GMP Equipment Management for 21 CFR Part 11
GxPReady Suite is an integrated GMP equipment management platform that maintains a centralized equipment inventory while tracking maintenance, calibration, qualification, and validation records.
Designed for regulated life science environments, GxPReady Suite includes configurable security and access controls, electronic record management, scheduling, specialized reporting, audit trails, and authenticated user actions that support compliance with 21 CFR Part 11 and EU Annex 11.
Manage the GMP equipment lifecycle in one system
GxPReady Suite connects equipment records with the activities required to keep each asset maintained, calibrated, qualified, and ready for use.
- Centralized equipment inventory and history
- Preventive and corrective maintenance tracking
- Calibration scheduling, execution, and approvals
- Validation and qualification activity tracking
- Traceable records linked to each equipment item
Designed for regulated electronic records
Electronic systems used to manage GMP equipment records should provide appropriate controls for access, traceability, record integrity, authenticated actions, retention, and retrieval.
Unique user authentication and role-based permissions.
Critical record activity is documented and traceable.
Users authenticate applicable record changes and review activities.
Changes require documentation of the reason for the modification.
Controls help protect against unauthorized record changes.
Electronic records remain available for review and inspection.
Electronic signatures and authenticated record changes
When applicable GxPReady records are created or changed, the user reviews the information and re-enters unique credentials before the record is saved. The associated activity is documented in the audit trail, including the user, date and time, and reason for the change.
Review or approval activity may also be documented within a GxPReady record. When that record is saved, the user is required to authenticate the action using their credentials.
Externally signed documents are also supported.
GxPReady can retain electronically signed documents, including signed PDFs, as attachments to the applicable equipment, calibration, maintenance, qualification, or validation record. Fillable PDF forms and procedures generated outside GxPReady may also be completed and retained with the associated record.
Practical compliance without enterprise complexity
GxPReady Suite provides the core functionality regulated manufacturers and laboratories need without the cost, implementation burden, and administrative overhead commonly associated with large enterprise systems.
- Designed specifically for regulated life science environments
- Straightforward setup and configuration
- Low ongoing administrative workload
- Validation documentation included
- Affordable for small and mid-sized regulated organizations
Validation support included
GxPReady Suite is supplied with supporting validation documentation, including IQ/OQ materials, to simplify implementation. Each regulated organization remains responsible for validating the system for its intended use and maintaining compliance through its own procedures and quality system. Additional information on GxPReady’s validation approach, quality system, security, and supplier qualification support is available in our Quality & Trust Center.
Who GxPReady Suite is designed for
GxPReady Suite is intended for regulated organizations that need reliable, inspection-ready equipment records without the operational burden of a traditional enterprise CMMS.
See GxPReady Suite in action
Schedule a live demonstration or request a free trial to see how GxPReady Suite can support equipment management, calibration, maintenance, qualification, and validation activities.