Validation of SW with Equipment

COMPUTER SYSTEM VALIDATION (CSV) SOFTWARE VALIDATION DOCUMENTATION
1

Hi Everybody,

I have some scenarios in my mind and I need to make sure which deliverables are necessary for the scenarios.

Scenario 1)

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 ?

Which regulations apply for USA ?

Which regulations apply for EU ?

Thanks all !
Cihan

2

GAMP5 provides general and overarching guidelines on software and automated systems validation.

If you need specific details on laboratory systems validation you can refer to GAMP guideline on Lab systems or GxP testing.

If you need any further details pease let me know.

Vanmeeganathan B
+91 9704500710

3

No one has ever validated a pipette calibration software?

4

Cihan

First you should layout a User requirements requirement stating exactly what you want this system to do.
List everything from how accurate you want it to be, to:what training is required to use it.

Once you have developed this URS and subjected it to peer review and company approval, you will be able to develop IQ/OQ/PQ protocols which will validate that your URS requirements are delivered.

Regards
Alex Kennedy

5

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.

Thanks,
Sacha