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SimplerQMS 3.1.5 Release Notes (Patch)

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Effective Date: 2024-03-15

Release Date: 2024-03-29

Improvements

ID: SQ-665

Summary: Create Subchapter for Standard Chapters

Details: Users now have the capability to create nested standard structures through the introduction of Subchapters to Standard Chapters and definition of a Main Level on the Standards. This feature enables a more granular and organized approach to document management, facilitating easier overview and navigation within the system. A new set of views has been introduced and will be expanded upon in future releases. If there is any urgent need for new views for this feature, please reach out to support@simplerqms.com.

ID: SQ-679

Summary: IND structure introduced as Standards and Standard Chapters

Details: Introducing the IND (Investigational New Drug) structure within the system. Users can now tag documents using the Standard Chapter field, enhancing organization and accessibility within the IND framework. If this list is not relevant to the organization, the values can be disabled and made Not Current. This removes them from being selectable on the Standard Chapter field.

ID: SQ-680

Summary: eTMF structure introduced as Standards and Standard Chapters

Details: Introducing the eTMF (electronic Trial Master File) structure within the system. Users can now tag documents using the Standard Chapter field, enhancing organization and accessibility within the eTMF framework. If this list is not relevant to the organization, the values can be disabled and made Not Current. This removes them from being selectable on the Standard Chapter field.

ID: SQ-662

Summary: Action – Assignee comments are deleted in draft

Details: The Assignee Comment has been renamed to Resolution for clarity. Any previously filled Assignee Comments for this reason will remain filled. This change ensures a better understanding of the action’s resolution status. This field will remain filled out, even if the Action is rejected. Instead, A new field, Reason for Rejection, has been introduced. In the event of Action rejection, the Reason for Rejection field is mandatory for the assignee to fill. This value is emptied when the Action is in the Draft state after rejection.

ID: SQ-660

Summary: Document collection – Prevent the choice of wrong class

Details: When attempting to create a Document Collection object, the system provides specific guidance through new error cases. These improvements aim to provide clearer guidance and reduce potential errors during the object creation process. When creating a new Document Collection from the Create button, if a user selects a class other than ‘Document Collection,’ an error message prompts them to choose the correct class. If a user selects ‘Document’ as the object from the Create button, but chooses ‘Document Collection’ as the class, they will receive a clear error warning.

ID: SQ-635

Summary: New Admin Log field for SimplerQMS Administrator user

Details: Introduced a new field in the System information section to facilitate future updates in SimplerQMS via deployment. This new field serves as a proactive measure to initiate metadata card updates seamlessly in any future updates of the system.

ID: SQ-668

Summary: Change of License names

Details: We’ve refined the terminology for licensing options to enhance clarity and understanding. The License Dashboard has been updated to reflect these changes. The term “Concurrent License” has been updated to “Shared License,” indicating that multiple users can share access under this license type. “Named License” has been renamed as “Single User License,” reflecting that it is a license for individual use.

ID: SQ-675

Summary: Printed By user delegate on Controlled Print Tracking Items

Details: To prevent recall notifications from being overlooked when an employee leaves, their delegate user will now be automatically added to the generated Print Tracking Items for which they were responsible.

ID: SQ-628, SQ-651, SQ-659

Summary: Optimized performance by removing unused settings from the codebase

Details: There are no changes to the user interface, these enhancements aim to make the system more reliable and robust and increase performance.

ID: SQ-666

Summary: New Compliance Kit version

Details: There are no changes to the user interface, these enhancements aim to make the system more reliable and robust and increase performance.

ID: SQ-670

Summary: New Property Calculator Version

Details: There are no changes to the user interface, these enhancements aim to make the system more reliable and robust and increase performance.

Bug Fixes

ID: SQ-656

Summary: Periodic Document Review permission recalculation

Details: The permission recalculation is limited to the New state. This change allows users to manually change the Responsible Person field on Periodic Document Reviews without the setting reverting to the original responsible person of the source document.

ID: SQ-669

Summary: Block rollback of attachments to initial version

Details: To prevent the regeneration of document numbers, the ability to roll back to the initial version of a document attachment has been blocked. This measure ensures that document numbers remain consistent and avoids potential confusion or duplication caused by rolling back to the first object version in history.

Key improvements released by M-Files

Description: Metadata Field Codes update automatically in PowerPoint files

Standard Feature: Previously Field Codes in PowerPoint document did not update until the document’s release. Field codes now update automatically.

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