Validation of COTS Equipment plus Software

S

satwiks51

#1
Hi,

I am to validate an COTS analytical instrument for laboratory. The instrument is controlled by an user interface and data is stored in the instrument after the run. The data is now transferred to a computer where it is analyzed by a COTS software and the results are saved into repository.

Should the validation be done considering (Instrument + analyzing software) as a system or validation of Instrument and software should be separate.
 
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Ninja

Looking for Reality
Trusted Information Resource
#2
Howdy, (I am not in Pharma...so take all further comment with that in mind).

COTS analytical instruments do things.
COTS Software does stuff.
You need to accomplish something...and you need to validate how you did it to make sure it's OK. (The Test method, which includes both the equipment, tools, and how you choose to use them.)

Your validation should be on your "test method", which will unavoidably include the tools and equipment you use during the operation of your test method.
You aren't validating the COTS equipment.
You aren't validating the COTS software.
You are validating your test method and showing that it is adequate to meet the stated need.

HTH
 

Ninja

Looking for Reality
Trusted Information Resource
#4
LOL, thanks yodon...
FWIW, validating the test method validates the gage and the software at the same time, no?
 

yodon

Leader
Super Moderator
#5
You can almost certainly get some lift for the software validation off of the other validation activities but, as noted, software validation is more than just test. Confirmation of full lifecycle control is expected (the expectations assume, rightly, that software will change)
 
#6
Hi,

I am to validate an COTS analytical instrument for laboratory. The instrument is controlled by an user interface and data is stored in the instrument after the run. The data is now transferred to a computer where it is analyzed by a COTS software and the results are saved into repository.

Should the validation be done considering (Instrument + analyzing software) as a system or validation of Instrument and software should be separate.
GAMP 5 Category 3 software (for COTS) and USP 1058 would be a good start.
 

sreekiran14

Starting to get Involved
#7
I validated a COTS GAMP3 data analysis software by keeping the instrument software that generates data out of scope and planned to validate that separate to make things easy and clear.
 

sreekiran14

Starting to get Involved
#8
You can almost certainly get some lift for the software validation off of the other validation activities but, as noted, software validation is more than just test. Confirmation of full lifecycle control is expected (the expectations assume, rightly, that software will change)
I feel that you have good experience around the software validation,Can you please explain what do you mean by full life cycle control?
Thank you.
 
#9
I feel that you have good experience around the software validation,Can you please explain what do you mean by full life cycle control?
Thank you.
In short, from cradle to grave ... so in this case, refers to all the phases of a software throughout its planning, development, use, change control, through its eventual retirement
 

yodon

Leader
Super Moderator
#10
I feel that you have good experience around the software validation,Can you please explain what do you mean by full life cycle control?
Sure. Things change with software: either the software itself, the OS under which it runs, the hardware platform, 3rd party software incorporated, use models (more users, different use cases, and so forth. Any of these *potentially* impacts the validation status. All changes are ideally controlled but that's not always practical; e.g., OS security patches. Changes directly to the software absolutely need to be controlled. As @Ajit Basrur notes, cradle-to-grave management. This includes an ongoing (periodic) review of the validation status. You may likely re-do validation if the software is directly updated but will you do so if the use changes or an underlying database engine (for example) is changed? It *may* warrant additional validation work (whether it be testing or analysis).
 
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