Digital Automation for Label Management

Vertical: Pharmaceuticals
Business Area: Digital Automation for Label Management

See how a large Pharmaceutical company drastically reduced label approval time to under 6 months with digital automation.

About the client

The client is one of the largest Pharmaceutical companies in the world with over $40 billion in annual revenues. The company is also responsible for giving the world medically important vaccines saving lives and improving healthcare across the world.

Business Need

Changing drug labels for medications already on the market is a lengthy, tedious process. Inefficiencies include a poorly defined approval process and vastly different label change laws in countries where the drug is sold. The client needed a streamlined and trackable process from the moment a label change signal was initiated all the way through approval, allowing each country to accept/deny the label changes.

Current situation and pain points

  • It takes the client over 6 months to approve a new drug label.
  • The company lacked clearly defined approval process tracking, resulting in inundating employees with emails.
  • Email volume resulted in unclear status of the approval, resulting in lengthy delays.

Solution

Using Appian, an innovative end-to-end workflow solution was created to support the label update lifecycle with the following objectives:

  • Provide a role-based simplified user experience that facilitated access to key information (process context, for example) when executing tasks.
  • Provide greater visibility and accountability from an end-to-end perspective into the status of each approval and review.
  • Maximize efficiency by improving the ability to identify bottlenecks and reduce compliance risks.
  • Enable mobile access to regulatory information.

Benefits

  • The solution is estimated to have reduced the new label approval cycle to under 6 months.
  • Headquarters had the ability to initiate label update submissions in real time, with country participants retroactively completing steps within a highly visible and tracked system to synchronize with real-world deadlines.
  • Inbuilt form validation in the system helped to reduce form-fill errors, improving accuracy and reducing delays.

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