Qualio > Case Studies > Expression Therapeutics Streamlines Document Management with Qualio

Expression Therapeutics Streamlines Document Management with Qualio

Applicable Industries

Buildings
Pharmaceuticals

Applicable Functions

Facility Management
Quality Assurance

Use Cases

Inventory Management
Visual Quality Detection

Services

Testing & Certification
Training

About The Customer

Expression Therapeutics, Inc. is a fully integrated clinical stage gene and cell therapy company developing novel, potentially curative, therapeutics for deadly childhood and adult genetic diseases. The company recently built a 43,000 sqft state-of-the-art facility located in Westchester, Ohio to add in-house manufacturing capabilities for its product portfolio. In this facility, Expression Therapeutics is able to produce lentiviral (LV) and adeno-associated viral (AAV) vectors, cell therapy products, and recombinant proteins to speed up the development of their clinical programs.

The Challenge

Expression Therapeutics, a clinical stage gene and cell therapy company, was facing a significant challenge as it planned its new 43,000 sqft facility in Westchester, Ohio. The company was transitioning into a new phase of growth and needed to implement a modern quality management system that didn't rely on paper. The company's major investment in their Ohio operations represented a new phase of growth and Eric Day, Director of Quality Assurance, saw document control efficiency as their biggest challenge. The company was previously tracking deviations, CAPAs, and training in spreadsheets and hard documents, which was inefficient and time-consuming.

The Solution

Expression Therapeutics evaluated multiple eQMS vendors, considering their capabilities, pricing, and customer support. They ultimately chose Qualio for its powerful functionality and usability. The company believed that Qualio was the best way to move faster and more efficiently. As a data-driven organization, visibility into KPIs and metrics was a key requirement. With Qualio, the team could unite their data in one place and proactively pinpoint areas to improve. The transition from paper to electronic documents was aided by the Qualio+ team, who helped build system document templates to drive a consistent, controlled quality approach.

Operational Impact

Implementing Qualio's eQMS has helped Expression Therapeutics optimize their document management as they opened their new facility. The quality team no longer spends time on laborious document management thanks to Qualio’s digital repository underpinned by compliant e-signatures. The transition from paper to electronic documents was described by the quality team at Expression Therapeutics as 'in a word, excellent.' The company also enjoys ongoing support with its Qualio+ subscription, including help with creating events to track items beyond typical deviation and CAPA activities, such as cleaning schedules and procedures.