Article | July 19, 2022

Implementing Data Integrity To Improve Outcomes In Biopharmaceutical Manufacturing

Source: Project Farma

By Parla Hoelter, Manager, Jordan Krist, Consultant, and James Burback, Director, Project Farma

The fast-paced growth of the biopharmaceutical sector, coupled with increasingly data-driven regulatory decision-making, has rendered data integrity a core part of any biopharmaceutical company’s business strategy. Early integration of data integrity principles is especially key; the risks associated with uneven data integrity, as well as the costs of implementing a data integrity plan late in a manufacturing paradigm, can serve to disadvantage growing companies and promising therapeutics.

Time, money, and trust are all valuable resources for any pioneering biopharmaceutical company. The evolution of advanced therapeutics, and the commensurate evolution of regulatory expectations surrounding the data that supports their safety and efficacy, will require anticipatory solutions geared toward data integrity. This is especially crucial in the clinical manufacturing space, where standards are often less rigid than for GMP-scale manufacturing, and where neglecting to evaluate data integrity with that scaling in mind can create cascading problems as projects advance. Fomenting a comprehensive data integrity plan is also important for larger organizations, many of which may contract their manufacturing out to a network of CDMOs, each with its own unique approach to data.

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