Learn how to write a computer system validation protocol according to GAMP5 & 21 CFR Part 11. For more tips & download templates, follow us.
Select the appropriate test environments for computer system validation CSV according to GAMP5. For more tips and tools, follow us.
Learn what is a white box & black box type of testing in computer system validation CSV. For more tips & download templates, follow us
The Functional Requirement Specifications FRS describes the software product to be implemented in terms of the functions it will perform and the facilities required to meet the user requirements specifications.
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…
WHAT IS A VALIDATION PROTOCOL? A validation protocol is a written plan describing the process to be validated, including production equipment and how validation will be conducted. A validation protocol…
WHAT IS A VALIDATION PLAN? The validation plan (also called VP) is the most high-level document responsible to describe what, how, and when the validation activities shall be executed…
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…
Established in 1996, CIQA provides pharmaceutical validation engineering services, instruments dataloggers rental and much more.
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