Advantages of a Global Bioanalytical Laboratory eQMS – Beyond Regulatory Compliance

KCAS Bio launched an initiative to advance its Quality System through a 21 CFR Part 11 compliant electronic Quality Management System (eQMS) to be prepared for anticipated future regulatory requirements for Good Laboratory Practice (21 CFR 58). This was driven by the proposed rule from August 2016, the FDA is expecting a “complete Quality System approach,” to support the substantial growth and real-time information needs of a global CRO, using quality to define, guide, and advance its operations to continue to meet client needs in the CRO bioanalytical, biomarker, and analytical space. 

Harmonizing a Global eQMS Across Sites

In 2022, KCAS Bio implemented the last phase of eQMS. That same year, KCAS Bio acquired two bioanalytical and biomarker operations, one in the US and one in France. The last phases of deployment of the consolidated global eQMS culminated at the end of 2024, such that beginning in 2025, all KCAS Bio sites will be fully implemented on the same eQMS platform. The harmonized eQMS has many advantages beyond just the regulatory space. 

Streamlined Document Management

One of the advantages observed by implementing the eQMS platform across all sites is the eQMS Document Management process. The ability to quickly view, compare, edit, and ensure all operational sites are working in the same Quality System has accelerated the ability to develop and implement a unified Global Quality Policy, Global Quality Manual, and Global SOPs, making these controlled and available at the user’s fingertips. With access to view the most current documents on the system, all sites are able to perform work according to the same processes and procedures with the most up-to-date documentation. This promotes consistency and alignment across multiple sites and has driven consolidation of processes and communication. In addition, newly created and updated documents move smoothly through a workflow with the document owner, reviewer(s), and approver all on the same platform with tasks automatically moving forward to the next person in the process. As soon as a document such as an SOP is approved, it automatically moves into the preassigned roles and onto the trainee’s quick view dashboard of tasks.

Enhanced Training Capabilities

The eQMS has accelerated operating capacity by utilizing multiple modes of training. One of these modes provides training courses that can be recorded once, allowing the trainer more time to spend on other activities for the company. Individual staff can easily see training assigned to their role on their personal eQMS dashboard. Training completion is easily viewed such that Principal Investigators and/or Study Directors can quickly view who has completed the training necessary to complete work on projects.

Efficient Audit, Investigation, and CAPA Management

Audits, deviations/investigations, and CAPAs are completed in the eQMS. This also improves capacity as the auditee/action owner does not have to spend time locating the open audit, deviation/investigation, or CAPA in a file server (or on hard copy paper), as it appears automatically on their task list. As the workflow moves through actions and tasks for respective roles, the assigned actions appear on the user’s dashboard and a notification email is sent to alert the user that they have a task assigned.

Streamlined Supplier Quality Management

Supplier Quality Management is a part of the global eQMS. Global suppliers can be approved once in the system, with accessibility to all sites. All suppliers are viewable, whether approved or rejected. This reduces the time spent on qualifying an already approved supplier. Supplier reassessment is programmed into the record and can be easily viewed in reports from the system to ensure these occur timely.

Real-Time Oversight and Continuous Improvement

Real-time open tasks can be viewed across the company by management to ensure staff are completing their assigned tasks. Cross-functional teams can view open items to view the status’ and who is assigned and next in the current workflow.

Overcoming Challenges and Achieving Growth

Having the eQMS up and running has increased capacity to allow more time to focus on meaningful information such as real-time trending of deviations and audit findings which feed back into the Quality System for continuous improvement activities across the Company. Turnaround time metrics can be pulled across the business. As an example, the eQMS has improved turn-around time for deviations 4-fold, as compared to metrics prior to eQMS implementation all while KCAS Bio has continued to grow its business internationally. 

“The overwhelming challenge of implementing such systems is often met with reluctance and concern for a successful outcome. Time, resources, costs, and culture are all impacted as the organization goes through the journey of coming together. However, with expert leadership and tenacity to not shy away from the implementation challenges, the outcome is worth the investment,” said John Bucksath, CEO

A Commitment to Quality and Growth

KCAS Bio’s global eQMS implementation initiative was led by Sr. Director, Quality, Tracy Clark-Stovall, M.S., along with site Quality Assurance Directors, Todd Forsyth B.S. (Philadelphia, US) and Isabelle Valerino-Corler, M.S. (Lyon, FR). 

KCAS Bio has grown substantially since 2017 with almost 400 staff today, three sites across the globe, with advanced laboratory facilities and equipment providing services globally across all aspects of therapeutic products and developmental milestones. A critical foundation in the successful growth is the evolution of the quality system and its ability to continually advance with the needs of the Company to meet the industry’s requirements. KCAS Bio is positioned to meet upcoming regulation changes, support growth, and support clients’ increasing needs and expectations for quality in all that we do to provide and support drug development services to the industry.