Overview

The Chemistry, Manufacturing, and Controls (CMC) Module 3 component of the Common Technical Document (CTD) required for pharmaceutical regulatory submissions requires extensive documentation, including drug substance and drug product information, manufacturing processes, analytical methods, stability studies, and more. Managing the manual transcription and compilation of this documentation consisting of text annotations, images, data, tables, etc. from various sources while ensuring accuracy, consistency, clarity, and coherence across different sections of the report can be very challenging and can often times result in data integrity errors and risks.

This webinar will provide valuable insights into:

• What is the value of using a Structured Content & Data Management (SCDM) guided workflow solution in biotech and pharmaceutical product development?
• Why are the CMC Module 3 data, content, and tables report generation challenges so difficult?
• How can I improve data integrity, minimize errors, redundancies, and discrepancies, while enhancing the reliability and accuracy of information of my CMC Module 3 and other e-Reports?
• Who can benefit from the Compass BIO® solution which can enable the automatic generation of complex data tables and reports and the ability to use a single set of When in biotech and pharmaceutical product development could a SCDM guided workflow solution be used?