Proven Track Record
Used successfully by regulated manufacturers for over a decade.
Validated CMMS
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.
Designed for:
21 CFR Part 11 EMA Annex 11 GMP GAMP 5
Independent database per customer
Validation documentation included at deployment
Inspection-ready records in seconds
Cancel anytime — no penalty
The Problem
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.
"Spreadsheets struggle with role based security, ease of use, and audit trails while heavyweight enterprise systems have cost, configuration, and complexity challenges. Either can create compliance risk for growing regulated companies."
What Is GxPReady?
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.
GxPReady Suite™ Validated CMMS
Platform Highlights
Why Companies Choose GxPReady
GxPReady Suite™ Features a core platform and includes calibration, validation, and maintenance modules. These are designed to reduce burden on quality, validation and operations while keeping records inspection-ready.
21 CFR Part 11 Audit Trail
Traceable, time stamped, attributable, retrievable records of activities and record changes support inspection readiness.
Minimal Configuration
Sensible design minimizes the need for complex configuration and change control overhead.
Fast Qualification
Comprehensive Turnover Package (TOP) supports rapid qualification with minimal post-deployment testing
Personal Support
Work directly with experienced GMP professionals who take the time to understand your questions and provide practical assistance.
Low Cost/Risk of Ownership
Efficient deployment, straightforward administration, and validation included. No long-term commitments.
Who It's For
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.
Flash Validation™ Deployment
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.
1
Rapid Configuration
We confirm your requirements, then configure and deploy your secure, dedicated application.
2
Validation Package
We provide IQ/OQ validation documentation support as part of a comprehensive turnover package. No waiting on deliverables.
3
Onboarding & Training
Structured training is included so users are prepared to operate the system.
4
Qualified & Ready for Use
Configuration, qualification, and turnover documentation are typically completed within days.
21 CFR Part 11 & GxP Compliance
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/EffortTransparent Pricing
Start 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 Trial
60 Days / free
Evaluate GxPReady in a configured environment before deciding whether to move forward.
- Customized environment
- Full platform access
- Setup can carry forward if you proceed
- No subscription commitment
Simple Monthly Pricing
Monthly Subscription
$45 / user / month
Standard subscription pricing is capped after 10 billable users — up to $450 per month.
- Independent customer database
- $45/month per billable user
- Pricing capped after 10 users
- Cancel anytime — no penalty
Validation Package
$995 / one-time
When you're ready to proceed, a fixed one-time fee starts the formal qualification process.
- 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.
Data Entry & Transfer Help entering, organizing, or transferring existing equipment and maintenance data.
Gap Assessments Practical review and assistance identifying gaps in your existing program.
Electronic Data Forms Electronically completable forms developed for your specific workflow or records.
Database Backup Delivery Optional delivery of database backups on a recurring basis.
Special Requests If you need something outside the standard platform, talk with us and we'll see what makes sense.
Our Team
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.
FounderVince Sebald
Founder & CEO, GxPReady
"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 Cooper
Vice President of Sales, GxPReady
Dan 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.
What Customers Are Saying About GxPReady
Trusted by Regulated Industry Professionals
Common Questions
Frequently Asked Questions
What is validated CMMS software?
Validated CMMS software is a maintenance management system designed to support regulatory requirements in FDA- and EMA-regulated environments. It includes audit trails, controlled user access, and validation documentation to help maintain compliant electronic records.
Read full article Does CMMS need to support 21 CFR Part 11?
If the system stores electronic records used for regulated activities, it should support 21 CFR Part 11 requirements such as audit trails, user authentication, and record integrity controls.
Read full article How long does it take to deploy GxPReady?
Most organizations can be configured, trained, and qualified within days — significantly faster than enterprise deployments of 3–6 months, depending on internal documentation readiness.
Read full article Is GxPReady suitable for Phase 3 companies?
Yes. GxPReady is built for growing regulated companies transitioning into Phase 3 and commercialization that need compliant calibration and maintenance tracking without enterprise overhead.
Read full article Do customers share databases?
No. Each customer operates within an independent database environment with no shared multi-tenant record access. Your data and records remain completely isolated from other customers.
Read full article Is a free trial available?
Yes. Interested customers can evaluate a configured GxPReady environment for up to 60 days at no cost before deciding whether to proceed.
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.