GLAMS Impact Analysis automates labeling change management, boosting efficiency, compliance, and data transparency. It offers NLP-driven discovery, comprehensive impact assessment, and seamless integration with AMS and Regulatory Applications, reducing costs, time, and risks for the supply chain.
Introducing GLAMS Impact Analysis – an advanced solution for pharmaceutical product labeling change management. Seamlessly integrating with your existing systems, it ensures compliance, data integrity, and informed decision-making. With features like data tracking, quality analysis, and change assessment, it enhances visibility, accuracy, and efficiency in Regulatory product information safety changes. GLAMS Impact Analysis automates processes, reducing risk:
Automatic creation of a regulatory change impact assessment project
System generates list of impacted components with intelligent insight
System transfer approved impacted updates from source PI documents to artwork PDFs
System initiates mock-up and production artwork workflows from regulatory assessment
A single unified view of Regulatory and Artwork files and metadata
GLAMS Impact Analysis streamlines change management by using advanced algorithms and NLP to efficiently identify tracked changes in drug product labeling documents, saving time and effort in assessing affected assets.
Offers comprehensive tools to assess the impact of identified changes on artwork files, including modifications to text, format, and visuals. Its documentation features ensure clear understanding of the impact on artwork content.
Enhances change management by seamlessly integrating with your AMS. It automates the transfer of changes from labeling documents to artwork, minimising errors and enabling efficient workflows and notifications for artwork updates.
The Impact Analysis Solution auto-initiates workflows post-analysis, promptly notifying stakeholders for enhanced collaboration, faster task execution, and regulatory visibility during artwork updates.
Pharmaceutical
Veterinary
Nutraceutical
Medical Devices
