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Maintenance Management Software for FDA-Regulated Companies

Track Equipment Maintenance with Inspection-Ready Records

GxPReady® provides maintenance management software for pharmaceutical, biotech, medical device, and nutraceutical companies operating in FDA- and EMA-regulated environments.

Schedule preventive maintenance, document completed work, and quickly retrieve traceable equipment maintenance records—without enterprise system complexity.

Equipment maintenance management

Maintain Inspection-Ready
Maintenance Records

Maintenance documentation helps demonstrate that equipment is properly maintained and remains suitable for use. Missing, incomplete, or difficult-to-access maintenance records can create inspection risk and operational delays.

This module keeps equipment maintenance records organized, traceable, and inspection-ready.

GxPReady helps keep you organized:

  • Track preventive maintenance schedules and due dates and corrective maintenance.
  • Manage multiple recurring maintenance schedules for each equipment item
  • Document completed work and maintain a complete maintenance history
  • Store maintenance procedures and supporting documentation
  • Maintain secure audit trails for maintenance record changes

Core Maintenance Module Features

GxPReady provides maintenance management functionality designed to help regulated companies schedule, document, and maintain traceable equipment maintenance records. The system includes:

Preventive maintenance schedule tracking, corrective maintenance documentations, and due date management

Multiple recurring maintenance schedules for each equipment item

Secure audit trails for maintenance record creation and modification

Controlled assignment, completion, review, and approval of maintenance work

Attachment support for procedures, work records, and supporting documentation

Complete maintenance history linked to each equipment record

Equipment validation in pharmaceutical and biotech manufacturing

Built for Pharmaceutical, Biotech, and Medical Device Companies

GxPReady is designed for regulated organizations that must maintain traceable equipment preventive and corrective maintenance records under FDA and EMA requirements.

Ideal for companies that need to:

  • Maintain controlled equipment preventive and corrective maintenance records
  • Support inspection-ready protocols, approvals, and reports
  • Track recurring preventive maintenance and corrective maintenance activities and due dates

Designed to reduce administrative effort while maintaining traceable maintenance schedules, documentation, approvals, and equipment history.

Designed to Support 21 CFR Part 11 and GMP Requirements

Electronic maintenance records must support regulatory expectations for record integrity, traceability, and inspection readiness.

GxPReady supports compliance

Learn more about 21 CFR Part 11 compliance software
Secure audit trails for maintenance record changes
Role-based system access controls
Secure maintenance record storage and retrieval
Validation documentation supporting system qualification

What Is Maintenance Management Software?

Maintenance management software helps regulated organizations schedule, manage, and document preventive and corrective equipment maintenance activities.

GxPReady maintenance event record for preventive and corrective maintenance scheduling, change control tracking, and file attachments

For FDA-regulated companies, maintenance management software helps ensure:

  • Preventive maintenance is performed according to required schedules
  • Corrective maintenance activities are documented and traceable
  • Maintenance records are securely stored and accessible
  • Complete equipment histories are available during inspections

The GxPReady maintenance module provides preventive and corrective maintenance management software designed specifically for regulated life science environments.

See Maintenance Management in Practice

Reviewing maintenance tracking workflows in a live environment helps teams evaluate inspection readiness and documentation traceability before implementation.

A live demo allows you to see how GxPReady supports maintenance tracking, audit trails, and inspection readiness while reducing compliance workload and operational complexity.