- This course will teach you how to reduce software validation costs by as much as two thirds.
- Â It details all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation
- The course is highly interactive, using real life examples and proven techniques
- You will learn how to use electronic records and electronic signatures to maximize productivity.
- This course will teach you how to prepare for an audit and is intended for IT, QA, laboratory, clinical, and manufacturing staff, as well as software vendors.
- The instructor starts with the basics and covers advanced concepts such as how to "Right size" change control methods that allows quick and safe system revalidation.
- Learn how to reduce testing time, and how prepare documents that avoid 483s and warning letters.