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Validating Conformio software

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Guest user Created:   Sep 18, 2019 Last commented:   Sep 18, 2019

Validating Conformio software

Hello, I have a question whether Conformio software has to be validated as per ISO 13485:2016 requirements, Clauses 4.1.6 and 7.5.6, and if it has to be validated what is the best way to do it?
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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.

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Kristina Zvonar Brkić Sep 18, 2019

Yes, it is necessary to validate Conformio software. Conformio is verified by our internal testing. The simplest way for a client to validate Conformio is to create a list of the functionality and behaviors it expects from Conformio and check them in software. Of course, each client will have their own specific requirements. Here are some specific points that can be covered:

Data integrity - can the data be changed inadvertently? Or if inadvertent changes occur, are they flagged &/or detectable?
Document metadata has a full history in Conformio, and document data changes are tracked by Word’s Track changes feature. Each separately saved version of the document can be accessed, there is full history and older versions are kept. The user can choose to overwrite the existing version, though (this is a must-have requirement from some other customers).
Files can be locked from later changes (status Approved), and for Word documents, Track Changes can be turned on (but can be turned off by the user). Currently, track changes can be turned off and can be 'accepted' by users, without a record of what changed.
Access to data/files


There are several levels of access to Conformio:
Accessing the Conformio platform: through username and password
Accessing the specific project: the account administrator defines the project access through Project Settings or through the Users module; also, the Project Manager on the project can allow access to a user through Project Settings
Accessing folders/files: the folder Owner, Admin or Project manager can grant access to a user.
Audit trails
Changes in documents metadata are shown in the Notification bar and in the Overview tab.
Changes on tasks (changing the Assignee, due dates, etc) from projects and Compliance modules are shown in the Overview tab...

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Sep 18, 2019

Sep 18, 2019

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