Verification Process for the existing MDS Product

Hirvo

Starting to get Involved
#1
Next question:
we need to create the Verification and Validation Process (for our cloud based software). The product has been developed about 6 years ago (a startup these times) and in use. Nowadays practically all the development tasks, which are done, are changes and improvements. What do you advise:
- Should we write the process as we were making a new project once again or
- should we write only the verification of the development tasks (for what we use agile method)?
- Or should we write the process as it was done (nobody knows anymore...:)).
 
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yodon

Staff member
Super Moderator
#2
You posted this in the 62304 forum so I presume you're aware of the content. Sounds like your best approach is to take the "legacy software" approach. Realize it's far more than just verification! You'll start by conducting the risk management activities, then define the safety class, then do a complete gap analysis. One of your gap closure activities will certainly be software system testing (verify that the requirements and risk control measures) are met.

Do note that prior to the discussion on legacy software, there is a general requirement that you have a quality management system.
 

Hirvo

Starting to get Involved
#3
Yes, we have a large risk analyse done. Just thinking how to create the documents. We have a Product Maintenance Process described and I wonder if that can include the verification and validation or do we need to have own document for that (I think it would be easier to read and get the big picture they are in the same document, but I was advised by a consultant to make a separate document about it - I wonder why...)
 

yodon

Staff member
Super Moderator
#4
From what you describe, I think I'd have to agree with the consultant. The Product Maintenance Process is just that - process. The verification and validation document(s) is(are) a set of protocols, test results, and reports (with conclusions). The Product Maintenance Process might call out that the V&V work is done prior to releasing an update but you want to let those protocols be managed independently of the Process.

Oh, and just to be clear, a gap analysis is not the same as a risk analysis. I presume you're aware of that but from the last post, I wasn't sure. The gap analysis may show that you don't have a (proper) software architecture document (per the standard). You would need to assess that gap to determine how to close it.
 

Hirvo

Starting to get Involved
#5
Thank you - sorry, I was unclear ...

At the moment we have
- V&V Process
- Product Maintenance Process

Records/documents/test results
- Verification reports

And my question actually was, if it is wise to write V&V Process, if we have same things described in the Product Maintenance Process...
 

yodon

Staff member
Super Moderator
#6
As far as processes go, my rules of thumb are:
  • Do what makes sense for your company (and meet the requirements, of course)
  • Don't duplicate information
Without knowing more, it would be hard to really say if you need both but sounds like there's room for improvement.
 
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