Navigating CMC Data Challenges in Acquiring New Assets with QbDVision

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Navigating CMC Data Challenges in Acquiring New Assets with QbDVision

Challenge 1: Data Integration

When a new asset is acquired in the life sciences industry, CMC leaders often face the challenge of integrating the acquired CMC data with their existing systems. This process is complex and time-consuming as the data received may be unstructured, dispersed across multiple formats like PDFs, spreadsheets, and Word Documents. The task of harmonizing this data with the current CMC program can be overwhelming and requires meticulous planning and execution.

Challenge 2: Knowledge Management Discrepancies

One of the key challenges in acquiring new assets is dealing with different knowledge management frameworks. Organizations may have unique data labeling strategies and documentation SOPs, leading to inconsistencies in data structure and management. This can result in confusion and inefficiencies when trying to aggregate and utilize the acquired information. Implementing a robust knowledge management system and adhering to FAIR principles can help streamline this process.

Challenge 3: Tribal Knowledge Gaps

Another significant challenge for CMC programs when acquiring new assets is the presence of brain-sized gaps in tribal knowledge. Critical information essential for the product may only reside in the minds of CMC contributors, making it inaccessible to the acquiring organization. This lack of documentation can lead to crucial data being lost during the transition, impacting the overall success of the acquisition. Establishing proper knowledge sharing practices and documentation protocols is essential to address these gaps.

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