Germans Frolovs, Author at SimplerQMS https://www.simplerqms.com/author/gfsimplerqms-com/ Ready-to-use eQMS for Life Science Tue, 21 Nov 2023 10:08:04 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.2 https://www.simplerqms.com/wp-content/uploads/2020/09/SimplerQMS-Logo-300x300-1.png Germans Frolovs, Author at SimplerQMS https://www.simplerqms.com/author/gfsimplerqms-com/ 32 32 SimplerQMS 3.1.2 Release Notes (Patch) https://www.simplerqms.com/knowledge-base/3-1-2-release-notes/ Tue, 21 Nov 2023 10:00:46 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=249582 See release notes for SimplerQMS patch 3.1.2.

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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.

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]]> SimplerQMS 3.1.1 Release Notes (Patch) https://www.simplerqms.com/knowledge-base/3-1-1-release-notes/ Thu, 19 Oct 2023 10:51:48 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=249524 See release notes for SimplerQMS patch 3.1.1.

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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).

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]]> SimplerQMS 3.1 Release Notes (Major Release) https://www.simplerqms.com/knowledge-base/3-1-release-notes/ Tue, 03 Oct 2023 15:46:55 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=249392 See release notes for SimplerQMS 3.1.

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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

2.1. Major New Features

CategoryDescription
Non-Quality FilesNew document Class
The File class is tailored for non-quality related documentation, providing a seamless solution for efficient organization and management of your files. Optional metadata enables you to organize your files with ease and find them in view structures together with your quality documentation, creating more transparency between departments. Filed records maintain the original file name and format without PDF conversion. New Work Instruction. (SQ-260, SQ-370)
Home DashboardPersonalized metrics right on the front page
A revamped home dashboard, putting personalized metrics at your fingertips. Stay on top of pending training, actions and tasks, and effortlessly manage documents assigned for your review and approval, all from one convenient hub. Updated Work Instruction. (SQ-461)
Visual WorkflowsGain a clear, visual representation of workflows
Easily gain a clear, intuitive representation of our workflows, identify the next and previous steps, and access valuable additional information through convenient links to the Knowledge Base. Updated Work Instruction. (SQ-198, SQ-426)
Customer AuditManage customer audits
Enhancing your audit management capabilities within SimplerQMS, customer audits receive the same comprehensive feature set as other audit classes. This change is aimed at simplifying your audit management and ensuring that you can maintain detailed records of your customer-related audits. Updated Workflow. (SQ-247)
Permission DelegationDelegate Responsibility during Extended Leave or Departure
You can now delegate Responsible Person and Author permissions from one user to another, whether on a permanent basis or until a specified expiry date. Documents on classified document types are respected by this feature. Updated Work Instruction. (SQ-61, SQ-403)

2.2. Major Improvements

CategoryDescription
Supplier Audit flowAdded workflow for documentation
Supplier audits feature has an added workflow path for collecting requested documentation during the audit. This provides an alternative to the supplier issue/CAPA process or confirming no findings during the audit. Updated Workflow. (SQ-469)
Recorded IssuesInitial review before Issue Handling
All recorded issues now allow the option of an initial review process before being sent for Issue Handler Assessment, allowing more stakeholders to provide data and resolution on issues raised. Updated Workflow and Updated Work Instruction. (SQ-447)
Equipment
Supplier
Tasks & Actions		Reassign to Responsible Person(s)
In editable states for equipment, suppliers, actions, or tasks the existing Responsible Person (RP) has the ability to define new Responsible Person(s) in the metadata. This feature allows for a smooth transition of responsibility, refreshing the metadata and ensuring that these objects are assigned to the newly defined individuals. Updated Work Instruction. (SQ-504)
Doc Control
Quiz		Reassign to New Author(s)
In the states of New Draft and Await Updates the “Reassign to New Author(s)” state transition is applied for Templates, Change Requests, CAPAs, Recorded Issues and Collections. This reassignment can be carried out by either the Responsible Person or the Process Manager. Clicking the state transition refreshes the document’s metadata and ensures that the document is assigned to the newly defined authors. Updated Work Instruction. (SQ-485)
CAPAView all CAPA Actions in a property
A new metadata property designed to collect and consolidate all CAPA-related actions on the CAPA metadata card, making it easy to assess if all necessary actions are related. (SQ-494)

