A Rapid Return to Quality & Compliance with Dot Compliance

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.

Satsuma Pharmaceuticals Accelerates Quality Management with Dot Compliance

THE CHALLENGE

Satsuma Pharmaceuticals (Satsuma) is a pharmaceutical innovator that is committed to providing novel treatments to those who suffer from migraine and other debilitating conditions.

Satsuma needed to transition from clinical trials to a commercial operation, but its previous electronic quality management system (eQMS) was not robust enough to effectively enable this transition.

Satsuma realized that it would need an eQMS with processes that align with Good Manufacturing Practices (GMP) and would provide automated vendor management, document control, and training effectiveness tracking.

THE SOLUTION

In its quest for a solution, Satsuma turned to Dot Compliance. The software’s out-of-the-box usability and the vendor module for maintaining vendor qualifications were key factors.

Janera Harris, Senior Director of QA & Compliance at Satsuma said, “The free trial allowed our users to access the system and use the different modules. We met with Dot Compliance weekly to answer any questions that arose. This allowed our users to see if the system met their requirements.”

In terms of usability, Harris said, “We did not need to customize the product and Dot Compliance was usable for us right out of the box. In addition, the projected amount of time from setup to launch aligned with our timeline.”

BENEFITS

The Dot Compliance eQMS significantly improved document revisions, change control, and quality event processes and made it easier to capture data and track signatures, leading to greater efficiency and cost savings. The solution seamlessly integrated with Satsuma’s existing systems and processes, without any compatibility issues.

Harris highly recommends Dot Compliance’s quality management software. “Our experience with Dot Compliance has been a very positive one,” she said. “The attention that is given to the customer and any issues that arise is very impressive.”

Satsuma’s success story showcases how well-implemented quality management software can transform operations, improve compliance, and drive growth.