2018 - 10-Step Risk Based Computer System Validation for SaaS/Cloud/Local Hosting

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).