Guidance on ISO 13485 Section 7.5.2. about Software Validation

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Padams13

Hello,
I work for a company that is ISO 9001:2000 certified and am working on making our QMS compliant with ISO 13485 with the goal of certification. We are pursuing this as a result of pressure from our customer base. In doing a gap analysis one of the major differences between 9001 and 13485 is in the last paragraph of 7.5.2. that states that there shall be documented procedures for the application of computer software. My question/ request is whether anyone can give some guidance on what types of software would be applicable to this requirement? I know things like test software would apply but I want to make sure we don't go overboard with what we identify as needing validation.

Any help would be greatly appreciated...
 

GStough

Leader
Super Moderator
Welcome to the Cove! :bigwave:

One area to look at is whether your IT/IS department writes its own programs (or databases) for capturing/reporting data. This can be anything from incoming materials inspection to final product inspection, as you mentioned testing, or any other activity that has value to your organization.

Our IT department has developed a company-specific software/system that contains all kinds of data from purchasing to final inspections, as well as inventory levels and shipping reports. I'm sure there are many, many other functions of which I'm not aware, but these are a few to give you some ideas of the kinds of programs that would benefit from validation.

I hope this is helpful. :bigwave:
 

Ajit Basrur

Leader
Admin
FDA lists the applicability very vividly in the document, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff", http://www.fda.gov/cdrh/comp/guidance/938.html as -

2.1. APPLICABILITY

This guidance applies to:

1. Software used as a component, part, or accessory of a medical device;
2. Software that is itself a medical device (e.g., blood establishment software);
3. Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and
4. Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history record).

This document is based on generally recognized software validation principles and, therefore, can be applied to any software. For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy. This document does not specifically identify which software is or is not regulated.
 
T

treesei

Last month from an FDA officer who is also the chairman of WHTF I heard that WHTF is working on a software audit guidance. I think it would be interesting to many of us covers if someone can provide some details.
 

Ajit Basrur

Leader
Admin
Last month from an FDA officer who is also the chairman of WHTF I heard that WHTF is working on a software audit guidance. I think it would be interesting to many of us covers if someone can provide some details.

Are you referring to GHTF (Global Harmonisation Task Force) ?
 
Q

Quality Priest

My understanding is that any software used that has the potential to affect
product quality must be validated.

This was my take on software validation for 13485. It is much more basic than the FDA requirements.
We had;
Quality Database - MS Access
SAP (Type) System
Compliance Software system

The validation performed was retrospective (hint) running a paper system along side and then ensuring that each module had captured the data as required.

I did take a look at the FDA requirements and was very glad that the company I was working for at the time was not US or supplying to the US :D
 
P

Padams13

Thanks for all of the input, it has given a good starting point...
 
V

vinh_lex - 2010

2.1. APPLICABILITY

This guidance applies to:

1. Software used as a component, part, or accessory of a medical device;
2. Software that is itself a medical device (e.g., blood establishment software);
3. Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and
4. Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history record).

This document is based on generally recognized software validation principles and, therefore, can be applied to any software. For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy. This document does not specifically identify which software is or is not regulated.



is this to say we have to validate the manufacturing equipment per Process Validation Guidance (IQ, OQ, PQ)... and validate its software per this guidance of FDA as well?
 
V

vinh_lex - 2010

Let me put the question in a clearer context, (and hope this is not a dead thread)

ISO 13485 called for a documented procedure for the validation of computer software, which by FDA guidance include numerical program for manufacturing requirements.

On the other hand, our external auditor requested to apply the IQ, OQ, PQ for process validation.

Then how can we put these 2 requirements together? any constrain keep us from using the process validation result as evidence that all software used in that process has been validated?

Please also note that we're an EMS factory in Vietnam, and not registered to FDA. and we want to keep risk analysis and/or validation protocol/report to the lowest level of complication.

Appreciate if there's any help.
 
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