Level of validation for using computer system in inventory management

GOOD MANUFACTURING PRACTICE (cGMP) RISK ASSESSMENT
1

hi
we have been using computer system in inventory management (API/pharma Industry)
what is the level of valiation requirement? and how to achive it?
can any one put a light on the requirement
pl.

2

As you mentioned that the computer is used for inventory. Low level of validation is required in this case. You can develop a protocol or working Instruction which includes your daily calculations with the predefined acceptance criteria and frequency of performing the validation. I feel this will suffice your requirement

3

I don’t necessarily disagree with pradeepmanglani but I would hesitate to immediately conclude a low level of validation. The level of validation should be commensurate with the risk of using the system. If there’s a chance that using the system could allow, for example, quarrantined supplies in production, then the risk is a bit higher. If the system includes electronic record / electronic signatures, then the level of validation also goes up (for part 11 compliance - presuming this is FDA regulated).

You’ve given only a glimpse of the system so, IMO, determining the level of validation with just this information is, well, risky. :slight_smile:

4

[quote=yodon]I don’t necessarily disagree with pradeepmanglani but I would hesitate to immediately conclude a low level of validation. The level of validation should be commensurate with the risk of using the system. If there’s a chance that using the system could allow, for example, quarrantined supplies in production, then the risk is a bit higher. If the system includes electronic record / electronic signatures, then the level of validation also goes up (for part 11 compliance - presuming this is FDA regulated).

You’ve given only a glimpse of the system so, IMO, determining the level of validation with just this information is, well, risky. :)[/quote]
I agree with Yodon and as mentioned only a glimpse of the system has been mentioned. Ofcourse if it includes electronic signatures / records that has to comply with 21 CFR part 11. But if it is only an inventory then few checks will suffice the purpose.

5

You may assess the risk first, then You will be informed what level of validation should be performed.

That’s my advice.

Bart