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Three Issues Hindering the Life Sciences Labeling Process

Victoria Ebel, Appian
March 22, 2019

In the labeling space, security, quality, and speed are essential to get the job done right. Unfortunately, they are not always easy to accomplish. Within the landscape of ever-changing regulations, adverse events, branding standards, and global influences, organizations need a concise system in place to ensure their labeling process is executed correctly and efficiently.

Without an innovative approach to labeling, life sciences organizations are sure to struggle with these three issues:

1. Compliance Life sciences organizations face unique regulatory requirements for each market where their products are sold across the globe. Failure to rapidly respond to these varying regulations can result in lost revenue, product supply disruptions, and fines. To comply with these regulations, companies have to ensure that all labels they are distributing match the appropriate compliance at all times.

The constant effort put forth by organizations to keep up with compliance on a global scale is draining their resources. To lessen their burden, companies need a solution that meets compliance standards and is flexible enough to adapt to changing requirements across regions. A platform that can help automate and standardize this process is a must for those struggling to juggle the many aspects of labeling compliance.

2. Label Changes Adverse events, new product introduction, and alterations in branding and manufacturing processes can all trigger label changes. Companies have to go through the entire labeling process each time a change is needed, sometimes multiple times each year. These changes require time, money, expertise, and coordination to execute, and the longer they take, the longer products are out of market and out of the hands that need them.

An efficient labeling process is needed to make crucial label changes, fast. Implementing a solution that can automate redundancies, provide step-by-step process management, and interact with all necessary systems, will drastically accelerate time to market, getting valuable products to patients faster and cutting out costs incurred from waiting to launch.

3. Process Inefficiencies For life sciences organizations, managing and editing core datasheets (CDS) and labeling artwork for thousands of products typically involves many systems across several regions. With the huge amount of assets stored in disjointed systems and being sent among tons of collaborators, it can be difficult and at times impossible for organizations to manage. With all of these segregated processes and interactions, organizations risk working with inaccurate or outdated information.

To better orchestrate these processes, data, assets, and collaboration must all be unified. A streamlined approach is the best way to do this. A platform is needed to help integrate these siloed processes together with asset management and collaboration capabilities to establish a seamless and efficient experience.

Implement an Impactful Solution

Appian's low-code platform offers a solution that provides end-to-end review and management of the labeling process throughout the lifecycle of a pharmaceutical or medical device, from early product development through product delivery and pharmacovigilance. The system enables process orchestration, with automated workflows that provide timely, transparent views across processes, enhanced collaboration capabilities, and unified interfaces.

See Appian's labeling solution in action with this demo teaser video:

Appian's labeling solution can help organizations:

    • Tie together safety findings, health authority citations, manufacturing changes, and new research and development findings into label creation

    • Simplify extensive processes by offering situational awareness and clear notifications when there is a threat for bottlenecks

    • Manage the creation and maintenance of all product related data, artwork, and updates throughout the product life cycle

    • Access process monitoring capabilities for distribution on local, regional, and global levels

To see more of what Appian's low-code platform can do for life sciences, visit our resource page.