Frequently Asked Questions

A validated CMMS (Computerized Maintenance Management System) is software qualified for use in regulated environments where electronic records must meet GMP and FDA requirements.

A validated CMMS should:

• Maintain secure audit trails
• Control user access
• Protect electronic records
• Support inspection readiness
• Include validation documentation

Yes. GxPReady is designed specifically for small to mid-sized regulated companies (10–200 employees) transitioning into Phase 3 and commercial manufacturing.

It is ideal for organizations that need:

• Rapid deployment
• Inspection-ready documentation
• Reduced validation burden
• No enterprise-level complexity

Most organizations can configure, train, and qualify GxPReady within days.

Because configuration options are controlled and validation documentation (IQ/OQ support) is included, qualification effort is significantly reduced compared to highly customized enterprise systems.

GxPReady is designed for growing regulated companies that need compliance without enterprise complexity.

Unlike highly configurable enterprise platforms, GxPReady:

• Deploys in days instead of months
• Includes validation documentation
• Requires minimal configuration
• Does not require long-term contracts

It is built to support inspection readiness without a heavy administrative burden.

Yes. GxPReady is designed to support electronic record expectations under:

• 21 CFR Part 11
• EU Annex 11
• GMP-regulated environments

The system includes role-based access controls, secure audit trails, electronic record protection, and validation documentation. Final compliance remains the responsibility of the regulated organization.

If the system stores electronic records used to demonstrate GMP compliance, it should support 21 CFR Part 11 expectations such as audit trails, user authentication, and record integrity controls.

General maintenance tools often lack these protections.

Compliance depends on how the system is implemented, validated, and used within your quality system.

GxPReady is designed to support regulatory expectations, but validation and ongoing compliance remain the responsibility of the regulated organization.

No regulation explicitly prohibits spreadsheets. However, spreadsheets typically lack secure access controls, automated audit trails, and controlled change tracking.

As organizations grow, spreadsheet-based systems become difficult to validate and maintain in regulated environments.

GxPReady includes:

• Equipment registry management
• Calibration tracking
• Preventive maintenance tracking
• Validation tracking (IQ/OQ documentation)
• Secure audit trails
• Document attachment support
• Automated due-date notifications
• Exportable reports

All modules operate within one validated platform.

GxPReady is intentionally not pre-configured for complex integrations.

Integrations can increase validation scope and introduce compliance risks. The platform is designed to maintain data integrity and enable rapid qualification without dependency on external systems.

GxPReady is cloud-based and operates within a secure, qualified environment that includes controlled access, automated backups, and geographically diverse redundancy.

Yes. Structured equipment numbering improves traceability, documentation control, and inspection readiness.

Consistent identification reduces compliance risk during audits.

Pricing includes:

• One-time validated setup fee
• Monthly subscription pricing
• Included validation documentation
• Product training
• Platform updates

There are no long-term contracts.

No. GxPReady uses flexible subscription pricing.

• No multi-year commitments
• Cancel anytime
• Predictable monthly pricing

Customer Data remains the customer's property. Under GxPReady's standard customer agreement, customers are provided with a Customer Data Export Package upon termination or expiration.

The package is designed to preserve the database structure, relationships, attachments, and associated electronic information maintained by the system, which may include audit-trail information, electronic-signature information, review and approval information, record status information, and metadata.

The export is provided using a secure electronic transfer method. Human-readable records and reports may also be provided where reasonably practicable.

Under the standard agreement, Customer Data remains available for retrieval for 90 calendar days following termination or expiration. Extended retention, additional exports, data conversion, migration assistance, or other transition services may be available and may involve additional fees.

Specific rights, obligations, retention periods, services, and fees are governed by the applicable customer agreement, which controls in the event of any inconsistency with information on this website.

Training is included during deployment.

Audit assistance is available if needed, though the provided validation documentation package is typically sufficient to support inspection readiness.