A “risk-based approach to computerized systems validation” has been a controversial industry topic since the release of Good Automated Manufacturing Practices, version 5 in 2008. The importance of this approach to validation cannot be overestimated, as it is the only acceptable means of meeting regulatory expectations in a way that is both compliant and cost-effective.
Almost ten years later, the vast majority of organizations have implemented “theoretical” processes define WHAT needs to be done, but do not explain practical components of HOW computerized systems validation efforts must happen in a risk-based environment. Too often this critical step is left to execution teams that may lack the necessary expertise, leading to uncertain levels of compliance, misplaced efforts, and uncontrollable costs.
The problems introduced by an inadequate risk-based approach to validation are countless, and include:
- Lack of clear process to determine what specific regulatory requirements apply to the system
- Lack of understanding of what needs to be done for the system to be considered validated
- Validation that takes too long and costs too much
- Testing that focuses too much on unimportant functions, while not focusing enough on important functions
- Lack of clear agreement when certain systems or project documents can be combined, etc.
Based on a wealth of real-life experience and laced with real-life examples, this course builds on Good Automated Manufacturing Practices mandates to define practical steps for a risk-based approach to validation. It specifically focuses on:
- Defining and controlling overall system validation scope and costs through System Risk Assessments; and
- Defining and controlling the level of system testing through Functional Risk Assessments
Additionally, this course will focus on:
- Common activities that are overlooked by validation teams
- Common mistakes made during a risk-based validation process
- Advice on how to streamline your validation efforts while ensuring compliance