Risk based Computer System Validation for SaaS/Cloud/Local Hosting

Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable.

Why Should You Attend:

This session explores proven techniques that reduce validation project time, often to one-third. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. The 10-step risk-based validation approach is detailed so that the specific documents for a validation project are understood. Explore methods to decrease resource requirements, and make documentation more manageable and understandable. This often results in a savings of two-thirds the cost. Additionally, this course will help companies increase compliance and demonstrate how to use risk management to improve system performance and promote process improvement.

Areas Covered in the Webinar:

• Learn which documents the FDA expects to audit.
• Proven techniques that reduce software costs and implementation times.
• Increase corporate productivity and individual workforce member productivity.
• Efficiently create validation documentation.
• Requirements for SaaS and cloud hosting.
• Decrease resource requirements.
• Make documentation more manageable and understandable.
• Avoid 483s and Warning Letters.
• How to implement a computer system to gain maximum productivity.
• Use resources effectively to perform effective validation while avoiding doing too much.
• How to link requirements, specifications, risk management, and testing.
• Document a computer system validation project using easy to understand fill-in-the-blank templates.
• Based on: "Risk-Based Software Validation – Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).

Who Will Benefit:

• Computer System users
• IT
• QA
• Managers
• Executives

Instructor Profile:

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.

He has completed more than 230 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.