Justification to reschedule CAPA Effectiveness
A mandatory justification property is implemented when rescheduling CAPA Effectiveness Assessments. The added metadata property ensures that important details surrounding the rescheduling decision are captured and documented. (SQ-488)
ProductProduct Lot expiry date
Product lots now include optional expiration date and transition to an “expired” state on the defined date. Product Managers can choose to archive expired lots so that these archived lots no longer can be used as a reference for documentation. Expired lots are assigned to Product Managers, who will have the authority to archive the expired lots once all related documentation is completed. (SQ-489)
Controlled PrintingAvailable on old documents and templates
If Controlled Printing is enabled, it now applies to all documents and templates, including historical ones created before the feature was turned on. While overlays are not applied to these pre-existing records, you can still utilize Controlled Printing to create controlled print items as needed. (SQ-500, SQ-502)

2.3. Minor Updates

CategoryDescription
UI ImprovementsIcon unification
We’ve made an important enhancement to the visual consistency of our platform. Icons have been unified across different workflow states and object creator buttons. With consistent icons, navigating through workflow states and creating objects becomes more straightforward, reducing the learning curve and ensuring a seamless user experience for all our users. (SQ-169)
Periodic TaskNew property for Affected Processes
Processes can now be related to periodic tasks. (SQ-509)
AuditProcesses available on all audit classes
Regulatory Inspections and Supplier Audits now have a metadata field for Affected Processes to capture the audit scope. (SQ-97)
GeneralOptimised Built-in views
Views related to the Home Dashboard have been enhanced to provide comprehensive data. All Documents view includes the File class so quality and non-quality records can be viewed together seamlessly. Enhanced Person view includes columns for delegated employees.

2.4. Bug Corrections

  1. SQ-539: Due Date remains filled on docs and templates after update.
    Fix: Due Date emptied out at Awaits Updates on Docs and Templates.
  2. SQ-488: CAPA Effectiveness Assessment title captures for learning state.
    Fix: State name removed from default title.

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.

File Class Metadata Card

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.

Click to View a PDF

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.

Controlled Document Visual Workflow

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.

Visual Workflow Symbol Legend

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.

Visual Workflow Dropdown

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.

SimplerQMS Home Dashboard

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.

Home Dashboard One Click View

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.

Home Dashboard Last Updated Time

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.

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]]> SimplerQMS 3.0.6 Release Notes (Patch) https://www.simplerqms.com/knowledge-base/3-0-6-release-notes/ Thu, 24 Aug 2023 08:00:18 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=249260 See release notes for SimplerQMS patch 3.0.6.

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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.

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]]> SimplerQMS 3.0.5 Release Notes (Patch) https://www.simplerqms.com/knowledge-base/3-0-5-release-notes/ Fri, 04 Aug 2023 08:23:48 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=249251 See release notes for SimplerQMS patch 3.0.5.

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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”.

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]]> SimplerQMS 3.0.4 Release Notes (Patch) https://www.simplerqms.com/knowledge-base/3-0-4-release-notes/ Mon, 17 Jul 2023 10:36:37 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=249218 See release notes for SimplerQMS patch 3.0.4.

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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.

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]]> SimplerQMS 3.0.3 Release Notes (Patch) https://www.simplerqms.com/knowledge-base/3-0-3-release-notes/ Fri, 23 Jun 2023 08:24:55 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=249052 See release notes for SimplerQMS patch 3.0.3.

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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.

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]]> SimplerQMS 3.0.2 Release Notes (Patch) https://www.simplerqms.com/knowledge-base/3-0-2-release-notes/ Wed, 24 May 2023 10:23:11 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=248828 See release notes for SimplerQMS patch 3.0.2.

