You should create some documents
a) Description of the application, how the instrument is used, and what instrument functions and limits required for the application.
b) Test plan and protocols. If you have done some testing in the past you can refer to that documentation, but just a statement “The equipment has worked fine’ is not sufficient
c) Develop change control procedures and a procedures for on-going testing
(PQ) and for requalification
d) Write a summary report with a statement “The equipment is qualified from xx.xx.xxx (date)”. The report should be signed by QA.
