Jorge Rodríguez, PACIV’s CEO, recently presented the ISA Ireland Tech Talk “Data Integrity: A Practical Approach to Assessment and Remediation” at Rochestown Park Hotel, Cork, Ireland.
(TOP PICTURE FROM LEFT TO RIGHT: Billy Walsh, ISA Ireland Secretary, Jorge Rodriguez, PACIV CEO, John Murphy, ISA Ireland President, and Brendan Hyland, Business Development Manager/Director at PACIV Ireland.)
The presentation discussed how a practical approach to data integrity assessment and remediation may be undertaken within the Bio-pharmaceutical Industry.
Jorge presented a historical look at the regulations and gave a perspective on the progression over time of the expectations and approaches for Computerized Systems. The presentation also looked at how to establish a DI program (Planning, Assessment, Remediation, Maintenance) that embeds, as well as leverages, the new interpretation and approaches for DI within the existing CSV Life Cycle so it can be sustainable.
The presentation discussed the recent guidance’s to the Food and Drug Administration’s stance, as well as other regulatory agencies 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.