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Validating 3rd Party Software which Tracks Archived Samples

M

Mare74

#1
#1
Hi there,

Our QA manager has given us the task of validating a 3rd party software that we use. It is a sample tracking software that has no affect on the final medical device quality but she wants us to prove it does what we want it to do which is track archived samples. Does she mean software validation or something else?? I'm confused...
 
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Y

yodon

Staff member
Super Moderator
#2
#2
Sure sounds like it... so why are you confused?

Please keep in mind that validation is more than just testing. In your case, does the vendor have a stable and predictable software development methodolgy (SDLC), does the vendor have the means to properly control releases, does the vendor have processes in place to adequately manage problems received and changes made, etc.?

Of course, part of validation in this case WILL be testing so you'll need defined requirements of how the system is supposed to work IN YOUR ENVIRONMENT (i.e., your intended use; not the vendor's list of capabilities).

Does that help?
 
sagai

sagai

Quite Involved in Discussions
#3
#3
Hi Mare! (and Yodon of course and all of us :) )

I assume your manager does have a reason why she asks such thing, presumably there may be an internal/external audit finding likely with an open CAPA about it or she sees a potentiality of it.
First I would suggest to clarify the original reason of this duty with her.

I also assume your company is marketing products in the US (but it almost not relevant in this general subject).

Not only the SW has effect on the finished device (direct) quality shall be validated, according to 61 FR 52602, for more see:
http://www.fda.gov/medicaldevices/d...rements/qualitysystemsregulations/default.htm

More precisely you can read the corresponding section of the CGMP at 21CFR820.70(i) see:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

Sum it up in this case if this sw is automate/store/etc. any part or subpart of your QMS process it shall be validated.

How ...

There is also a FDA Guidance (CDRH 938) see:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm

And yes, it does not help too much, but there is a detailed almost instructional "well known" method to apply and also still remain conform with CDRH 938, called GAMP, its recent revision is 5, as far as I remember.
See overview:
http://www.slideshare.net/rajsadare/gampriskbased-approch-to-validation
and have a copy from (there is a charge):
http://www.ispe.org/

and now hopefully you are prepared.

Only for informational purposes its also almost in the same way in ISO 13485:2003, see 7.5.2.1 last two paragraph (I think it was an addition to the previous revision of this standard), in this context do not forget about 4.2.4 of this standard.

Before you jump right into a deep water and start an exhausting work, I would suggest to consider the following.
ONLY when the sw system has relevance to CGMP (GxP respectively for collecting GMP/GLP/GCP for different industries) or the previously mentioned 7.5.2.1 section has to have a validated state IN ORDER to comply with regulatory requirements, otherwise I would qualify such work as a hobby in workplace.
I kindly suggest first to evaluate the GxP relevance of this SW first, and if yes, there is (actually it shall be even harder to determine this relevance) a relevance, then consider to use GAMP5 for its validation.

I am getting a long post, so I must stop now. :)

br
Sz.
 
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