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Regulatory Trends in Computer Systems Validation and Data Integrity

By March 6, 2023No Comments

RegulatoryThe Evolution of Gap Assessments, Remote Audits, Inspection Readiness and Remediation during the Covid 19 Pandemic

The Covid 19 pandemic created immense challenges for the Pharmaceutical, Biopharmaceutical and Medical Device Industries, and for companies researching, developing, and manufacturing Rx products around the world. In 2020 and 2021 (and to some degree, continuing today) all processes were dramatically impacted by the pandemic as many employees, consultants, and others were restricted from physically working in the office or manufacturing facility, resulting in skeleton crews and largely remote workers.

 

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