Hi Everyone,
SOPs are very important documents to build a strong quality system. Let us discuss How to write SOPs, what should be included to avoid FDA audit ?

For example:
I think Procedures is the most important part in any SOP document.Before starting to write, decide the exact purpose of the procedure. Once you have decided the exact purpose of the procedure, make sure everything you write contributes to that purpose for the medical device you are developing.

Share what do you think!