Dear all,
Somebody known what is the contents in a validation summary report?
I need to create a validation summary report template but i don´t known what is the principal contents in this document.
thanks for your comments
YOu will need something like
Table of contents
Reference documentation
Scope
Introduction
Results of execution
Deviations noted
Observations
How to deal with Deviations and Observations (example some aspect might need a re-execution)
Final summary detailing the result of the validation
Hope this helps
Dear Oscar
U dont need to bother for it, simply a Validation Summary Report provides an overview of what was accomplished and concludes the documentation. Yes as advised above Results of execution,Deviations and observation noted should be covered, and on the basis of this the action plan is decided by validation team.
Regards,
Shahid Ali
QA Manager
Addis Pharmaceutical Factory SC. Ethiopia
Dear leolikelion,
on the first, pls…do not make the same mistake like many of your colleagues from Val. Dept.!!!
First of all, you need to spend some time into production area, to see what happen there, to work toogether with other people, to see, recognize and learn all about process there, machines, devices, enviroment, legislatives…etc, etc…
Once when you get a lot of expiriences, you could start validation.You need to KNOW how to do, also you need to FEEL.
It is not like just seat and write procedure. Much experiences, much learning…after that…writing.
rgds,
cubica:)