Regulatory Operations

Improve internal monitoring of regulatory tasks.

Unify data and automate processes across systems and geographies.

Life Sciences leaders across the globe trust Appian.

A leading international clinical trial and health data company needed automated and on-demand process tracking that offered continuous updates as well as the ability to tailor their processes to comply with varying international regulations and to streamline their clinical trials process. They turned to our enterprise-grade platform for help.

 
  • Execute a more successful labeling management process.
    Appian provides a more comprehensive end-to-end review and management of the labeling process throughout the lifecycle of a pharmaceutical or medical device.
  • Process monitoring capabilities for distribution on local, regional and global levels.
    Unify safety information, health authority citations, manufacturing changes, and new research and development findings.
  • Drive visibility across the labeling process with simplified processes.
    Manage processes more effectively with unified data and interfaces to achieve effective label management.
  • Improve the registration process for medical devices. Integrate disjointed legacy systems into a single process to unify and manage the data. 
  • Effective management of thousands of external users with streamlined processes. Complete control and ability to manage numerous transactions with a high level of dependability.
  • Successfully manage your worldwide regulatory portfolio. Appian allows organizations to more easily improve submission quality and achieve regulatory compliance.
  • Take control of your regulatory processes. An efficient and controlled regulatory process to get your products in the hands of the patients who need them, fast.
  • Automate processes to allow for simplified data entry. Accelerate time to market for new products  with streamlined workflows and a unified interface.
  • Stay in front of regulations during and after new drug approval. Effectively develop and manage new and existing product information and registration for health and regulatory authorities.

 

  • Stay Informed of Changing Global Requirements. Ensure compliance and quality control over regulatory information across regions and countries.
  • Organize and Consolidate Your Data. Bring scattered data sources along with disparate procedures and systems into a single unified interface.
  • Ensure Audit Trails. Produce reports to ensure that procedures such as validation approvals and process checklists are being followed.

Lack of visibility and transparency was a large compliance concern for Merck, until they started working with the Appian low-code automation platform for end-to-end labeling.

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See how the Appian labeling application can offer value to your organization's regulatory operations.