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Effective Date: 2023-05-23

ID: SQ-37

Description: Disable the “warning message” where users are told that permissions are changing.

Improvement: Improving the user experience. Prompt messages reminding of a potential loss of permissions when changing or creating a document have been disabled.

M-Files Permission Change Notice

ID: SQ-171

Description: Clean up/remove obsolete settings on the admin site.

Improvement: Performance improvement. No changes to the user interface.

ID: SQ-220

Description: Admin accounts selectable option in customer’s systems.

Improvement: Bug fix. In some cases, an admin account has been showing up as a value selection item.

ID: SQ-263

Description: Nearly invisible icons on metadata card.

Improvement: UI improvements. The ribbon bar color on the metadata card caused low visibility of icons.

ID: SQ-296

Description: Include Dateformatter in SimplerQMS App.

Improvement: Performance Improvement. No changes to User Interface.

ID: SQ-300

Description: Change Site Permission Model: Using User Groups instead of Users for Site Permissions.

Improvement: Improving performance for recalculation of permissions on objects when removing or adding users to the site, resulting in faster permissions processing for adding/removing users to a site.

ID: SQ-301

Description: Upgrade VAF to the newest version.

Improvement: Stability Improvement. No changes to User Interface.

ID: SQ-305

Description: Replace “Set property” event handlers.

Improvement: Performance Improvement. No changes to the User Interface.

ID: SQ-309

Description: Reduce versioning amount caused by workflow steps.

Improvement: Performance Improvement. No changes to the User Interface.

ID: SQ-311

Description: Combine vault applications into one.

Improvement: Performance Improvement. No changes to the User Interface.

ID: SQ-313

Description: Check the Dateformatter vault app for “Set properties” event handlers.

Improvement: Performance improvement. No changes to the User Interface.

ID: SQ-314

Description: Suggestion to new assign to rule on docs in state modify reviewers list.

Improvement: For Controlled documents, Templates, CAPAs, and Change Requests assignments have been sent out to multiple recipients when modifying the reviewer’s list. Assignments will be only sent out now to the person making the change.

ID: SQ-315

Description: Clean up Unique Number Sequence / Unique Number Enforcement.

Improvement: Removing Legacy Data, Improving Performance. Improving the title of “Periodic Reviews” by using the version numbering of the related released document.

ID: SQ-316

Description: Update Compliance Kit (v21.12.1057.19).

Improvement: Improve System Stability. No changes to the User Interface.

ID: SQ-322

Description: Give Related Person(s) access to documents even if on Classified DocType or Project.

Improvement: Only people mentioned on the metadata in ROLES have been able to see the docs, and those given access to the doctype. Changed so “Related persons” will receive access to the documents as well.

ID: SQ-335

Description: Optimized “Controlled Document Processing” Workflow.

Improvement: Improving Performance by reducing the versioning amount. Workflow processes running in the backend have been improved.

ID: SQ-336

Description: Optimized “CAPA Document Processing” Workflow.

Improvement: Improving Performance by reducing the versioning amount. Workflow processes running in the backend have been improved.

ID: SQ-337

Description: Optimized “Change Request Document Processing” Workflow.

Improvement: Improving Performance by reducing the versioning amount. Workflow processes running in the backend have been improved.

ID: SQ-342

Description: Workflow: Periodic task processing – permission to sign.

Improvement: Bug fix. Responsible persons have been not able to complete periodic tasks.

ID: SQ-354

Description: Clean-up Managed Properties.

Improvement: Removing legacy data. Improving performance by removing not used settings.

ID: SQ-355

Description: Clean-up Version Control Lite.

Improvement: Removing legacy data. Improving performance by removing not used settings.

ID: SQ-359

Description: Clean-up Object Creator.

Improvement: Removing legacy data. Improving performance by removing not used settings.

ID: SQ-366

Description: Uninstall the obsolete UI extension “Theme Editor”.

Improvement: Removing legacy data. Improving performance by removing not used applications.

