At Optimum Quality we focus on paperless validation of computerized systems (CSV), according to ISPE’s GAMP® 5 Second Edition. We use MS Azure DevOps and Modern Requirements and apply Critical Thinking. We have moved from document to content, and from system related requirements to integral requirement management. This makes our validations highly effective, efficient and sustainable, reducing the effort by 50% or more. We also provide services regarding Quality Management Systems and Quality Procedures, like for event, change and deviation management. We do this primarily for the Life Science Industry, in The Netherlands and abroad. We seek the balance between what you want to do yourself, and what you want us to do for you. Together we find the optimum. We look forward to hearing from you for any relevant matter.
