Software Validation Certificate (ISO 13485:2016)

[talal]

I'm looking for any format for software validation certificate. Which aspects of the report should be made part of the certificate?

 

[Marcelo]

What do you mean by software validation certificate? ISO 13485 require software validation, not a certification, and this is not a certifiable activity.

 

[JoshuaFroud]

Who has asked for a certificate is this a customer or regulatory request?

 

[talal]

We purchased some equipment having software. The manufacturer of the equipment did not provide any document related to software validation. In the audit, we were asked to get the documents for software validation. Hope I convey my point.

 

[pbojsen]

The manufacturer likely doesn't have this documentation available to customers. You can call and ask for it, but they either won't supply it, or they will charge you for it. Regardless, you have to validate it for it's intended purpose for ISO 13485. Validation would include equipment IQ/OQ/PQ.

Validation of equipment run by software usually requires at least a HACCP analysis, with testing of the critical control point, including boundaries. This would be included in your OQ/PQ.

 

[talal]

The manufacturer likely doesn't have this documentation available to customers. You can call and ask for it, but they either won't supply it, or they will charge you for it. Regardless, you have to validate it for it's intended purpose for ISO 13485. Validation would include equipment IQ/OQ/PQ.

Validation of equipment run by software usually requires at least a HACCP analysis, with testing of the critical control point, including boundaries. This would be included in your OQ/PQ.

We have conducted equipment/process validation and asked the equipment manufacturer for software validation reports, but they were unaware of it. Could you explain the steps for carrying out software validation if we have to perform it?

 

[SKM.Sunil]

We have conducted equipment/process validation and asked the equipment manufacturer for software validation reports, but they were unaware of it. Could you explain the steps for carrying out software validation if we have to perform it?

The equipment manufacturer must not have validation as per ISO13485, but a kind of validation should be there with them, only need to make ISO13485 compliance. without validating a software how can a manufacturer market its product and without doing validation of the purpose of need how I can buy it.

moreover, you can do validation internally or externally. download this guideline "General Principles of Software Validation; Final Guidance for Industry and FDA Staff " (just google it), this might help you in getting more idea.

 

[talal]

The equipment manufacturer must not have validation as per ISO13485, but a kind of validation should be there with them, only need to make ISO13485 compliance. without validating a software how can a manufacturer market its product and without doing validation of the purpose of need how I can buy it.

moreover, you can do validation internally or externally. download this guideline "General Principles of Software Validation; Final Guidance for Industry and FDA Staff " (just google it), this might help you in getting more idea.

Thanks for the reference.

All of the equipment from that manufacturer are CE marked. Isn't software validation a requirement for CE marking of equipment?

 

[SKM.Sunil]

Thanks for the reference.

All of the equipment from that manufacturer are CE marked. Isn't software validation a requirement for CE marking of equipment?

1. Does the CE mark contain NB number/ does it belongs to the medium or high-risk category?
2. And moreover, in MDD it was optional for software to be validated according to any standard.

With changed MDR and IVDR, it is now mandatory to validate any software associated with the Medical Devices/ In-vitro Devices operations and now it is also mandatory in the new submission for CE.

Periodic validation of software also required as like a clinical evaluation of MDs

 

[Ajit Basrur]

Thanks for the reference.

All of the equipment from that manufacturer are CE marked. Isn't software validation a requirement for CE marking of equipment?

To start with, can I check if you have a procedure on software validation?

The level of software validation depends if it is Commercially Off The Shelf (COTS), Modified Off The Shelf (MOTS; meaning you purchase a COTS but customize/configure certain elements); or if it is Custom made for your organization. In the hierarchy of software validation, the COTS is minimal while Custom is maximum. Typically, when you carry out the software validation in your facility, you reference/attach/build upon certain supplier requirements.

Hope that helps!