How To Avoid Warning Letters For Data Integrity Nonconformances In Life Sciences

By David Jensen, Staff Writer, MasterControl

In 2018, the U.S. Food and Drug Administration (FDA) published its final guidance detailing how companies developing regulated products need to maintain and ensure the integrity of their data throughout the product’s life cycle. The bottom line is the FDA expects that all data be complete, reliable, accurate, and consistent. Data integrity is established where the data is stored and managed in its original form.

To be confident that no corners were cut or data was falsified in product development, the FDA expects manufacturers to ensure all data meets the guidelines outlined in the ALCOA acronym:

• Attributable - Easily identified to the person who collected the data, the data’s place of origin, and the time the data was collected.
• Legible - Data should be easily read for as long as the data exists.
• Contemporaneously recorded or a true copy - The date and time the data was collected should
• Original - The original data records need to be preserved throughout their life cycle, meaning the data storage processes and materials need to be durable.
• Accurate - Data needs to be error free and high quality. All changes must include supporting documentation.¹