Category: CSV/CSA

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CSV – Effective System Level Risk Assessment

Presented By: Rohit Tyagi, President, SAGAX TeamKey Highlights:Regulatory Compliance: How implementing robust CSV processes is essential for pharmaceutical companies to ensure product quality and patient safety, while remaining compliant with regulations. Risk Identification: Learn how to properly assess risk in using a computerized system focusing on patient safety. Data Integrity Assurance: Identifying potential DI impact […]

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Understand the Applicability of FDA’s Computer Software Assurance Guidance to Data Integrity

“Computer System Validation” (CSV) has remained mostly unchanged for the past two decades. General Principles of Software Validation (GPSV), issued by the FDA in 2002, has been and continues to be the primary tool industry uses as guidance on this topic. CSV, as it stands today, is a documentation heavy exercise Documentation is done at […]

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APPLYING CSA CONCEPT TO DATA INTEGRITY – Updates on ISPE GAMP GPG DI & CSA APPENDIX

There are two parts to this webinar: 1) CSA and data integrity GPG DI alignment; and, (2) Insert more data integrity so we don’t bore people with CSAHear directly from the source, FDA – Industry CSA Team & Colleagues in a Panel setting discussing the upcoming ISPE GAMP Good Practice Guide (GPG) Data Integrity (DI) […]

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