Data Integrity: A Vertical Journey
Data is an important factor that is reshaping the pharmaceutical industry and triggering significant innovation. Vertical integration of equipment can represent an optimal solution to manage the increasing flow of data efficiently, innovate the manufacturing environment, and fulfill data integrity requirements. Regulators and health agencies are strongly enforcing data integrity related requirements 1 , 2 and therefore have increased focus on how companies are managing data over its entire life cycle.
- 1US Food and Drug Administration. Guidance for Industry. Draft Guidance. “Data Integrity and Compliance with CGMP.” April 2016. https://www.fda.gov/downloads/drugs/guidances/ucm495891.pdf
- 2Medicines & Healthcare Products Regulatory Agency. “GXP” Data Integrity Guidance and Definitions, March 2018. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/fi le/687246/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf