Independent Modules That You Can Combine to Work Together!
Access Audit Trail
Enter Calibration Events
Document OOT Investigations
Schedule Maintenance Activities
Enter Maintenance Events
Schedule Validation Activities
Enter Validation Events
We offer a suite of SaaS products designed to help managers of FDA regulated companies comply with regulatory requirements including cGMPs, 21CFR11 and other aspects of software qualification. Our software can help you get your equipment management system up and running, on a subscription basis, with minimal up front costs. And, our patented Flash Validation approach to qualification provides the fastest GxP compliance available.
We can have a qualified system ready for your use even BEFORE you have a facility or IT infrastructure.
GxPReady! Suite design:
- Our system is designed for FDA compliance, but can be used by anyone.
- Designed as a SaaS system, using robust and widely used technologies – so it is very stable.
- Designed from scratch as a SaaS system, not a legacy system converted for SaaS use.
- Provides a combination of compliance, performance, reliability, convenience, and efficiency in a very affordable package.
- Not designed as a multi-tenant database, so there is no risk of another customer accessing your data.
- The streamlined design allows flexibility of use without requiring substantial configuration before use.
- Intuitive design means MUCH less time training and reading manuals.
- Our system minimizes the amount of data entry required, so you cut data entry costs and have a smooth, clean workflow.
- Data import and export capabilities.
GxPReady! Suite provides:
- Very fast qualification.
- Easy yet secure internet access. Nothing for you to install.
- No extended contract commitment. Use it as long as it works for you!
- Our facility can be audited and the servers are physically under our control.
- Low cost, reliable access to validated software.
Now you can track your equipment coming into a new facility as it is acquired, even if you don’t have an IT infrastructure!
GxPReady! Suite includes the following:
Equipment Tracking: Track the status and information about equipment.
Calibration Management: Schedule, track, and report calibration activities.
Maintenance Management: Schedule, track, and report equipment and contract maintenance activities.
Validation Management: Schedule, track, and report equipment, method, and process validation activities.
Each of these can be used independently, or the modules can be combined via a single interface to provide a flexible resource for you.
- Virtually unlimited users (no per user license fee).
- A streamlined scheduling software optimized for ease of use and compliance
- Minimal data entry burden and smooth workflows for your department(s)
- Developed for regulated industries by experienced industry professionals
- Focused on compliance within the calibration department with minimal impact on other departments
- 21 CFR Part 11 compliant
- Robust security and reliability
- Qualification of the system included
- Training included
- Built in reporting capability
- Easy multi-site compatibility
- Robust audit trail
- Customer focused change control