In the next SOLABS QM Release 10.9.0, there will be two main changes/additional features, that will not affect the current behavior of the system but that will provide additional options to use it at another level.
These two new features are currently in use by some of our clients but, as of release 10.9.0, they will be deployed and made available to ALL SOLABS’s clients.
The new features are the following:
❶ Integration with Questionmark OnDemand for Online Assessments
❷ Deployment of the SOLABS QM Audit Process APP (P0044)
What are these and what are the Benefits?
Integration with Questionmark OnDemand for Online Assessments
In the Training section, when creating a Training Activity, it will now be possible to create a link to an online Assessment (such as a Test or a Quiz). This is possible through our partnership with Questionmark through their system called Questionmark OnDemand. The Questionmark OnDemand service is an online assessment platform providing the ability to author assessments for electronic access and completion.
What does this do?
When a user is assigned a Training Activity that is linked to a Questionmark OnDemand Assessment, the trainee will need to complete the Assessment with a passing score before they are able to record their training. If the passing score is not achieved, the training assignment is considered failed and the Training Activity is reassigned to the trainee to complete again.
These Assessments do not reside in SOLABS but in the Questionmark OnDemand system where they are created by specific ‘super users’ given administrative accounts in that system and trained by Questionmark on how to use the system - possibly your current Training Administrators. After linking the Assessment to a Training Activity and assigning it in SOLABS QM, the trainee will see a link on the Training Activity page called Open Assessment.
Clicking on that link will bring them directly to the linked Assessment where they will see any instructions created by the Training Administrator.
The option to link an Assessment will be available when creating any kind of Training Activity (Classroom, Presentation, Documents, etc.). An Online Assessment can even be created as a stand-alone assignment. Using Assessments provides a way to evaluate trainee comprehension and understanding of the Training Activities you assign.
This feature is much appreciated by clients who are already using it!
Deployment of SOLABS QM Audit Process APP (P0044)
The QM Audit Process APP will now be deployed for every client.
The Audit Process workflow can be used for any kind of audit (internal, external, regulatory, etc.). It allows you to track all audit-related activities from Audit Planning (purpose, scope, audit team, audit dates, etc.), to Audit Preparation (which audit activities are required by whom, etc.), to monitoring of the actual Audit Activities (daily summaries, preliminary findings, exit meeting, etc.), to Preparation and Issuance of Audit Report, and finally to managing the Audit Report Responses, assignment, and Completion of Commitments (CAPAs, etc.) and Audit Closure.
As with all SOLABS QM APPS, you have the ability to create/assign Secondary Tasks, link Related Documents, or link Related Processes. You also have access to related reports in the SOLABS QM Reports Portal.
This is a useful process also much appreciated by clients who are currently using it.
Other small changes coming with Version 10.9.0:
- Validation of whether or not a file is attached to the metadata when creating or revising a document. If the new option ‘There is no file for this document' is not selected, an alert will remind you that you haven't uploaded your file.
- Some new notifications
- Some bug fixes for the core software and the Document Control Process (P0007)
The Release Notes can be found at the bottom of this page.
Documentation related to the qualification exercise of QM10.9 release can be found in the Room in the Public Folder. Find this information in the following folders:
10.9.0 (Core Software)
Document Control Process V3.2.0
Audit Process V3.1.0
There are three (3) folders in the Core Software release folder:
- Operational Qualification and Executed Test Scripts: contains the Operational Qualification Protocol, the executed tests, and the Operational Qualification Summary Report - This documentation is provided once executed.
- Global Validation Documentation: contains all the supporting documentation for the core software such as Functional Specifications, Validation Plan and Index, Change List, Software and Design Specification, Traceability Matrix, etc…. Most of this documentation is provided at the beginning of the release or once completed. Can be updated during the qualification exercise.
- Installation – Updates (SOLABS Qualification Environments): contains the executed procedures for the installation, updates activities for the qualification instances used for performing the qualification exercises - This documentation concerns the qualification instances only and each client will have their own installation/update executed procedures when installation/update is performed in their environments.
There are essentially two (2) folders in the Processes folders:
- Installation and Operational Qualification and Executed Test Scripts: contains the Qualification Protocol, the executed tests, the Qualification Summary Report, and the installation/updated procedures – This documentation is provided once executed. The documentation for the installation/update of the process concerns only the ones installed or updated in the qualification instances and each client will have their own installation/update executed procedures when installation/update is performed in their environments.
- Global Validation Documentation: contains all the supporting documentation for the process such as the Process User and Functional Specifications and the Traceability Matrix. - Most of this documentation is provided at the beginning of the release or once completed. Can be updated during the qualification exercise.