When you make components that wind up in—or on—the human body, the manufacturing line becomes a regulated environment in its own right. Every sensor reading, alarm, and keystroke must be:

• Documented
• Verified
• Ready for a surprise audit 

That is why process‐control software typically spends months (and tens of thousands of dollars) bogged down in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) before it can ever collect a byte of production data.

RJG just rewrote that playbook. The CoPilot® and The Hub®—already familiar names in scientific molding— now include RJG’s full internal validation summary report.

For medical molders, that single milestone erases an entire layer of risk, cost, and schedule pressure.

—already familiar names in scientific molding—include a completed full internal validation summary report.

The Compliance Headaches Medical Molders Face Every Day  

• Validation fatigue. New software can often trigger weeks of protocol writing, dry‐runs, and signature collection.We minimize this by doing some of the work for you.
• Audit anxiety. FDA 21 CFR Part 11 demands strict user controls, electronic signatures, and audit trails—requirements many legacy systems can’t natively support. We validate our software according to FDA guidelines.
• Traceability gaps. A single missed data point can derail a device history record (DHR) and delay product release. We help lower that risk through extensive testing up front.
• Rising cost of quality. Manual data collection and rework inflate cost per part and delay time to market. We address this by automating data capture, increasing process visibility, and reducing reliance on manual inspection.

How a Fully Validated CoPilot + Hub Stack Solves Those Pain Points  

Typical Challenge	How the Validated Stack Responds
Time to test new software	Streamline it. We’ve streamlined the process by shipping you software that’s already been tested and validated.
Prove Part 11 readiness	Audit-ready from Day 1. Role-based access, secure e-records, and immutable audit logs are baked in.
Keep data in silos	Visible, automated DHR population. Mold-side data stream into The Hub for enterprise-wide visibility in a central location.
Contain defects fast	Real-time alarms. CoPilot uses cavity pressure to stop shorts, burns, or flash before they leave the press.
Justify the ROI	Validation cost savings. Eliminate a large portion of internal protocol drafting, resource allocation, and consultant hours—often a five-figure line item per asset.

The Business Impact in Numbers  

• Go to market faster by eliminating time on internal system validation.
• Labor reduction in IQ/OQ/PQ documentation hours, based on typical medical‐device manufacturer benchmarks.
• Scrap reduction when real-time cavity-pressure monitoring replaces post-mold inspection.

Beyond Compliance: A Platform for Continuous Improvement  

Once validated, the same architecture unlocks smart-factory capabilities:

• Predictive analytics—feed Hub data to your MES or ERP for proactive maintenance and material lot traceability.
• Global process transfer—validated methods replicate across sites without re-writing protocols, critical for multi-plant medical programs.
• Scalable innovation—RJG commit’s to continue releasing validated updates for Copilot and Hub functionality for the medical industry.

Ready to Ditch the Paper Chase?
If you’re tired of treating compliance as a hurdle instead of a competitive advantage, RJG’s validated CoPilot and Hub combination is your shortest path to production. You’ll spend less time writing protocols—and more time making flawless parts. rjginc.com/medical