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PACIV at Data Integrity in Packaging Operations Workshop

Recently, Jorge Rodríguez, PACIV’s CEO, presented the “Data Integrity in Packaging Operations Workshop” hosted by the Institute of Packaging Professionals Puerto Rico Chapter at San Juan, Puerto Rico. The presentation discussed how Data Integrity compliance is captured within existing FDA Predicate Rules, how CFR 211.68 (“appropriate controls”) and 21 CFR Part 11 (“Scope & Application”) addressed approximately 95% of the Data Integrity requirements and the more cited topic within the “Data Integrity” related Warning Letters and 483’s is the Computer System Validation...

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