Contradictions in Medical Device Verification vs. Validation - ISO 13485

tantan

Inactive Registered Visitor
#1
Hi, i am currently writing the SOPs for design control and am at a stuck with verification and validation. i have found lots of good sites with great definitions, inlcuding this forum but when i go to practically apply it I get confused. For example...validation is supposedly testing that the user requirements are satisfied...where eslewhere a verfication process will say convert user needs/ req to specs, develop a test protocol from this to verify design input to output. Isnt this a contradiction in terms as its essentially doing the same thing!?

Or could i look at it this way-requirements are composed of 3 aspects...functional, performance and interface requirements. These in turn are converted into engineering specfications. The testing of the functional components completes the validation, and the testing of the performance and interface requirements, as well as other means such as code walkthroughs etc completes the verification.

If anyone else could shed some light it would be greatly appreciated!!

Thanks

Tania :)
 
C

cuadra - 2010

Guest
#2
Re: contradictions in verification v validation

Verification:
The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether products, processes, services, or documents conform to specified requirements. The process of evaluating a system or component to determine whether the products of the given development phase satisfy the conditions imposed at the start of that phase.

Validation:
The process of evaluating software at the end of the software development process to ensure compliance with software requirements. The techniques for validation is testing, inspection and reviewing. Determination of the correctness of the products products, processes, services with respect to the user needs and requirements.

cuadra
 

Ajit Basrur

Administrator
Staff member
Administrator
#3
Re: contradictions in verification v validation

If anyone else could shed some light it would be greatly appreciated!!

Thanks Tania :)
Tania, in simple words,

Verification simply is the process where you come to know if its OK or not OK, while

Validation is the process to ensure that the steps when performed under the predetermined conditions give a satisfactory product. In short, this stands for reproducibility and can ensure an acceptable product over a given period of time.

Hope this clarifies.
 

Coury Ferguson

Moderator here to help
Staff member
Moderator
#4
Re: contradictions in verification v validation

If you are talking about ISO9001:2000 use the definitions in ISO9000:2000.
 

tantan

Inactive Registered Visitor
#5
Re: contradictions in verification v validation

im trying to harmonise our certified ISO 13485 to the FDA QSR...needs a much more detailed design control procedure, and im just trying to make sure I do it right!
 

Coury Ferguson

Moderator here to help
Staff member
Moderator
#6
Re: contradictions in verification v validation

im trying to harmonise our certified ISO 13485 to the FDA QSR...needs a much more detailed design control procedure, and im just trying to make sure I do it right!
I really am no expert in 13485, but the definitions stated in ISO9000:2000 are a good place to start. Does 13485 have a series that has definitions?
 

tantan

Inactive Registered Visitor
#7
Re: contradictions in verification v validation

i think the definitions are pretty similra. i think my problem is that intellectually i understand the definitions...it is when i come to applying it to how things are run in my company that im having problems...ie is this a verification document or validation document.For example, we have gone through and tested all the functions of the software program ie does file open when you hit file open, does file close etc...is this validating the functionality...or verifying the specfication that this is what must happen when a user hits file open..

this is why i am a bit confused...
 
K

Kiran Sridhar

Guest
#8
Re: contradictions in verification v validation

Tania,

I will give you the example:

Consider a mechanical part, like a sheet metal bracket. Here are the differences of verification and validation:

Verification:
I will inspect the part against the drawing, which includes material, dimensions, dimensional & geometric tolerances, finish. I am not bothered whether this part is performing well in the assembly or not, which is ultimately the user's needs.

Validation:
I will assemble the part onto the system; check for fitment and function. This is validation. Here, I don't have any drawings, but I have user needs in my mind.

I believe this example can be extrapolated to any extent.

Let me know if you have any queries beyond this.

Thanks & Regards,
Kiran
 

tantan

Inactive Registered Visitor
#9
Re: contradictions in verification v validation

thats a really good mechanical example !

does anyone have similar examples for software?
 

Coury Ferguson

Moderator here to help
Staff member
Moderator
#10
Re: contradictions in verification v validation

Let's look at the definitions:

ISO9000:2000 said:
Validation confirmation, through the provision of objective evidence (3.8.1), that the requirements (3.1.2) for a specific intended use or application have been fulfilled

Note 1 The term "validated" is used to designate the corresponding status

Note 2 The use conditions for validation can be real or simulated
tantan said:
For example, we have gone through and tested all the functions of the software program ie does file open when you hit file open, does file close etc...
This example, in my opinion would fall under validation. The objective evidence would be the testing of opening and closing the file.

ISO9000:2000 said:
Verification confirmation through the provision of objective evidence (3.8.1) that specified requirements (3.1.2) have been fulfilled

Note 1 The term "verified" is used to designate the corresponding status

Note 2 Confirmation can comprise activities such as

- performing alternate calculations,

- comparing new design specification (3.7.3) with similar proven design specification,

- undertaking tests (3.8.3) and demonstrations, and

- reviewing documents prior to issue
In my opinion, when you compare any other existing software programs to see if it does what the other proven software has done, you have verified the program.

These are in my opinion, and someone else might have a better understanding of the differences.
 
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