Vince Sebald, BSEE
Vince started his career as a control systems engineer and has worked at various small to large pharmaceutical companies at the director level including areas such as calibration, engineering, and operations during the past 25+ years. Currently he consults for FDA regulated companies in the areas of engineering and validation including computer system validation. Vince and the rest of the team have worked to develop GxPReady! Suite as an alternative to the resource intensive options currently available for calibration, maintenance and validation tracking. This provides an option for life-science companies to focus more of their attention on the core competency of developing and bringing to market their innovative products.
GxPReady! is comprised of professionals with decades of experience in life-science related industries (e.g. pharmaceutical, medical device, biotech).
Our goal is to provide software you need for Calibration Scheduling, Maintenance Scheduling, and Validation Scheduling for your GxP compliant facility that you can access on line. This saves your company time, money and effort.
We have been through the challenges of the old-school installation of software solutions. We founded GxPReady! and invented Flash Validation to bring a revolutionary approach that dramatically reduces up front time and financial investment to have a qualified system ready to work for you.
There is a better way to put qualified software to use for your company. You can achieve qualification earlier in your company life cycle while saving money, time, and with more control over the process.
We offer software developed specifically for regulated industries and the documentation you need to get right to using it.
- Calibration, Validation, and Maintenance management
- Developed from the ground up to meet US and EU regulatory requirements including 21CFR11
- Advanced development techniques and ISO 9001 development resources to ensure quality by design
- Auditable, documented quality systems
- Robust security
- Comprehensive audit trail
- Designed for ease of use and ease of implementation
Getting qualified software is now easier than ever!