ID: SQ-369

Description: Optimized “Controlled Doc.Collection Processing” Workflow.

Improvement: Improving Performance by reducing the versioning amount. Workflow processes running in the backend have been improved.

ID: SQ-414

Description: Template Authors have been able to move the template from Review Ongoing → Modify Reviewers list, even though they are not able to do changes to the document’s metadata in this state.

Improvement: Permissions for doing the state transition have been removed.

ID: SQ-415

Description: Template Authors have not been allowed to do the state transitions for the templates:

  • Review Ongoing → Reject Template – Send Back to Draft for Editing
  • Review Closed → Reject Template – Send Back to Draft for Editing
  • Awaits Approval Signatures → Reject Template – Send Back to Draft for Editing

Improvement: All transitions which lead to a new draft are now allowed to be done for “Template Author(s)”.

ID: SQ-417

Description: Some customers have experienced errors when routing a document for a new update.

Improvement: Has been fixed for the affected workflow: Controlled Document Processing.

ID: SQ-420

Description: When an unreleased document with the workflow “Controlled Document Processing” is rejected from approval, it goes to “Awaits Updates”.

Improvement: Changed the state transition to travel to the correct state “New Draft”.

ID: SQ-421

Description: When a template in version 2 with the workflow “Controlled Template Processing” is rejected in the approval or review state, it travels to “New Draft”.

Improvement: Fixed by defining the correct state “Awaits Template Update”.

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]]> SimplerQMS 3.0.1 Release Notes (Patch) https://www.simplerqms.com/knowledge-base/3-0-1-release-notes/ Wed, 05 Apr 2023 08:03:51 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=248059 See release notes for SimplerQMS patch 3.0.1.

The post SimplerQMS 3.0.1 Release Notes (Patch) appeared first on SimplerQMS.

]]> Effective Date: 2023-04-04

ID: SQ-298

Description: Processes are by mistake mentioned as an added property based on the template target class. The issue is that it gets populated to all Change Request Templates.

Improvement: The risk is small as it is only on the template and not the actual Change Request record that the setting is incorrect, but it can add to the confusion as it is not expected. The action is to change the metadata card configuration from property “Processes” to “Affected Processes”.

ID: SQ-297

Description: On document types, the property “SimplerQMS Settings List” is not read-only, and Requires Controlled Printing is visible and required as a default setting. The current setting is not as expected and requires configuration that is not needed.

Improvement:

  • Change the setting on the class “Document Type” where “Requires Controlled Printing” should not be required.
  • Metadata card configuration changes to ensure read-only on “SimplerQMS Setting List” and “Controlled Printing”.

The changes in the patch ensure that when creating a new document type, only values relevant to the customer’s needs are to be filled.

ID: SQ-318

Description: Recorded Issue workflow problem – does not allow for signing for “No CAPA Needed” and having values in “Reporting Details”.

Improvement: Ensure that the Recorded Issue Workflow allows signing for No CAPA needed in the Issue Handler Assessment state when Reporting details are present. The changes eliminate the risk that the recorded issue workflow cannot move forward if this combination of variables is present.

ID: SQ-320

Description: View column update – for Document Types.

Improvement: Remove the column for “Controlled Printing” – as it is not relevant information when Controlled Printing is not Enabled (Currently for all customers).

The post SimplerQMS 3.0.1 Release Notes (Patch) appeared first on SimplerQMS.

]]> SimplerQMS 3.0 Release Notes (Major Release) https://www.simplerqms.com/knowledge-base/3-release-notes/ Fri, 24 Mar 2023 15:30:43 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=247825 See release notes for SimplerQMS 3.0.

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]]> Effective Date: 2023-03-24

1 Introduction

1.1 Purpose of the Document

This document describes the differences between SimplerQMS 2.9 and SimplerQMS 3.0.

1.2 Objectives for SimplerQMS 3.0 based on customer feedback

Majority of the changes in the SimplerQMS 3.0 release has been driven by user feedback. The changes are divided into major and minor updates of existing functionality from SimplerQMS 3.0.

