21 CFR Part 11 - Compliance with SaaS/Cloud Software Applications 2018 is a webinar that covers topics such as:
- What the regulations mean, not just what they say
- Which data and systems are subject to Part 11 and Annex 11
- Requirements for local, SaaS, and cloud hosting
- Avoid 483 and Warning Letters
- How to use electronic signatures, and ensure data integrity, and protect intellectual property
- Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures
- Product features to look for when purchasing COTS software
- SOPs required for the IT infrastructure
- Reduce validation resources by using easy to understand fill-in-the-blank validation documents
21 CFR Part 11 - Compliance with SaaS/Cloud Software Applications 2018 is intended for:
- IT
- Computer System Users
- QC
- QA
- Managers
- Laboratory Staff
- Auditors
- GMP, GCP, GLP Professionals
- Software Vendors
