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.

The post SimplerQMS 3.1.5 Release Notes (Patch) appeared first on SimplerQMS.

Effective Date: 2024-02-20

Improvements

ID: SQ-284

Summary: Prevent CR Controlled Items from being edited when CR awaits approval

Details: When a Change Request connected to templates or quality documents enters the “Awaits Approval Signature(s)” state, rejecting the template or quality document is no longer possible. This ensures that a CR isn’t released with pending objects.

ID: SQ-368

Summary: New views for Parent and Child Projects and Archives

Details: In Main Views > Projects two new views are available for better folder structures: Parent Project > Child Project > Archive and Project > Parent Archive > Child Archive

Bug Fixes

ID: SQ-441

Summary: Action does not calculate Activation Date if Grace period unit is Weeks

Details: The option for “weeks” has been removed due to the absence of a calculation rule in the configuration. For weeks, express as “7 (or more) Days” instead.

ID: SQ-445

Summary: Prevention rule for Document Type change when routing for approval

Details: Previously, under certain conditions, users could alter the Document Type while simultaneously routing a document for approval. This caused a discrepancy between the Document Type in the working copy and the released version. This issue has been resolved, preventing such inconsistencies from occurring.

ID: SQ-637

Summary: Attachment overlay is only applied on page 1

Details: Document attachment overlay is now applied to all pages. Any attachment where the issue can be observed can be routed for update and when sending for filing the overlay will be reapplied.

ID: SQ-645

Summary: Actions related to Change / CAPA cannot be created by user not in the Change Manager / CAPA Handler User Group

Details: With the exception of users with “Read and Sign” permissions, any user can now initiate actions related to CAPA or Change Requests.

ID: SQ-646

Summary: CAPA – close (final) review immediately has no electronic signature

Details: Electronic signature requirement is fixed and this action will require a signature.

Key improvements released by M-Files

Description: M-Files properties in Excel include the property name for easy identification

Standard Feature: M-Files properties now include the property name within the comment field of Excel Name Manager, making it easier to identify different properties in Excel documents.

Description: “Input string was not in a correct format” error in the classic M-Files Web during object creation

Standard Feature: Creating a new object through metadata triggered the display of the error message “Input string was not in a correct format.” in the M-Files Classic Web. The error has been resolved.

The post SimplerQMS 3.1.4 Release Notes (Patch) appeared first on SimplerQMS.

Effective Date: 2024-01-22

Improvements

ID: SQ-405; SQ-481; SQ-614; SQ-74

Summary: 15 new Custom Fields

Details: 15 new custom fields can now be added to metadata cards. Metadata Administrators can configure five value list fields, four text fields, four number fields, and two date fields, tailoring information to specific classes, such as Recorded Issues, Suppliers, Products etc. This feature promotes flexibility, consistency, and precision in capturing diverse data types. See video below.

ID: SQ-621

Summary: Performance Improvements

Details: Through disabling of additional processing steps, speed in signature processing is improved. This optimization is a part of our continuous effort to ensure a more efficient and faster overall performance.

ID: SQ-617

Summary: Allow the change of Initial Reviewer field in more states

Details: The states New Draft and Awaits Update now allow the Responsible Person to change the Initial Reviewer(s) field on Recorded Issue Documents.

Bug Fixes

ID: SQ-622

Summary: Document stuck in Prepare New Version and All Approvals Captured

Details: Enhanced the robustness of 18 State Transition pairs, preventing scenarios where documents get stuck in the workflow, requiring admin intervention. This ensures that actions are scheduled and processed systematically, eliminating issues from the previous version where simultaneous actions on documents could lead to object locking and incomplete processing.

ID: SQ-611

Summary: QA Responsible and HR Permissions on Periodic Tasks

Details: The Quality Assurance Responsible and Human Resources user groups are now permitted to Reassign to a New Responsible Person on Periodic Tasks.

ID: SQ-598

Summary: Better placement of Effective Date field on Audit Plan Documents

Details: Aligned the metadata card location of the Effective Date field on Audit Plan Documents with other document classes.

ID: SQ-615

Summary: 3 days or less to overdue notification does not have a reference to the related object

Details: Email notification message is improved with a reference link to the object the email is about.

