Medical Devices Company Improves Compliance Across the Enterprise

Varian Medical Systems, a leading medical device manufacturer, struggled with manual business processes. The new solution helped to automate approval processes, create an audit trail and improve compliance to meet FDA regulations.

December 22, 2021
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Overview

Varian Medical Systems, a leading medical device manufacturer, struggled with manual business processes. Adlib implemented a Business-Critical SharePoint solution where data is surfaced and shared from other existing systems via SharePoint across departments. The new solution helped to automate approval processes, create an audit trail and improve compliance to meet FDA regulations.

Solution

Varian Medical Systems, a leading medical device manufacturer, struggled with manual business processes. Adlib implemented a Business-Critical SharePoint solution where data is surfaced and shared from other existing systems via SharePoint across departments. The new solution helped to automate approval processes, create an audit trail and improve compliance to meet FDA regulations.

Benefits

Improved Compliance

The clear audit trail that now exists improves compliance significantly throughout the entire organization. The production of these compliant-ready DHF documents in support of FDA regulations has been improved due to the automation of the critical approval process.

Accelerated Business Processes

Now when the sales people need Design History File-related information, they can find it themselves via SharePoint instead of depending on another department. Everyone involved in the approval process now has enterprise-level visibility on the status of the approval process, including bottlenecks and next steps.

Reduction of Manual Work

Design History Files are now fully-text searchable, meaning that they can be easily located within SharePoint. Individuals are no longer required to manually assemble documents. This frees these employees to work on higher value, more interesting work. Documents in SharePoint which are ready for archiving can be automatically transformed using Adlib.

Time Savings

While detailed ROI is not yet available, the time savings is significant. Varian’s strategy is to buy, not build, so the Adlib purchase fit into this strategy nicely and the organization did not have to incur the costs of developing a solution themselves.

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