Would an MRP system that has been in use for over 10 years require validation?

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William55401

Involved In Discussions
#2
If it is used for purchasing controls and for managing bills of material, I say yes it would require validation. I am not aware of any date related exemptions for QS related s/w.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
Would an MRP system that has been in use for over 10 years require validation?
I would think that you would have enough history to readily document its performance, etc.

Not directly related, but I remember a Motorola audit where the auditor started a write-up over a calibration issue of some kind of an instrument at some point in an old, well established process. We brought out something like 10 years of data showing that there hadn't been any problems (such as failures or customer returns or complaints). I think there was also a question regarding operators not using ground straps and none were provided. The auditor's concern was ESD related. When you have a lot of historical data there are some things that are proven.

:2cents:
 

yodon

Staff member
Super Moderator
#4
While the previos responses are good, do realize that validation is a continuous operation. Changes (more users, different use scenarios, additional capabilities, supplier updates, database engine updates, etc.) all need to be assessed for impact to validation. So yes, required; maybe suitable historical info to assert it's currently in a validated state; but that shouldn't be the end.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
While the previos responses are good, do realize that validation is a continuous operation. Changes (more users, different use scenarios, additional capabilities, supplier updates, database engine updates, etc.) all need to be assessed for impact to validation. So yes, required; maybe suitable historical info to assert it's currently in a validated state; but that shouldn't be the end.
I think that is always the case. Any change to a process requires a new validation, or an abbreviated validation of the aspect(s) changed. Do you agree?

I think of APQP - Most people think of APQP as ending as production starts, when in fact, APQP continues until a part is totally out of production.
 

mihzago

Trusted Information Resource
#7
Validation is required. What may not be required is testing. Many people are confusing validation with testing and are often overdoing it.
Validation comprises variety of activities (e.g. define requirements, assess risks, vendor assessment including review of their documentation if available), which is continuous as others stated; testing is only one part of it.

As part of your validation, you'll have to answer the tricky question of why you didn't perform it prior to the use and how do you know that the software worked OK for the last 10 years.
 
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