ID: SQ-616

Summary: Mandatory for All column in the Learning Rules view

Details: The column, containing information unrelated to the learning rules, has been removed to enhance overall clarity.

ID: SQ-623

Summary: Unused property cleanup – License Type

Details: License Type field removed as it is not showing data. Information about assigned licenses can be accessed through the License Dashboard.

ID: SQ-627

Summary: Cleaned up Document Manager assignment on Periodic Doc Review

Details: Document Managers are no longer assigned to Periodic Document Reviews.

ID: SQ-629

Summary: Better placement of Completed on Time field on Reminder Tasks

Details: Aligned the metadata card location of the Completed on Time field on Reminder Tasks with other task classes.

ID: SQ-642

Summary: CAPA review and approval and Audit approval not reset when rejected / routed back to draft

Details: Missing settings were corrected to ensure Reviewers and Approvers are corrected when the CAPA document is rejected or sent back to draft and when Audits are rejected or reopened to add more findings.

Key improvements released by M-Files

Description: New UI improvements

Standard Feature: Experience a more modern look with improved interface design. Enhanced visual aesthetics for a better and more contemporary user experience.

Description: Automatic Log-out in Classic Web

Standard Feature: Now, classic web users can benefit from automatic log-out settings, similarly to all windows desktop users. By setting a logout timer, all users will be logged out after the specified idle time. This is especially useful for customers with concurrent licenses. To enable this feature, please reach out to support@simplerqms.com for assistance.

Description: Share and PDF options

Standard Feature: Enhanced sharing options in M-Files Desktop for a clearer experience. Infrequently used features have been removed. Additionally, PDF options are now located in a dedicated “Save as PDF” section within the context menu, ensuring a more organized and user-friendly navigation.

Custom Fields

Custom Fields provide users with a powerful tool to tailor and organize data according to specific needs. It provides a high degree of flexibility in defining information captured on metadata cards.

The Metadata Admin can customize the settings for the following field types:

Value Lists (Sections 1-5):

• Add up to 5 custom value list fields to metadata cards
• The lists can either be multi- or single select lists
• The same list can be enabled and used across one or more classes

Number Fields (Sections 6-9):

• The custom number fields only allow for numeric input including decimals

Date Fields (Sections 10-11):

• Add custom date fields to allow for input of any dates while ensuring the correct date format

Text Fields (Sections 12-15):

• The text fields can accommodate long text or short text.
• Long text, can contain multi-lines up to 10,000 characters and short text can contain one line up to 100 characters

All fields can be set to be mandatory or optional.

Once custom fields are configured and activated, they integrate into the standard metadata card in a section called “Custom Fields”, maintaining a familiar user experience. These fields can be used in Office documents in the same way as the current fields are used.

This feature is optional and will not impact any metadata cards if not enabled.

The new fields have no impact on workflow processing or permissions; these remain unchanged.

The post SimplerQMS 3.1.3 Release Notes (Patch) appeared first on SimplerQMS.

Effective Date: 2023-11-21

ID: SQ-491

Description: Product cannot be related to CR but it is mandatory for adding relation to product lot number.

Improvement: Product Items can be related to Change Requests. When a product item is named in the Relation field, it cannot be associated with the Change Request as a Controlled Item and vice versa.

ID: SQ-566

Description: Allow Recorded Issues to be updated in all states.

Improvement: Recorded Issue Documents can now be updated to a new major version in any state.

ID: SQ-585

Description: Actions, CAPA Assessment, Doc Review: Completed in time is not set.

Improvement: CAPA Effectiveness Assessments, Periodic Document Reviews, Actions, and Reminder Tasks display if the assignment has been completed on time.

ID: SQ-588

Description: Training: Simplify Read & Understood process.

Improvement: Removal of an additional state transition to improve performance on training record completion.

ID: SQ-584

Description: Copy Actions.

Improvement: Option available to Create Copy for Actions.

ID: SQ-597

Description: Prevent rollback between major versions.

Improvement: A recent discovery showed that some states allowed to roll back to previous major version in the document history. Preventive measures have been implemented to restrict this option.

ID: SQ-531

Description: Both Department and Departments is shown in the expanded view of a Person.

Improvement: Department list is kept.

