Monday, April 6, 2020

21 CFR Part 11 Compliance for SaaS/Cloud Applications

21 CFR Part 11 Compliance for SaaS/Cloud Applications

 Events in USA
Online
2479 E. Bayshore Road Suite 260 Palo Alto, CA 94303, USA customercare@complianceonline.com webinarassist@complianceonline.com feedback@complianceonline.com
This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments. It details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Understand the specific requirements associated with local and SaaS/cloud hosting solutions. It details the requirements for HIPAA Protect Health Information (PHI) Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.

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