What is Lean Validation?
Validation is essential for product quality, compliance, patient safety, and more. It ensures manufactured products are a consistent quality while also providing evidence of this quality. It is also ensures systems perform according to specification.
Lean validation is about eliminating waste at all stages of the validation process.
How to Achieve Lean Validation
Strategic Approach
A strategic, high-level approach to validation where the goal is not just successful validation, but successful validation achieved as efficiently as possible
Stakeholder Buy-In
Buy-in from all those involved and accepting that, just because things have always been done this way, doesn’t mean they should be in the future.
Focus on Value
Questioning each step, process, action, or decision and asking if it adds value to the validation effort, reducing or eliminating anything that doesn’t.
Lean Validation Best Practices
- Class-Based Design
- Class-Based Programming
- Equivalency
- Build in Quality
- Automate
- Digitise Processes
- Paperless Systems
Read more about lean validation.