Elevating Customer Quality with a Secure Cloud QMS Solution

SYSTEM USED

Arena QMS

Best Thing About Arena

The unwavering expert support, and guidance from Arena coaches are crucial in driving EVERSANA’s success

Bottom-Line Impact

Saves time by eliminating the need to manipulate spreadsheets to get information

Key Benefits

• Eliminate time-consuming manual processes

• Enable secure workspaces to meet individual customer needs

• Automate repetitive manual complaint handling and audit management tasks

• Reduce time spent generating training reports from hours to minutes

• Drive fast adoption and high customer satisfaction

• Gain deeper insight into client quality data with Arena Analytics

• Get expert guidance and support provided by Arena coaches

THE SOLUTION

To fortify their reputation of providing best-in-class regulatory and quality process support, EVERSANA chose Arena’s cloud-native QMS solution. “We selected Arena for its ability to create multiple workspaces with tailored access policies, enabling unique environments for each customer,” noted Laura Savenelli, Business Analytics Senior Manager, Quality, EVERSANA.

Within the workspaces, the EVERSANA team and the customer can manage changes, corrective actions, and configurations according to the customer’s policies and procedures, audit responses, supplier qualification process, and regulatory requirements.

With Arena in the driver’s seat, the company is exploring and utilizing many capabilities like the validate package for impact analysis. Arena Validate is designed to speed FDA 21 CFR Part 820 and Part 11 compliance as well as analyze the possible effects of a decision before implementing change. “We do a general impact analysis across all our customers and for our own validation. We utilize the user requirement specifications (URS) documentation provided by Arena to create our own trace matrix across the different validations. We also provide validation for customer specific configurations in their workspace when going live,” said Laura.

Before implementing Arena, conducting an impact analysis was manual—screen captures, click and drag into Excel. “Our customers couldn’t access the validation so we would pull it from the server and then email it to them,” noted Laura. “Everything is easier and accessible now.”

EVERSANA also utilizes Arena’s Automation capability to automate repetitive tasks and log all transactions for traceability. As an example, when the team encounters a product quality complaint (such as with a medical device), a complaint is issued with the return material authorization (RMA) number associated to the part to be tracked. Depending on the answers that are provided in the decision tree, Arena will automatically launch a service complaint, a customer complaint, or no complaint.

What’s more, the team uses Arena Automations to report adverse events. Recognizing and reporting adverse events and product quality complaints can identify and mitigate potential patient risks, reducing the chances of missing any important details related to the adverse event.

RESULTS

Arena has given EVERSANA a competitive edge: Because of Arena’s flexible cloud-native platform and EVERSANA’s commercialization model (that gives manufacturers full access to launch strategy, execution, and long-term outsourced services), the team can quickly onboard a new customer and provide a managed service offering even with tight deadlines and quick, go-live dates—something they were not able to do before Arena.

Laura said, “We’re able to offer customers an end-to-end commercialization strategy driven by Arena that will bring their product to market at a fraction of the cost of going alone. The customers perform their tasks in Arena, we manage all the user and system configuration and training. We’re here to support them every step of the way—they don’t have to hire an individual staff person.”

The transition from a manual, spreadsheet-based system to Arena has resulted in significant time savings, improved data integrity, and better regulatory compliance for EVERSANA’s customers. Laura explained, “Our customers and team have benefited from the time savings Arena provides. We no longer need to manipulate Excel spreadsheets to obtain information or track the history of a document or a quality process.”

Complete Commercialization Across the Product Lifecycle

With EVERSANA’s agile and effective commercialization strategy, Arena is helping the company partner with their customers to create real-world impact throughout the entire product lifecycle.

In a world that is rapidly changing, EVERSANA can evolve beyond traditional strategies while creating true impact for their customers.

Our customers and team have benefited from the time savings Arena provides. We no longer need to manipulate Excel spreadsheets to obtain information or track the history of a document or a quality process.”

—Laura Savenelli, Business Analytics Senior Manager, Quality, EVERSANA