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FAQs:
What is data integrity?
In GMP operations, data integrity ensures that data obtained throughout the manufacturing process is attributable, legible, complete, original and accurate (ALCOA). This is important to ensure that products have been developed following the correct processes.
In the early 2000s, FDA regulators became concerned that computer systems used for certain laboratory operations did not have the necessary controls in place. More high-profile findings included document shredding in manufacturing facilities, circumvention of data controls, and other deficiencies. Other global regulators and standards organizations, including the UK's MHRA and PIC/S, expressed concern about data integrity issues and published updated guidance and policies in recent years.
Data integrity remains a primary concern for FDA investigators conducting inspections of GMP sites and is a common 483 observation.
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