Press release submitted on behalf of RJG.
RJG, Inc., a global leader in injection molding technology and process control, is proud to announce that its CoPilot® and The Hub® systems have successfully completed full validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This achievement offers critical assurance to manufacturers in regulated and high-risk industries—such as the medical device and automotive sectors—that the systems function as intended and are audit-ready.
CoPilot and The Hub underwent rigorous testing protocols and documentation processes to meet the stringent requirements of quality-focused industries. With this validation in place, customers no longer need to conduct their own time-consuming and costly validation efforts, saving significant resources while accelerating deployment.
“This validation package is a game changer for medical manufacturers,” said Curt Otto, Product Manager at RJG. “It not only saves time during audits and product launches, but also reinforces the reliability and repeatability that’s expected in such high-stakes industries.”
The validated systems now support compliance with FDA 21 CFR Part 11, ISO 13485, IATF 16949, and other regulatory or OEM requirements, making them ideal for a broad range of applications where product quality and process traceability are non-negotiable.
Key Value:
- Save time and money, eliminating the need for internal system validation
- Includes a validation summary with complete IQ/OQ and PQ documentation
- Increase reliability by ensuring the systems perform under validated conditions
- Supports compliance in highly regulated environments
- Enables faster go-live timelines and smoother audits
While particularly suited for medical device and automotive manufacturers, this validation also benefits any organization producing complex or critical plastic components where regulatory alignment and safety are essential.
To learn more about RJG’s validated technology solutions and how they can help your operation meet compliance goals with confidence, visit https://rjginc.com/medical