ID: SQ-564

Description: Prints should only be recalled when new version of doc is effective, not for learning.

Improvement: Recall will only be initiated once the effective date of a document is reached, and not in the For Learning state. The recall deadline is 2 business days after Effective Date.

ID: SQ-568

Description: Both Actions and Related Actions are visible properties under the CAPA expanded view.

Improvement: Actions property is kept.

ID: SQ-569

Description: Content Views by person filters out former employees.

Improvement: Masterdata Views > Content Views > Content by Person (Including Not Current) shows content related to former employees for easy reassignment.

ID: SQ-574

Description: Training record: Date completed not set correctly.

Improvement: Date is calculated correctly based on new settings.

ID: SQ-576

Description: Copy site should not be allowed.

Improvement: It is no longer possible to use the Copy command on Site objects.

ID: SQ-579

Description: Recorded Issue: Initial reviewer missing on template for recorded issues.

Improvement: Initial Reviewer is now part of the Target Class Recorded Issue Document Templates for prefilling and field code use.

ID: SQ-581

Description: Modification of initial reviewers not possible.

Improvement: In Modify Initial Reviewer state of Recorded Issues the Initial Reviewer could not be modified.

ID: SQ-582

Description: Update view of all training groups.

Improvement: 3. Masterdata > Persons > Persons – by Training Group includes the list of all training groups, even those that are not currently assigned. This provides a full overview of the training groups created within the vault.

ID: SQ-589

Description: Action Responsible Person gets defaulted to Initiator account.

Improvement: Actions no longer revert back to the Initiator account on the Responsible Person list.

The post SimplerQMS 3.1.2 Release Notes (Patch) appeared first on SimplerQMS.

Effective Date: 2023-10-26

ID: SQ-524

Description: Affected Processes added on Recorded Issues + CAPA Metadata under relations.

Improvement: CAPAs and Recorded issues can be linked to Processes via the Affected Processes field.

ID: SQ-552

Description: Special characters are not picked up on the signature page.

Improvement: Due to the font (Helvetica) used on the Electronic Signature page added to documents, foreign characters did not pick up on the signature page. The font has been changed to Arial and is now capturing the correct characters. This change will only be visible on documents approved after the update to 3.1.1.

ID: SQ-550

Description: Expand the Visual Workflows to all classes.

Improvement: Visual workflows are configured for all existing workflows to provide better visual support when navigating workflows.

ID: SQ-549

Description: Create optimized views for users who only have Read Only permissions.

Improvement: A new subset of views created for Released documents organized by different metadata – found under 2. Main Views > 1.1 All Released.

ID: SQ-557

Description: New view for File class.

Improvement: A new subset of views created for the File class organized by different metadata – found under 2. Main Views > 1.2 All Files.

ID: SQ-547

Description: Add columns and a “none” folder to all Person views in Masterdata views.

Improvement: More relevant information is shown in Person views including delegation of permissions, state, and access. Added grouping in By Training Group and By Department for users without relevant metadata – will show as No Training Group and No Department.

ID: SQ-545

Description: Human Resources should have the option to click on Reassign to New RP / Author.

Improvement: Since Human Resources users can complete the delegation of permissions to and from users, they are given permission to the state transition option “Reassign to New Author / RP” on all document classes, templates, actions, tasks, suppliers, and equipment so after delegation, they can trigger reassignment.

ID: SQ-541

Description: Improve the email storage experience on the metadata of Files.

Improvement: Properties for Person(s) and Email From which are automatically captured if relevant data is available in the vault are organized under relations.

ID: SQ-540; SQ-508

Description: Create a view that excludes “not required” training records.

Improvement: A new subset of views created for the Training Records class organized by different metadata – found under 2. Main Views > 11. Training > 1.5.1 Detailed TR (Required) and renaming of view 1.5 Detailed TR for the shorter trail.

ID: SQ-525

Description: Allow all users to see the license dashboard.

Improvement: All users have access to 3. Masterdata > License dashboard for viewing users who are logged in. Force Log Out can be requested from Metadata Admins of the system. You can learn more about the license dashboard here.

ID: SQ-487

Description: Improve the error message “You cannot route a document that is not controlled by a CR…”.

Improvement: For Quality Documents, Templates, and Recorded Issues the error for the message is improved for clarity.

