regulatory labeling process automation

Is Process Automation the Future of the Pharma Regulatory Labeling Process?


Label changes for pharmaceutical drugs can occur for a variety of reasons, such as updates to dosage, formulation changes, new safety information, etc. The Pharma regulatory labeling change process is heavily regulated, requires strict adherence to country-specific laws and regulations, and involves a collection of complex workflows to coordinate tasks and activities across a large team spread globally.

Since label changes involve multiple stakeholders, and require approvals across the globe, it is time-consuming and complex when done manually, and can lead to errors, unnecessary delays, and increased costs. The amount of time it takes for pharma companies to change a label on a drug can vary depending on the complexity of the label change and the regulatory requirements in different regions.

The current state of the regulatory labeling process

The label change process can take several months or even a year to complete with extensive documentation, regulatory approval, and communication with healthcare providers and patients. Furthermore, if label changes require updates to marketing materials and packaging, it can add to the time needed for the process.

Often the label change process is executed in silos of systems and processes that are specific to various countries involved. This makes it impossible to get a unified view of a label change request that spans multiple countries, monitor its progress, identify potential delays proactively, and take appropriate actions to avoid delays.

Business drivers for managing label changes

The label change process is crucial for pharmaceutical companies as it directly impacts patient safety, regulatory compliance, and product information accuracy. The key business drivers for the label change process in a pharmaceutical company include the following:

      • Label information must be accurate and up to date.
      • Label changes adhere to strict regulatory compliance, specific to the applicable health regulators.
      • Label changes must be made in a timely manner.
      • All stakeholders need to be aligned, so label changes are communicated effectively.
      • Label information is translated and localized appropriately for each market.
      • Maintain consistency across labels for each product, including packaging inserts, patient information leaflets, and labels for different dosage forms.
      • The status of managing label changes across all countries for a specific product is monitored closely and communicated well to all stakeholders.
      • Any possible delays are identified proactively, and appropriate action is triggered to minimize delays.

A structured label change process is crucial for pharmaceutical companies as it directly impacts patient safety, regulatory compliance, and product information accuracy. It is critical to ensure that the label information is accurate and up-to-date, any changes to labels follow strict regulatory compliance, and audit trail, and must meet the statutory requirements in a timely manner. This is the reason why pharmaceutical companies are looking to modernize their label change processes.

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The modern approach toward labeling process automation

regulatory labeling process automation

In light of the above challenges and business drivers, Low-code process automation is particularly relevant to the pharmaceutical label change process. It is an approach that enables businesses to create applications and automate business processes that integrate in real-time with your current and legacy systems with minimal coding effort.

This approach typically involves the use of drag-and-drop interfaces and pre-built components to quickly create applications that can automate processes and workflows, bring data from various systems together, automate decision-making via configurable rules, provide deep insight into processes via interactive dashboards and deliver a modern, mobile-enabled user experience in a short period of time. The goal is to improve efficiency, reduce errors, and enhance compliance.

In the context of pharmaceutical label changes, process automation can reduce the time and effort required for label change activities, granting full transparency into the process, and ensuring that the label change process is compliant with regulatory requirements such as 21 CFR Part 11.

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Pharma regulatory labeling process automation – a Case Study

Our client – a global Fortune 100 pharmaceutical company adopted the process automation approach to streamline the clinical labeling workflow process. Learn more about the label change workflow project >

After transitioning to the automation approach, they observed the following changes in the process:

      • Cut cycle time by 50% – Our client reduced the new pharma drug label approval cycle to under 6 months which was previously around 12 months.
      • Centralized global label change – Our client was able to configure the label workflow specific to each country’s regulatory guidelines which previously lacked a clear and defined tracking process for approvals, resulting in employees having to work with a high volume of emails.
      • Reduced errors – Features like built-in form validation in the system helped reduce form-fill errors, improve accuracy, and reduce delays.
      • Unified data – Our client gained deep insight into the label change process through access to the right information and documents at a global level.

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8 steps to automating the Pharma label change process

Here’s how to approach pharmaceutical label changes using Low-code Process Automation:

      • Understand your current label change process by assessing existing systems, actors, and stakeholders. Articulate business drivers for the labeling automation initiative, pain points that need to be addressed, and current levels of the key business metrics and their targets.
      • Map out the process, identifying human involvement, redundancies, and potential errors.
      • Define automation requirements, including workflows, business rules, data integrations, and reporting requirements.
      • Choose a suitable low-code automation platform with input from your IT team.
      • Design data models, workflows, forms, and business rules on the chosen platform.
      • Develop and implement all components of the solution as designed and ensure it is performing as expected.
      • Thoroughly test and deploy the solution for the label team to start using.
      • Continuously monitor and optimize the solution for improved efficiency and outcomes.

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Benefits of automating the regulatory labeling process

Here are the benefits of modernizing the pharma labeling process using Low-code Process Automation:

      • Pharmaceutical companies can reduce the time and resources required to manage labeling compliance, creating significant transparency and cost savings.
      • Automation improves accuracy and consistency in the label change process, reducing the risk of errors and non-compliance.
      • Automated processes ensure that all steps are followed consistently and correctly, every time. With a built-in audit trail, it’s easy to be fully compliant with local regulatory guidelines.
      • Manual tasks such as data entry, checklists, and email approvals can be eliminated thereby reducing the overall time taken to make the label changes.
      • Pharmaceutical label change process automation improves collaboration and communication among stakeholders involved in the label change process.
      • Automated workflows ensure that all stakeholders are informed of changes and approvals required, reducing the risk of miscommunication and delays.
      • All stakeholders in the process gain real-time transparency into the process and can easily monitor label change requests for each country, from anywhere on any device!

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Watch a solution demo!

At Princeton Blue, we understand the challenges of managing global label changes and we have successfully delivered complex label change management solutions for our pharmaceutical clients. We invite you to watch the Labeling Solution Demo to see how Low-code Process Automation can automate and streamline your labeling process.

With over 14 years of experience working with the world’s largest pharma companies, we have the expertise to help you automate your most strategic Lab, Clinical, Regulatory, and Manufacturing processes. Feel free to contact us to brainstorm further.

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