Hi could someone suggest how to validate adverse event reporting system.
Is it homegrown or COTS? Not that it matters, start with a user requirements document and go from there.
whether it is inbuilt or cots you have start from the user requirements.Could you please suggest me what will be the user requirements for aers.
The URS must document what the end user wants the system to do. So it is rather obvious that the system is very bespoke and the URS must be drafted accordingly.
Alex Kennedy
The 10-step Risk-Based approach to validation uses fill-in-the-blank Word templates. It asks all the right questions and can be used for any computer system validation. I’ve used it 192 times. It is much more understandable than GAMP or V-model descriptions. Check out
the go to Books and you will see it. And yes, it too starts with a User Requirements document. But it gives you the template for making that document in about one hour.