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 predicate rule, 211.68.
Also discussed were other regulatory agencies stance and advocacy groups like MHRA, PICs, and WHO, regarding Data Integrity (DI) and data compliance for regulated environments. Moreover, it also pertained the significant activity regarding regulatory notices (483’s, Warning Letters and Consent Decrees) on the subject of Data Integrity.
At PACIV we are at the forefront of both, the technological aspects of achieving Data Integrity as well as the regulations (FDA) for achieving data integrity compliance.
We help our clients achieve data integrity as well as compliance with other regulations and guidance such as FDA, MHRA, WHO and PIC/S.
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