SaaS/Cloud Risk-Based Validation With Time-Saving Templates

Why Should You Attend:

This webinar will describe exactly what is required for compliance with Part 11 and the updated European equivalent Annex 11. It will take the concepts described in the regulations and expand them into specifics for all three primary compliance areas: SOPs, product features, and validation. Attendees will learn what is required for IT, SaaS, and cloud hosting. All required IT SOPs will be described. Product features based on the current industry standards will be explained in detail. The 10-step risk-based validation approach is outlined so that the specific documents for a validation project are understood.

Areas Covered in the Webinar:

• Which data and systems are subject to Part 11 and Annex 11
• What the regulations mean, not just what they say
• Avoid 483s and Warning Letters
• Explore the three primary areas of compliance: SOPs, software product features, and validation documentation
• Learn the requirements for IT, SaaS, and cloud hosting
• Ensure data integrity, security, and protect intellectual property
• Understand the current computer system industry standards for security, data transfer, and audit trails
• Electronic signatures, digital pens, and biometric signatures
• SOPs required for the IT infrastructure
• Product features to look for when purchasing COTS software
• Reduce validation resources by using easy to understand fill-in-the-blank validation documents

Who Will Benefit:

• Computer system users
• IT personnel
• QA personnel
• Managers
• Executives