There are no prerequisites in SimplerQMS 2.9 to be met or managed by customers, prior to roll-out of SimplerQMS 3.0.

2 Summary of 3.0 release

2.1 Major New Features

CategoryDescription
Action FeatureNew versatile action feature replacing assignments.
A new action feature has been introduced to allow users for creating quick actions for the user itself and others. Options such as setting due dates and grace periods, relating documents, requiring multiple assignees to complete and eSignature requirements can be customized. Watch the video here.
License OverviewNew Licenses Dashboard to see allocated licenses.
A new license overview provides Metadata Administrators insights to total number of licenses purchased, license assignments for all users, who is logged in and a force log-out feature to release concurrent license seats for other users. Watch the video here.
Controlled PrintingManage controlled prints and downloads.
Record all print details such as print reason, who printed and when. Track printout status, recall print-outs and monitor all controlled copies in circulation. This feature is not automatically activated. Please contact your SimplerQMS Training & Implementation Lead for more info. Watch the video here.

2.2 Major Improvements

CategoryDescription
Performance ImprovementsImproved performance in document control workflow.
Overall improved system performance incl. process time within frequently used document workflow steps like “Send for Review” and “Route for Approval”. Additional system-wide performance improvements are planned and will be pushed out in patches over the next months.
TemplatesTemplate properties adapt to selected Target Class.
Based on the selected Target Class the metadata card properties will change to allow defaulting of values on resulting document. The template metadata card is also reorganized to create clear separation between Template specific properties and properties used for defaulting on resulting document. This also mean that the Insert Property dashboard includes all field codes relevant for the creation of the right templates. Watch the video here.
TemplatesTraining on templates.
Templates can be added to learning rules and assigned for learning. Training Records are issued like on Quality Document learning and need to be signed with Read & Understood.
TemplatesRevision history.
To capture changes made from one version to another, the metadatacard includes a “Changes in This Version” field for capturing version specific changes and a Complete Change History that combines all previous changes. The change history is added to the released version of the template document. If controlled by CR, the CR number is automatically captured in change history.
Change ControlControlled Items are now optional add.
Change Requests can run with empty scope without Documents, Templates or Product Items to Update or Retire. Watch the video here.
Change ControlOther Affected Items section.
Affected Processes and Relations are added to a new section Other Related Items on the metadatacard. This allows choosing multiple processes that can be related to the Change Request. Items added in Relations and Affected Processes are not controlled by the CR in a system perspective, they are only related to the CR.
Recorded IssuesSimplified reporting workflow.
MDR Reporting is replaced by Vigilance Reporting, a two-step process consisting of Reporting Pre-Assessment and Vigilance Reporting. Reporting is completed by Issue Handler. The new Vigilance Reporting can be enable/disabled for each Recorded Issue Type. Watch the video here.
Recorded IssuesConfigurable Recorded Issue Types.
In addition to the Vigilance Reporting is configurable for each Recorded Issue Type, the Display Names of recorded issues can be customized according to industry standard terms (e.g., Nonconformances —> Deviations).
EquipmentEquipment can be set to “On Hold”.
When out of service, both Standard and Quality Critical equipment can be set on hold. Quality Critical Equipment on hold will need assessment after on hold to determine if calibration state is unaffected or needs recalibration. Watch the video here.
SuppliersSuppliers can be set to “On Hold”.
When not to be used, both Standard and Quality Critical suppliers can be set on hold. Quality Critical Supplier on hold will need assessment after on hold to determine if qualification state is unaffected or needs requalification.

