IT validation for a paper based MD repair company QMS

MDRepair Canada

Starting to get Involved
#1
Hello,
We are a small MD repair company with a paper based QMS. I wondered if we were concerned by the requirements related to IT validation. The only software we have are related to inventory or operations (from repair order to delivery to customer). Do we need to validate them and do we need to write a procedure on it. I wondered if we could use the risk assessment to justify that these software have a very low impact on product conformity.
Thank you in advance for your help!
Best regards,
 
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LukasLosigkeit

Starting to get Involved
#2
Hello,
We are a small MD repair company with a paper based QMS. I wondered if we were concerned by the requirements related to IT validation. The only software we have are related to inventory or operations (from repair order to delivery to customer). Do we need to validate them and do we need to write a procedure on it. I wondered if we could use the risk assessment to justify that these software have a very low impact on product conformity.
Thank you in advance for your help!
Best regards,
ISO 13485:2016, 4.1.6 says, you shall document procedures for the validation of the application of computer software used in the QM system. And such software shall be validated prior to use.

To be fully compliant, you need to validate software within your QMS.

Note: But not all software used in your company is software that you use within your QMS.

I guess that the software described by you is part of the QMS, as you said it has little impact on product conformity. Therefore, validation is required (and a procedure). But considering the risk basked approach, your validation does not need to be as extensive as for a high risk software.
 

yodon

Staff member
Super Moderator
#3
Good feedback by @LukasLosigkeit. You'll want to have documented rationale for the approach you take. What can happen if the software fails? Are you maintaining service/repair records in the software? If so, that may kick things up a notch since those are required records and need to be analyzed.
 

MDRepair Canada

Starting to get Involved
#4
Thank you for your answer! The only risk I see : not using the proper part to repair the MD because of failure of the software.
But some controls are done by the operator to check that it is the right part. If i write a procedure explaining how we mitigate any risk of failure of the software, is it ok? How is it possible to validate a software we have been using for years ?
 

LukasLosigkeit

Starting to get Involved
#5
Thank you for your answer! The only risk I see : not using the proper part to repair the MD because of failure of the software.
But some controls are done by the operator to check that it is the right part. If i write a procedure explaining how we mitigate any risk of failure of the software, is it ok? How is it possible to validate a software we have been using for years ?
The easiest way to validate the software is the black box approach.

What goes in that box? What is expeted to come out as an answer?
Create test cases where you test the things you do with the software in routine use. Test these functions.
Consider also min/max values.
e.g. you can enter at least 0 and max 255 pieces per item. You should definitely test such values.

Do you know how to validate in general / how to perform software validation?
 

yodon

Staff member
Super Moderator
#6
How is it possible to validate a software we have been using for years ?
Let me bookend the response from @LukasLosigkeit. First establish the requirements for what your use of the software is. Then do the testing described. Since you've been using this for years, the effort is considered a "retrospective validation" which means that you have to consider the lack of validation for everything in the past. This is mostly only an issue if any issues are found in testing. If you find issues, you need to consider what that meant to past use and whether there was any impact on product or regulatory compliance from using the software with the issue.

Since I presume you are operating under 13485 and you were using non-validated software, it's probably best to run this under a CAPA since it sounds like you don't have the process in place at all.

Bear in mind that validation is not intended to be a one-time effort. You have to consider whether changes warrant re-validation. Changes are not limited to the software itself. You can have changes in underlying software (e.g., database engines), changes to use profile (new use scenarios, expanded number of users), changes to the OS under which the software runs, etc. This is why I suggest running under a CAPA to flesh out the complete process and not just test.
 
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