Breaking Down Pharma's Silos For The Sake Of Data Integrity

By Petter Moree, Life Sciences Industry Principal, OSIsoft

The importance of data in pharmaceutical manufacturing cannot be overstated. The data captured during the process development is the lifeblood of any company, as it ensures the most critical elements used, such as raw materials, formulations, and workflows, are meeting the specifications set for a drug product. With the application of advanced drug production and testing techniques in pharmaceutical manufacturing over the last several years, regulators have become more vigilant in their oversight of data integrity, as unreliable and inaccurate data can mask serious quality and safety issues.

Specifically, data collected throughout process development as well as the manufacturing process must meet the data integrity principles of being attributable, legible, contemporaneous, original, and accurate. Also known as ALCOA, these standards are part of a framework defined by the U.S. FDA to ensure compliance of paper and electronic data.¹ Regulators want to make sure manufacturers have a system that not only provides access to data but also that the data itself is reliable, searchable, and interpretable. As the pharmaceutical industry strives to make a digital transformation through connected data, companies must figure out how to effectively use and share their insight with numerous other stakeholders across their network.