ID: SQ-554

Description: Customer audit views are missing.

Improvement: Added 5. Customer Audit view in 2. Main Views > 2. Audits and included Customer Audit-related documents in 7. Documents Related to Audit.

ID: SQ-544

Description: Remove documents automatically from CR scope if they are set to Not Current – Archive.

Improvement: CR can progress with attached templates and Documents that have been set to Not Current under the execution state.

ID: SQ-543

Description: Complaint template – complaint receiving date not available.

Improvement: Added Complaint Receiving Date to template metadata card for capturing field code inside the template on Target Class Complaint templates.

ID: SQ-533

Description: 3 days or less to overdue Notification.

Improvement: Notification is triggered when objects are reaching 3 Days or Less to Overdue state for the assigned user.

ID: SQ-575

Description: Completed date on training records.

Improvement: There is a risk that the completed date on training records is incorrectly updated showing a date that is not the date when the record was completed. Immediate action here is to hide the property to avoid the risk of showing incorrect dates. A later correction is planned to solve the issue and correct the dates that are incorrect (SQ-574).

The post SimplerQMS 3.1.1 Release Notes (Patch) appeared first on SimplerQMS.

Effective Date: 2023-10-04

1. Introduction

1.1. Purpose of the Document

This document describes the differences between SimplerQMS 3.0 and SimplerQMS 3.1. It serves as a comprehensive reference to help users understand the changes and improvements introduced in the latest software update.

1.2. Objectives for SimplerQMS 3.1 based on customer feedback

SimplerQMS 3.1 is largely shaped by the invaluable feedback from our users. We’ve listened and acted upon your input to make meaningful changes. Reference numbers (SQ numbers) are included to ensure transparency and keep our users informed about how their feedback has directly influenced the enhancements and updates in this release.

The changes are divided into major and minor updates of existing functionality from SimplerQMS 3.1.

There are no prerequisites in SimplerQMS 3.1 to be met or managed by customers, prior to roll-out of SimplerQMS 3.1.

2. Summary of 3.1 release

3. Feature Deep Dive

3.1. Non-Quality Files – File Class

Introducing Files, that offer a versatile and streamlined approach, suitable for various document types that are not considered a quality record such as sales documents, financial reports, research notes, emails, and more.

You can simply drag and drop files for quick storage with a minimum requirement of added metadata.  Alternatively, you can make use of the structured guidance of templates to easily draft documents, ensuring that every piece of documentation within your organization starts from a quality-approved foundation.

With optional metadata, you can maintain the flexibility to organize files within your existing view structures. Additionally, you have the option to add relations, ensuring that you can track and connect files as needed to meet your specific organizational requirements.

Editable and deletable toggles grant you the freedom to decide whether only the responsible person can delete or an added author can edit the document or if everyone who has access can do it. Access to the files is governed by the standard permission settings defined by the site in addition to project permissions and classified document types. Hence, access permission follows the same principles as for Quality Documents.

Deleted Files can be restored for 90 days when moved to delete state. After 90 days the files are removed from any search or view but any deleted file can be recovered by SimplerQMS A/S support.

As opposed to the Uncontrolled Attachment, where a unique ID is assigned, the document type becomes a part of the title and the attachment turns into a PDF automatically, File titles will only have the short title and no document number or document type added to it. The file format is also kept as the original filed record without PDF conversion per overview table below.

The File class expands capabilities in SimplerQMS by adding a document management solution on top of the management of quality documents and records. The chart below outlines some key differences between the main document management classes.

For more details, please read the work instruction on our knowledge base or write to support@simplerqms.com to get guidance on how to get started.

3.2. Visual Workflows

One of the standout features of this update is the ability to view a graphical representation of your workflow. Instead of sifting through complex lists or trying to decipher textual descriptions, you can now see your workflow laid out in a clear and visual format. This not only makes your processes more accessible but also enhances your overall comprehension of how they work.

With this feature, you can easily identify the next and previous steps within your workflow. This simplifies decision-making and allows you to anticipate what actions are needed to keep your processes running smoothly. It’s like having a roadmap right at your fingertips.

You can access additional information through links to the knowledge base. This means that if you ever need more details or context about a particular step or aspect of your workflow, it’s just a click away, promoting informed decision-making.

