I have some scenarios in my mind and I need to make sure which deliverables are necessary for the scenarios.
I will buy a SW for calibration of pipettes in the laboratory (e.g pipette tracker). I will install the SW on a PC which will connect to a server to store the calculated data. Some equipment is also connected to the SW to deliver some values like temperature, air pressure, humidity…
Also one scale (which is stand-alone qualified) will deliver inputs to the software for calculations.
I have read the whole GAMP 5 but it says nothing about eqipment which will run together with a SW.
Which documents do I need for the whole validation procedure ?
What is commissioning? How will I know when should I commission the same instrument mentioned in this post? We just unpacked the instrument came in from the vendor. How do I get started with validation/qualification now? I appreciate your time.