Maintain biotech and pharma project progress with clean transitions from engineering to validation
It's of little value to push forward for months just to be held back at the next checkpoint. Yet that's what happens in many pharmaceutical and biotechnology control engineering projects. The controls team doesn't fully appreciate what's required for validation or the validation team lacks in-depth knowledge of controls.
Instead of a smooth handoff, you lose time and money covering the same ground twice. You also risk becoming immersed in fingerpointing and fumbles you'd greatly prefer to avoid.
We can help, even if you engage us only for controls engineering or for control system validation. Why? Because we do both, we understand just how, where and when one hand must meet the other.
Validatable control systems
Because we perform control system validation, RoviSys staff knows how to engineer, implement and document validatable control systems.
RoviSys engineers and developers who work in pharmaceutical controls engineering must pass our internal GAMP training. Overall project direction is provided by experienced pharmaceutical and biotechnology automation project leaders.
The result are advanced control systems streamlined for validation. The process is aided by our proven project management, collaboration and document tracking system, GrandView.
- Functional definition
- Validatable control system design
- Validation documentation
- Implementation and integration
- Batch integration and electronic records
- Project plan, management & collaboration
- Clean transitions from
control system engineering
- Commissioning
- CSV and qualification documentation
- CSV and qualification execution
- Document tracking
Discover how clean transitions can work for you
Build in clean hand-overs, avoid disruptive drop-offs and get your projects done. That's part of the proven services we provide to the world's leading pharmaceutical and biotechnolgy companies. For more information on RoviSys biopharm controls engineering and control system validation, follow the links at left. Or contact John Turk, director of Pharmaceutical Controls Engineering and Control System Validation Services, at 330-562-8600 or john_turk@rovisys.com.