EQMS Validation

[yodon]

So, if I understood correct its like one size fits all method of validating.

Ooh, no! You should absolutely plan and scale the efforts based on risk (or 'rick' if you will ;-) )

 

[LUFAN]

Curious to know what the other options are if we want to update our validation procedure to remove GAMP Methodology

ISO 80002 was released for this very reason. It's titled validation of software for medical device quality systems

ISO/TR 80002-2:2017 applies to

- software used in the quality management system,

- software used in production and service provision, and

- software used for the monitoring and measurement of requirements.

It does not apply to

- software used as a component, part or accessory of a medical device, or

- software that is itself a medical device.

 

[Tidge]

GAMP 5 was more concerned with custom/OTS/configured software; risk (in the patient / user sense) barely contributed to the actions.

 

[srkn14]

GAMP 5 was more concerned with custom/OTS/configured software; risk (in the patient / user sense) barely contributed to the actions.

agreed, GAMP covers the complexity level of a system. I noticed some companies are combining the Impact of the systems with GAMP Categorization to determine the extent of validation. I am looking for any guidance that I can follow to develop purely a risk-based validation and avoid GAMP Methodology.

 

[srkn14]

ISO 80002 was released for this very reason. It's titled validation of software for medical device quality systems

would you mind sharing a link to this reference please?

 

[yodon]

would you mind sharing a link to this reference please?

You have to purchase it; e.g., from the ANSI Webstore. They are apparently pretty proud of it, at > $500!

 

[Tidge]

I am looking for any guidance that I can follow to develop purely a risk-based validation and avoid GAMP Methodology.

Here is some guidance: If the software isn't referenced in the DHF (including the risk management files) then the company doesn't believe it serves any role in contributing/controlling product risk.

For compliance risk, you would have to consult appropriate regulations (e.g. for Electronic Signatures, Complaint Handling) to find requirements that the software will have to satisfy.

For business risk, talk to executive management and find out what they want tested.

 

[LUFAN]

would you mind sharing a link to this reference please?

You just need Part 2: ISO/TR 80002-2:2017
Sometimes you can buy standards from some Eastern European standards store for much less, but this particular one doesn't look to have been issued by anyone but ISO directly.

You have to purchase it; e.g., from the ANSI Webstore. They are apparently pretty proud of it, at > $500!

That link also includes ISO 14971 and the wrong part of 80002. Part 2 is for QMS software validation, part 1 is for risk management within it.
ANSI correct link: https://webstore.ansi.org/standards/iso/isotr800022017

 

[Jean_B]

Recently heard about South Africa's standards store:
https://store.sabs.co.za/satr-80002-2-ed-1-00-2144082.html shows 1120,10 Rand which google today sets at 60ish US Dollar.
Up till now I've bought at EVS where the EN editions are markedly cheaper, but pure ISO isn't. Haven't had a reason to buy at the above website yet, so let us know how it goes (if you do).

 

[LUFAN]

Recently heard about South Africa's standards store:
https://store.sabs.co.za/satr-80002-2-ed-1-00-2144082.html shows 1120,10 Rand which google today sets at 60ish US Dollar.
Up till now I've bought at EVS where the EN editions are markedly cheaper, but pure ISO isn't. Haven't had a reason to buy at the above website yet, so let us know how it goes (if you do).

good to know thanks. I've used EVS mostly as well.