FDA Releases Data Integrity Guidance in Q&A Format

The FDA issued final guidance on Wednesday on data integrity and compliance with current good manufacturing practices.

Commissioner Scott Gottlieb said the agency revised its recommendations in response to stakeholder requests for more details. “The revised recommendations are aimed at helping manufacturers address identified data integrity lapses, implement best practices to address gaps that can create risks to data integrity, and ensure consistent awareness and commitment to ensuring data integrity,” he said.

Data integrity requires data to be “attributable, legible, contemporaneously recorded, an original or true copy, and accurate,” or ALCOA. Data integrity is critical throughout the lifecycle of CGMP data, from creation to disposition of data after the end of the record’s retention period, the agency said.