MedCity News July 3, 2024
Harlan Knapp

Data exchange lies at the heart of innovation. With the right data available, BioPharma companies can best implement advanced analytics tools for timely interventions in manufacturing deficiencies and optimize processes.

Built-in data integrity is a bare minimum requirement in today’s BioPharmaceutical manufacturing. Good Manufacturing Practices (GMP) regulations of the Food and Drug Administration (FDA) highlight the importance of the accuracy and reliability of data across supply chains. Yet, the difficulty of achieving this milestone can still be underestimated by drug sponsors, especially when working with manufacturing partners.

Although organizations are expected to demonstrate full governance of their data across the product lifecycle, their access to process data remains limited, which hinders early risk detection as well as the...

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