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.”
In addition, the team uses Arena Analytics to help further support customers. With Arena Analytics, EVERSANA can track key metrics out of the box like how many nonconformance reports were generated in a year and the time to closure. Using the Analytics Designer, the team can create custom dashboards and gain deeper insights such as being able to review the number of scrapped items continuously over time, link scrap to a specific supplier, and determine the resolution. This deep level of information helps to quickly identify and address quality issues. Laura said, “We manage an audit program for one of our customers with over 1000 suppliers and hundreds of audits per year. Arena Analytics is critical for them to be able to see things quickly and immediately so they can react. It’s been a fantastic solution.”
EVERSANA also uses Arena Automations 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.