2.3 Minor Updates

CategoryDescription
Actions & TasksManually created periodic tasks carry values over to new task.
Several properties were not copied over and caused missing references. When a new task is created properties are copied over from old task to new one.
Actions & TasksQuality Assurance Responsible (UG) can complete periodic doc review.
Matched access rights to Responsible Person and Process Manager.
Doc. ControlReassign to New Author(s).
In the State New Draft and Await Updates when new authors are defined on the metadata document can be reassigned to new authors. This will refresh the metadata and adding the document to new people defined.
EquipmentNew field for Equipment Serial Number.
A free text field that allows any form of input for capturing Serial Number of Equipment for better traceability.
GeneralImproved Masterdata Views.
General views only show current masterdata. Introduction of a new combined view of all archived masterdata categorized based on class.
GeneralOptimised Built-in views.
Introduced more relevant columns.
GeneralImproved parent / child masterdata relationships.
Archives, Departments, Projects, and Processes have parent/child relationship displayed. Improved navigation structure in views.
LearningCombined Learning Rules for Documents, Templates and Quiz.
Learning for Templates, Documents and Quizzes can be managed on one combined learning rule instead of Document and Quiz learning rules. Watch the video here.
PersonDepartment property migrated out of Access Permissions.
Improved overview on Person metadata card. Property moved under Training Group at the top instead of being hidden under Employee Access Rights.
ProductProduct Hierarchy removed from Product metadata.
Historic feature that was not usable removed from metadata.
SuppliersSupplier Type field is multi-select and values can be added.
Along the Direct and Indirect default features, supplier type can capture more details about the customer based on a self-defined value list.
TemplatesRetirement Date in optimal place.
Set Retire Date field moved up on the metadata to a more logical place.
TrainingTraining Record permissions restricted.
Training records are not accessible by any user in the system, only by Training Manager, Supervisor and the Person themselves.

3 New Action feature

A new enhanced action feature replaces the assignment function.

It allows users for creating quick actions for the user itself and others.

SimplerQMS Action Workflow

Some of the key features are:

  • Set due date and grace periods to allow future actions
  • Add the affected processes and any relevant documents and other objects to an action
  • Request that one or all assignees complete the action – and determine if electronic signatures are required
  • Flexible workflow allowing for completion, rejection and discarding of Actions
  • For Actions related to CAPA or Change Requests, the action will block approval of these documents until Action is completed
Action Metadata Card in SimplerQMS

4 License Overview

With the new License Dashboard, it is now possible to get a full overview of your licenses. The Metadata Administrator can:

  • View the total number of licesens purchase for each license type
  • See a list of who is logged in and logged out for each license type
  • Force log-out of concurrent users, in case they forget to logout
SimplerQMS License Dashboard Overview

5 Controlled Printing

The new Controlled Printing feature is available upon request.

Controlled print item results - success or failure

This will control printing and download of released Templates and Quality Documents and add unique footers to track all copies generated:

  • Record all print details such as reason for printing, a unique print number, who printed and when
  • Track printout status and recall print-outs to ensure they are destroyed
  • Monitor all controlled copies in circulation
  • In the setup process, you can determine what documents are in scope for each document type
Controlled and uncontrolled print item example comparison

This feature is not automatically activated. Please contact your SimplerQMS Training & Implementation Lead for more info.

6 Bug Corrections

  1. Bug: Documents under Change Control could be retired with the periodic document review flow.
    Fix: CR requirements added to retire the documents.
  2. Bug: CR could get stuck when retiring, if too many objects assigned.
    Fix: Workflow updated to manage all documents.
  3. Bug: Documents could still be released if PDF processing failed.
    Fix: Documents are prevented from released if PDF processing fails.
  4. Bug: In CRs, conclusions were deleted when routed to draft.
    Fix: Conclusions are not deleted anymore.
  5. Bug: Admin account could be selected in some cases when assigning to training groups.
    Fix: Admin accounts are hidden.
  6. Bug: In special cases, documents could stay checked out by M-Files.
    Fix: Resolution has been implemented in backend.
  7. Bug: A CR related view “Document on retired templates” had an incorrect filter setting showing old CRs from version 2.7 and prior.
    Fix: Filter has been updated.
  8. Bug: If controlled items were added to a CR and then deselected again, references to the deselected items continued to appear.
    Fix: Controlled Item property updated.

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