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Customer Story | Baim Institute

About BioAgilytix

The Baim Institute for Clinical Research is an innovative, non-profit academic research organization that engages experts across a diverse network of medical and teaching institutions to enhance design, management, and data analysis for clinical trials in the United States and abroad.

Baim undergoes regular audits, performed both internally and by their industry sponsors. The quality management system (QMS) is complex due to the unique business needs and key performance indicators (KPIs) of each site, department, and contracted service. Hence, Baim’s QA Analyst, Danielle Feingold has her hands full as she is responsible for managing and reporting on the overall compliance of the business.

Success Highlights

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Business Need

Prior to Danielle joining Baim over two years ago, the Quality team consisted of six quality specialists and an equal number of home-grown tools. For instance, the Institute relied on a legacy Learning Management System (LMS) to manage training requirements. However, because the system was unable to manage documents and GxP-compliant electronic signatures, they had to document all training on paper. This cumbersome process meant Danielle spent a significant amount of her time communicating the team’s compliance and training status to staff members, rather than having a system with individual dashboards that users could update on their own.

Additionally, hosting audits was difficult because even the simplest auditor requests couldn’t be resolved quickly. It was clear to Danielle that their patchwork collection of tools couldn’t scale to meet their growing business needs.

Implementing ZenQMS in 30 Days for Enhanced Operations and Compliance

The team at Baim selected ZenQMS due to its ability to hold individuals accountable for ongoing training requirements, as well as how much easier it was to change the training curriculum and update the matrix. With the help of the ZenQMS team, Baim accurately and effectively implemented the system within a month.

“For the cost, it’s been incredibly effective in scaling to meet the needs of our business.” 

Business Impact

Following the implementation of ZenQMS, Danielle reported an immediate and significant improvement in inter-departmental communication, especially between the Quality team and managers/supervisors. She noted that, “For the cost, it’s been incredibly effective in scaling to meet the needs of our business.” She is now able to easily access a real-time view of compliance, organized by department and the business overall, so she can provide regular updates to the executive leadership team.

Because Baim sets quality-related KPIs at the department level, ZenQMS has enabled the Quality team to implement and roll out processes to the departments and report on statuses easily within a single platform. Danielle added, “We’ve never had a user-specific action-oriented system until ZenQMS. Whatever you put in you can also get out. That makes it a lot easier to track progress on individual users but also on a department level.”

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