THE SOLUTION
Why cGMPnow?
The Problem
The standard industry GxP Systems delivery methodology for GxP MFG facilities is faced with the following issues:
- The A&E/GC focus on the facility Design/Build with no focus on GxP systems
- GxP Readiness is pushed to the Owner who typically does not have the bandwidth to handle it on top of day-to-day operations
- The GxP MFG/Lab equipment, Computerized Systems, & CQV/GxP-documentation efforts are silo’d and disconnected
- A&E/GC facility handover does not include adequate CQV or GxP documentation
- Owner procurement systems cannot handle the quantity of GxP MFG and Laboratory Equipment that needs to be purchased associated with the project
- GxP Systems are an afterthought and up-front facility designs do not adequately account for their needs
- Facility Designs by the A&E do not keep pace with rapidly changing GxP regulatory requirements
The Solution
cGMPnow effectively delivers the GxP Systems for our clients to begin production, without time delays, design shortcomings and the typical project set-backs. What does this mean to your team? We help accelerate life-changing products to patients.