This feature is currently only available on the Windows Client.

3.3. Home Dashboard

A significant upgrade to the Simpler QMS start screen, designed to enhance your user experience and provide valuable insights right at your fingertips. Our revamped start screen now features a personalized dashboard that puts essential metrics front and center, making it easier than ever for you to stay on top of your tasks and responsibilities.

You don’t need to navigate through layers of menus or sift through lengthy lists. A simple click on any tile takes you directly to a corresponding view, so you can address pending items with ease. It’s all about making your workflow smoother and more efficient.

With real-time updates, you can see the latest assignments that require your attention. Your dashboard keeps you in the loop, allowing you to respond promptly to new tasks and responsibilities as they arise.

This feature is currently only available on the Windows Client.

4. Materials

As part of our ongoing commitment to deliver improvements, we have developed updated versions of relevant procedures and templates that can be integrated into your QMS following the latest release. Our aim is to ensure that these resources remain current and aligned with the most recent advancements.

• Download the latest version of our Document Control SOP containing information on the new File class.
• Download the updated Access Request Template with improvements considering the new permission delegation options.

The post SimplerQMS 3.1 Release Notes (Major Release) appeared first on SimplerQMS.

Effective Date: 2023-08-24

ID: SQ-68

Description: Search Engine changed from dtSearch to SmartSearch.

Improvement: A more powerful search engine, which can handle more objects. Enabling “Smart Search Facets” provides better filtering for search results.

ID: SQ-496

Description: The Property “Date Approved Formatted” hasn’t been processed in certain workflow states for Documents. This led to an empty value after PDF renditioning.

Improvement: Bug fixed.

ID: SQ-497

Description: Compliance Kit version updated. (v23.6.1132.4)

Improvement: Improve System Stability. No changes to the user interface.

The post SimplerQMS 3.0.6 Release Notes (Patch) appeared first on SimplerQMS.

Effective Date: 2023-08-03

ID: SQ-484

Description: Working copies of Quality Documents in the state “Released”, have been visible to employees with “Access Rights to Released Documents”.

Improvement: Released working copies are now only visible to Employees with “Access Rights to Working Copy Documents”.

The post SimplerQMS 3.0.5 Release Notes (Patch) appeared first on SimplerQMS.

Effective Date: 2023-07-17

ID: SQ-466

Description: When routing CAPAs to a new version the property “Changes In this Version” is visible on the Metadata Card.

Improvement: Bug fixed. Property “Changes In this Version” is removed when CAPA is routed for a new version.

ID: SQ-470

Description: When CR scope had a product item added, which got removed, the users could not select this product item for another change request.

Improvement: Bug fixed. Product items can be added and removed from a CR Scope.

ID: SQ-471

Description: Due Date of an Action could not be set to today’s date.

Improvement: Bug fixed.

ID: SQ-332

Description: The property “Latest Review Close Date” is recalculated in the state “Review Closed”, when a document or metadata change has been made.

Improvement: Bug fixed.

ID: SQ-479

Description: The Property “Date Approved Formatted” hasn’t been processed in certain workflow states for Documents. This led to an empty value after PDF renditioning.

Improvement: Bug fixed.

The post SimplerQMS 3.0.4 Release Notes (Patch) appeared first on SimplerQMS.

Effective Date: 2023-06-23

ID: SQ-310

Description: When creating a recorded issue and setting the property Reportable on RI = No it still required a report.

Improvement: Bug fixed.

ID: SQ-285

Description: Improved user experience for opening documents attached to a training record.

Improvement: After opening the tree structure of a training record the document to learn is directly visible without the need to open the “Version(s) to learn” tab.

ID: SQ-333

Description: The created date has been incorrect on released documents, as it has used the created date of the released version instead of the original document.

Improvement: The property “Created Formatted” can be inserted on documents in order to apply the creation date of the initial document.

ID: SQ-457

Description: Existing Attachments that have been routed for updates stayed in “read-only” permissions.

Improvement: Bug fixed.

ID: SQ-464

Description: Permissions have not been updated on templates, which have been routed for updates.

Improvement: Bug fixed.

The post SimplerQMS 3.0.3 Release Notes (Patch) appeared first on SimplerQMS.