“We’ve never had a user specific action oriented system until Zen. 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.”
-Danielle Feingold, QA Analyst, Baim Institute
About Baim Institute
The Baim Institute leverages resources and 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.
Due to the nature of Baim’s business, they are audited regularly both internally, as well as by their industry sponsors. The quality management system is complex due to the unique business needs and 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.
Selection and Implementation of the Electronic Quality Management System
Prior to Danielle joining Baim nearly two years ago, the Quality team was comprised of half a dozen quality specialists and an equal number of point solutions. The business relied on a legacy Learning Management System (LMS) to manage training requirements but the system was unable to manage documents and e-signatures so they had to document all training in a paper-based system as well. It was a cumbersome process to say the least and Danielle was spending a significant amount of her time communicating to all staff the status of their team’s compliance and training status. And hosting audits was difficult where simple auditor requests could take significant time to respond to. It was clear that Danielle and the legacy systems were not going to be able to scale to meet their growing business needs.
The team at Baim selected ZenQMS due to the platform’s ability to hold individuals accountable for their ongoing training requirements as well as the ease of making changes to the training curriculum and updating the matrix. The implementation was started prior to Danielle’s involvement, but the process of migrating years of documentation and training requirements to the ZenQMS system was effectively and accurately completed within a month, with the help of the ZenQMS team.
Following the implementation of ZenQMS, Danielle reported an immediate and significant improvement in communication between departments as well as 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.” And she is now able to easily access a real-time view of compliance by department and for the business overall so she can provide regular updates to the executive leadership team.
Baim sets quality-related KPIs (key performance indicators) at the department level and ZenQMS has enabled the quality team to implement them, roll them out to the departments and report on statuses easily within a single platform. Danielle added that, “We’ve never had a user specific action oriented system until Zen. 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 (which feed my internal audits).”
The quality team at Baim plans to expand their usage of ZenQMS to leverage the Supplier qualification and Audit modules to best track and develop the Vendor Management function of the Quality Department. Whereas Baim Institute interfaces with a multitude of sites and vendors, the capability in ZenQMS to complete vendor management and the tracking of clinical sites will be beneficial in streamlining the various services that Baim Institute provides.