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Validation of IT Service Management System

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Guest user Created:   Apr 11, 2019 Last commented:   Apr 11, 2019

Validation of IT Service Management System

I am IT Manager in a medical device company.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Verlene Law Apr 11, 2019
We are currently implementing a new Service Management System, i.e. the system to handle tickets from users when having Incidents or service requests regarding their use of IT.
Off course we have many validated IT systemes - and tickets regarding these systems are also handled in this new SMS.
I have now gotten into discussion around validation of this new Service Management System.
In my perception the tickets are Quality Records - and a system handling quality records would need validation.
However I cannot not find a direct link anywhere in ISO13485:2016 - or elsewhere describing this scenario and the requirement to validate.
Am i wrong in my conclusion ?

Answer:

Indeed, you are right that this is a quality record system, therefore, it should be validated. You can refer to clause 4.1.6 and 7.5.4 Servicing activities in ISO 13485 for more information.

This material will help you regarding the validation of your system:

Procedure for Documentation and Validation of Computer Softwar e
https://advisera.com/13485academy/documentation/procedure-for-validation-of-computer-software-iso-13485-2016/
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Apr 11, 2019

Apr 11, 2019

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