Cloud computing is becoming more prevalent across all industries. In the highly regulated life science industry, cloud computing brings a whole new complexity to meet the Food and Drug Administration computer system validation, quality systems and 21 CFR Part 11 requirements. The first phase is to acquire knowledge of cloud computing, its services, environments, pros/cons, risks, and validation requirements. During Part 2 of this webinar, Holly Baldwin, UL senior validation advisor, further explores cloud basics to assist your QA and validation teams entering this new world of validation/compliance.
- Understand what should be validated/qualified in P2V transition
- Learn about vendor qualification and business roles and responsibilities for cloud-based environments
- ALCOA-data integrity and data security
- Implement and document your validation process
- Understand what should be monitored on an ongoing basis
- Vendor changes, patches, upgrades and security breaches
- Change control
- Periodic review
Holly Baldwin, senior vaildation advisor, UL
November 8, 2018
Uncovering Cloud Computing — Cloud Basics and Validation Part 2
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