7.5.2.1 Validation of the Application of the Computer Software - PLEASE CLARIFY

N

NikkiQSM

Quite Involved in Discussions
Much help needed my friends...

I have been reading through related threads through-out the Cove regarding the end of 7.5.2.1 - "The organization shall establish documented procedures for the validation of the application of computer software...."

I have read through one thread that says the clause is talking about the computer software used to make the product.

And I have read another that states it is the software installed in the product.

Can someone please just tell me which on it is refering to?

We produce plastic pellets - our extruders use computer software. So I am assuming that that is the software I would validate?

Thanks for the help in advance!
 
Y

yodon

Leader
Super Moderator
No stupid questions. :) But have patience.

7.5.2 is "Validation of processes for production and service provision" so this is indeed talking about the software used in the production of the product.

If you are applying 13485 then the extruder software would fall under this clause.
 
W

widetrack

I find that the software which accompanies a piece of inspection equipment which I use is the same as the equipment itself in that I do not question it. On the other hand I build a program which actually instructs the machine to acquire dimensions from a product we make. That piece of software must be evaluated to assure it is achieving the desired goals of CORRECTLY checking a part.
for instance, mathematics is a given, how I construct a formula is at question.
hope that helps.
 
Marc

Marc

Fully vaccinated are you?
Leader
Please have Patience

NikkiQSM said:
Does no one have the answer? Or am I asking a very stupid question? ;)
Click to expand...
There aren't any stupid questions. However, one must understand that the Elsmar Cove forum is a volunteer forum where people help each other for *free*. People helping People.

No one should have an expectation of getting an immediate reply/answer to a question which is asked. Sometimes it may take a day or so for a question to be answered. Sometimes questions are answered within minutes. And, unfortunately, some questions never get a reply (usually because none of us knows the answer). But we do try. As always, my Thanks to everyone here who helps.

We appreciate your patience and understanding.
 
Ronen E

Ronen E

Problem Solver
Moderator
NikkiQSM said:
Much help needed my friends...

I have been reading through related threads through-out the Cove regarding the end of 7.5.2.1 - "The organization shall establish documented procedures for the validation of the application of computer software...."

I have read through one thread that says the clause is talking about the computer software used to make the product.

And I have read another that states it is the software installed in the product.

Can someone please just tell me which on it is refering to?

We produce plastic pellets - our extruders use computer software. So I am assuming that that is the software I would validate?

Thanks for the help in advance!
Click to expand...

As far as I understand / am aware, plastic pellets are not medical devices ;). I fail to see the relevance of ISO 13485 to plastic pellets production (regardless of what these pellets are consequently used for), other than a net-promotional value (such as being able to say, for instance, "we make speciality pellets intended for the medical industry, and we even have ISO 13485 certification"). The logic throughout ISO 13485 is based on it being applied to medical devices.
 
N

NikkiQSM

Quite Involved in Discussions
I hear ya... It's just another accomplishment our medical device manufacturers / customers are pushing on us. During the process of transitioning our QMS to 13485 I have already had to exclude much of section 7 (specifically 7.5) due to it being directly related to medical devices... But the customer is always right, right? ;)
 
N

NikkiQSM

Quite Involved in Discussions
Re: Please have Patience

I apologize if it seemed like I was pushing for an answer so quickly. I have only been with the Cove for a couple of months, and I suppose I have been spoiled with receiving such quick replies with my prior posts.

I shall try to practice some patience.

Thanks :)
 
You must log in or register to reply here.
Top Bottom