Data Integrity for GMP records refers to the completeness, consistency and accuracy of data. Complete, consistent and accurate data should be “Attributable”, “Legible”, “Contemporaneously”, recorded, “Original” or a true copy, and “Accurate” (ALCOA). Such data to be acceptable for this purpose must be reliable and accurate over its entire lifecycle. Data Integrity has been a common issue that is found during FDA inspections.

When FDA finds any invalid or unreliable data during the inspection, it is considered by the FDA that the product is adulterated as per 21 CFR part 210/211, part 820. GMP data is the evidence for assuring that the products are produced as per GMP regulations. At the end of this course you will learn:
• Know what Data Integrity is, and be able to detect Data Integrity Issues in advance,
• KNOW How can Data Integrity Risks be Minimized
• KNOW What Controls could be in place reducing the risk for Non-Compliance
• Know Common errors to avoid them
Language Course: Spanish