Validated CMMS for FDA-Regulated Companies
GxPReady™ helps growing pharma, biotech, and medical device organizations deploy calibration, maintenance, and validation tracking software specifically designed for compliance — without enterprise complexity or long-term contracts.
Compliance Should Support Commercialization,
Not Slow It Down
As companies enter Phase 3 and commercialization, equipment oversight becomes critical. Growing calibration, validation and maintenance departments face a choice between two broken options: general-purpose spreadsheets and complex enterprise systems.
A Validated CMMS Built for FDA- and EMA-Regulated Organizations
GxPReady Suite™ is a validated CMMS designed for regulated companies and delivered as a secure SaaS platform. Using our Flash Validation™ approach, each customer receives a configured, validated environment with an independent database and role-based security controls.
Secure Centralized Equipment Inventory
Your secure dedicated database supports calibration, validation, and maintenance management, with searchable records and asset tracking in one place
Tracking that Supports FDA Compliance
Automated scheduling, reminders, and documentation of calibration, validation, and maintenance activities. Attach supporting documentation for easy access.
21 CFR Part 11 Audit Trail
Complete, secure record of all changes and access — retrieve records and attachments in seconds.
Validation Package Included in Pricing
Qualification using Flash Validation™ gets you validated quickly — without a sandbox environment or heavy configuration testing.
Reduced Data Entry Requirements
Data entry is impact-driven, so users enter only what is needed — saving time, reducing unnecessary work, and helping minimize data entry errors.
Inspection-Ready Records
Retrieve records and attachments quickly — no manual searching of paper files or spreadsheet tabs.
Built for Growing Regulated Companies
Purpose-built for growing regulated companies that have outgrown spreadsheets but don’t need the cost and complexity of an enterprise CMMS.
Pharmaceutical
Production equipment, utilities, calibration, maintenance & qualification
Biotech
Lab, process and GMP equipment from development through commercialization
Medical Device
Manufacturing, inspection and measurement equipment control
Nutraceutical
Practical GMP calibration and preventive maintenance tracking
Compounding Pharmacies
Low cost compliance for calibration and maintenance.
Up and Running in Days, Not Months
Unlike large enterprise platforms, GxPReady uses our patented Flash Validation™ approach. Avoid delays in validation that increase project costs and delay operational readiness.
Rapid Configuration
We confirm your requirements, then configure and deploy your secure, dedicated application.
Validation Package
We provide IQ/OQ validation documentation support as part of a comprehensive turnover package. No waiting on deliverables.
Onboarding & Training
Structured training is included so users are prepared to operate the system.
Qualified & Ready for Use
Configuration, qualification, and turnover documentation are typically completed within days.
Designed to Support Regulatory Expectations
GxPReady has been in use by FDA-regulated organizations for over a decade. The system has supported clients during inspections without reported system-related observations.
Full Audit Trails
Complete, time-stamped audit trails capture creation, access, and record changes, including pre- and post-change information, user identity, username-password authentication, and the reason for each change — all retrievable in seconds during an inspection.
Role-Based Access Control
Restrict system access and permissions based on user roles — no unauthorized modifications to regulated records
Secure Electronic Records
Records protected from unauthorized modification with controlled retention and reliable retrieval
Electronic Signature Support
Attach electronically signed PDF documents from your existing electronic signature system to most types of GxPReady records.
GAMP 5 Risk-Based Validation
Validation approach aligned with GAMP 5 principles to reduce scope and speed up qualification
21 CFR Part 11
Designed for FDA electronic records & audit trail requirements
FDA Electronic RecordsEMA Annex 11
Supports EU GMP computerised system expectations
EMA EU GMP10+ Years
In active use by FDA-regulated organizations
Inspection ReadyEase of Use
Enter key results only—attach supporting records as needed.
Save Time/EffortStart Free. Stay Month-to-Month.
Evaluate GxPReady before committing. Serious prospects can move into a customized 60-day trial, then continue month-to-month with simple pricing and no long-term contract.
- Customized environment
- Full platform access
- Setup can carry forward if you proceed
- No subscription commitment
- Independent customer database
- $45/month per billable user
- Pricing capped after 10 users
- Cancel anytime — no penalty
- Validation and qualification package
- Flash Validation™ approach
- Builds on work already completed
- Fixed one-time validation fee
Optional Services When You Need Them
Need additional help? We work with you directly and provide à la carte support when it makes sense.
Built by Compliance Professionals,
for Compliance Professionals
GxPReady was created by engineers and validation professionals who experienced firsthand the burden of complex enterprise systems in regulated environments.
Founder"GxPReady was built to deliver validated CMMS that supports compliance without slowing innovation or burdening operations."
Vince founded GxPReady after experiencing firsthand the gap between what growing regulated companies need and what enterprise systems deliver. His background in engineering and validation led to the development of a practical, fast-to-deploy platform that serves pharma, biotech, and medical device organizations without unnecessary complexity or long-term commitments.
VP SalesDan brings over 30 years of experience in calibration, metrology, automation, and GxP compliance to his role as Vice President of Sales at GxPReady. With a deep background in biotech, pharmaceuticals, and regulated systems, Dan works with life sciences companies to identify practical compliance solutions for calibration, maintenance, automation, and validation programs. His hands-on expertise spans automation system design, commissioning and qualification, and calibration program development.
Trusted by Regulated Industry Professionals
Frequently Asked Questions
Implement Validated CMMS in Days, Not Months
GxPReady helps growing FDA-regulated companies deploy validated calibration, maintenance, and validation tracking software quickly — without enterprise complexity or long-term commitments.