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2020 ISPE APAC Pharma Manufacturing Virtual Conference


AP20CESEP1/SES107 - Data Integrity in Quality Systems & Automated Technology


Sep 23, 2020 8:30am ‐ Sep 23, 2020 9:25am

Description

Data Integrity in Quality Systems & Automated Technology | Data Integrity is a global issue and currently a major concern with FDA and MHRA and all leading regulatory agencies. Multiple FDA warning letters, MHRA and EU GMP non-compliance reports have highlighted major data integrity failures and data falsification in companies globally. The agencies guidance for data governance has expectations for records in both paper and electronic form and with industry moving towards automation processes, there is a clear need for firms and responsible employees to understand the issues around data integrity and how to build robust systems in both QMS and automation systems.

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