CIQA User Requirement Specifications
How to create an User Requirement Specification URS.
What is a user requirement specification? How to create a URS in 30 minutes or less. Learn more & download a free sample here.
Validation engineering topics: Installation Qualification, Operational Qualification, and Performance Qualification
CIQA Design Qualification
When is Required a Design Qualification?
What is the design qualification? How to create a design qualification before the next FDA inspection? Learn more & download a free sample here
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The 4 Most Common Types of Validations
TYPES OF VALIDATIONS 1) Prospective validation. It is the most common type of validation. It is used for establishing documented evidence prior to process implementation that a system does…
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How to create a Validation Master Plan in 5 steps.
INTRODUCTION: The validation master plan (also called VMP) is the most high-level document responsible to describe what, how, and when the validation activities shall be executed in your whole…
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