Nanox, a medical imaging innovator aiming for greater diagnostic accessibility, initially used Dot Compliance’s eQMS but experienced churn. Under QA Director Dorit Nahari, Nanox strategically reimplemented Dot Compliance, achieving a rapid 6-week implementation, including data migration, and successfully passed an ISO 13485 audit just three days after go-live.
THE CHALLENGE
Rebuilding Trust: Returning as a former customer presented the initial hurdle of reestablishing trust. Nanox needed to be convinced of Dot Compliance’s renewed value and reliability.
Rapid Implementation Timeline: The request for a 6-week implementation, encompassing data migration, posed a significant challenge. The impending ISO 13485 audit amplified the pressure.
Data Migration Complexity: Migrating 700 critical documents required meticulous attention to detail, ensuring accuracy and integrity.
Initial Resistance to Change: As with any change, there was some initial resistance to the reimplementation, which created a change management challenge.
Audit Readiness: Achieving audit readiness within three days of go-live demanded exceptional efficiency and thorough preparation.
THE SOLUTION
Phased Implementation: The project was executed in a focused Phase 1, covering Document Management, Training Management, and Data Migration, allowing for targeted execution.
Intensive Collaboration: Onsite meetings and extended workshops facilitated close collaboration. QA Specialist, Tiki Elisha’s active participation and rapid learning were instrumental in mastering the
Dot Compliance system.
Dedicated Audit Preparation: A collaborative review of the audit agenda, creation of a dedicated audit binder, a preparation meeting with Dot Compliance’s director of quality assurance and compliance, and on-call support during the audit ensured thorough preparedness.
Data Migration Execution: A carefully planned and executed process ensured the smooth transfer of all 700 documents.
Change Management: Through demonstrations, showcasing the platform’s efficiency, and strong team support, the head of the company overcame resistance.
BENEFITS
Successful ISO 13485 Audit: Nanox successfully passed the ISO 13485 audit just three days after go-live, a testament to the effectiveness of the Dot Compliance implementation.
Increased Efficiency and Compliance: Streamlined document and training management processes significantly improved efficiency and compliance, saving critical time for Nanox. The transition to a paperless system further enhanced operational agility.
Improved User Adoption: The demand for users surged within Nanox, reflecting high user satisfaction and adoption. Elisha’s mastery of the system demonstrated the platform’s user friendliness.
Superior Support and Speed: Support tickets were always resolved quickly and efficiently. Nanox consistently praised Dot Compliance’s superior support and rapid implementation, contrasting favorably with competitors.
Change Management Success: The team successfully navigated internal resistance, leading to widespread adoption and appreciation for the Dot Compliance system.
Change Management Success: The team successfully navigated internal resistance, leading to widespread adoption and appreciation for the Dot Compliance system.
A STRATEGIC COLLABORATION THAT DELIVERED
Nanox’s successful Dot Compliance reimplementation highlights strong partnership and efficient execution, leading to audit success and improved quality management. Effective change management and high user adoption further validate Dot Compliance’s value in achieving rapid, organization-wide quality and compliance.
