Verified
Installation/operational qualification verified if required
6
Closed
Repair verified, equipment returned to production status
Helm™ Features
Every operations tool in one module
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Maintenance Requests (MR-XXXXX)
Create and track maintenance requests with sequential numbering, priority classification, temporary repair flag, installation/operational qualification requirement flag, and post-repair cleaning sign-off.
6-Stage Workflow
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Corrective & Preventive Maintenance
Track both corrective (breakdown response) and preventive (scheduled) maintenance. Preventive schedules generate MRs automatically at configured intervals - so nothing falls through the cracks.
CMMS-Ready
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Calibration Records
Calibration records for all measurement equipment - scales, thermometers, gauges, metal detectors. Calibration date, next due date, performed by, and certificate attachment. Overdue calibrations surface on the Lighthouse™ dashboard.
21 CFR Compliant
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Equipment Registry
Central registry of all equipment with asset ID, manufacturer, model, serial number, location, and status. Linked to maintenance history and calibration records - one record, full equipment lifecycle.
Asset Management
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Post-Repair Cleaning Sign-Off
Helm™ enforces that post-repair cleaning is completed and signed by a qualified team member before equipment returns to production - meeting GMP requirements for food contact surfaces.
GMP Required
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Environmental Monitoring
Temperature and humidity logs for cold storage, processing areas, and warehousing. Configurable alert thresholds. Ties directly into QA's environmental monitoring program.
FSMA 204 Signal
Stop managing maintenance in spreadsheets
Helm™ gives your operations team a digital maintenance system that satisfies your QA manager and your FDA auditor - without IT overhead.