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Activity

37
    A
    Anonymous
     Discussions
    ISO 13485 software validation process: everything you need to know
    ISO 13485 software validation process: everything you need to knowBlog

      Aaron HoareWhen you're implementing an electronic medical device quality management system, your ISO 13485 software validation process is of the utmost importance. You'll need to ensure that your system is working, continues to work as expected, and meets the requirements of ISO 13485.ISO 13485 has relatively stringent demands for software validation, with at least 8 clauses in the standard having specific requirements related to validation. Not least, ISO 13485 requires the establishment of a robust quality management system, which most organizations choose to achieve through software – which will, therefore, itself require validation.There are no shortcuts in this process. However, we provide a structured approach that will help you demonstrate compliance to regulations and standards such as ISO 13485 before, during, and long after you've implemented quality management software.What is software validation?Businesses must carefully consider the impact of introducing new software app

    5501
    J
    Thinker
    45 minutes ago
    N
    Thinker
    npurnellThinker
     Discussions
    Viewing and Creating Reports of a Custom Workflow

    Hello, we’ve had QM Essentials for a few years.  My predecessor created 2 custom work flows we primarily use.  We’ve wanted to expand the security on these to include other managers in our lab system.  Currently only myself and a few other QA folks have access as admins.  We’ve enabled the others to view and alter reports, as well as for them to view security in the reports tab for the custom report we’ve created for the custom workflow (that’s been established for years).  The users (who we thought we gave appropriate permissions to) still can’t run the report.  An error message is given.  I understand that maybe embedded within that workflow are additional security measures.  We’ve also enabled workflow definitions for them and within the workflow toggled on view security.  Any ideas on why they still can not run reports? 

    10
    N
    Thinker
    21 hours ago
    M
    Thinker
    Matt Toms St Peter's HospiceThinker
     Discussions
    (Feature Request) Enable notifications based on due dates

    Click “like” to vote for this new feature! (I have no idea if that’s the correct process but hey, hopefully someone from IdeaGen is watching)! We have the requirement across several of our apps to send out notifications to users based on the value of a date-based question answer.In particular a ‘due by’ date when action is needed, for example to update an incident, safeguarding concern, feedback, policy or risk.This might be a reminder that the date is soon, has arrived, or is overdue - and to keep reminding users.Several customers have posted on the forums about this, there are rumours of a fix but no one seems to have implemented it and we’ve been told by consultants and the service desk that it’s not possible. This really should be standard functionality in the product. All it would take is to have a question rule option within Triggers, where: The answer to [date question] is working days from today - with the option to enter a positive or negative numeric value.If this sounds for

    20
    M
    Thinker
    1 day ago
    F
    Thinker
    Frances SindenThinker
     Discussions
    How to create notifications based on due dates

    Is it possible to create a notification email based on a due date on a questionnaire? We would like to be able to send reminder emails to people a couple of weeks before the due date.

    1422
    M
    Thinker
    1 day ago
    M
    Thinker
    Maylene PeelThinker
     Discussions
    Using the Planner for Training reminders

    Good afternoon,Can the Governance Planner be used to set up additional reminders for scheduling and planning training sessions in the next financial year, beyond the standard compliance scheduling? For example, I need to train engineers on hazard identification and risk management.Many thanks,

    161
    Stewart Walker
    Ideagen Employee
    1 day ago
    A
    Ideagen Employee
    Ali HookIdeagen Employee
     Discussions
    Would Document Collaboration Make Your Workflows Easier?

    We’re exploring ways to make your experience with IQM Core even more seamless—and one idea on the table is Document Collaboration.I recently reviewed the Qualtrax Ideas Portal and noticed multiple entries requesting functionality like this. That tells us there’s been interest in the past—but we want to confirm:Is this still something you’d find valuable? Would real-time document collaboration help simplify your workflows?Your feedback is critical in shaping the future of IQM Core. Please share your thoughts in the comments!

    30
    A
    Ideagen Employee
    1 day ago
    E
    Thinker
    EnvironmentalChemistThinker
     Discussions
    Opening documents from the new modern inbox

    Is it possible to go directly to a document from your inbox? I recently switched to the new inbox format and have found the only way to get to a document is by clicking on it, selecting document properties and then opening the document from properties. Frustrating not to be able get directly to the document anymore. 

    30
    E
    Thinker
    2 days ago
    Greg Harper
    Ideagen Employee
    Greg HarperIdeagen Employee
     Technology updates
    No-downtime Production Update (2.63.1.1) starting Thursday, December 11th, 2025

    The No-downtime Production Update on Thursday, November 20, 2025 introduced an issue where special characters in default calculations could fail to work correctly in certain cases. This update reached our European and Canadian data centers on Wednesday, December 3rd. We are addressing the issue with a no-downtime Production Update on Thursday, December 11th, 2025. You can read the release notes for more detail.As always, if you have any questions or concerns, please don't hesitate to contact us.-Greg

    80
    Greg Harper
    Ideagen Employee
    2 days ago
    Greg Harper
    Ideagen Employee
    Greg HarperIdeagen Employee
     Technology updates
    Postponed: No-downtime Production Updates (2.63.2) starting Thursday, December 11th, 2025

    Please be aware that the release previously planned for Thursday, December 11th is postponed until Thursday, December 18th. We always strive to release the highest quality software possible, and in this case, we have identified areas that require further testing to guarantee the high quality that you expect.As always, if you have any questions or concerns, please don't hesitate to contact us.-Greg

    120
    Greg Harper
    Ideagen Employee
    2 days ago
    Ryan Ashley
    Thinker
    Ryan AshleyThinker
     Discussions
    Automated SSO Account Creation - how are you doing it?

    We are a large organization in the process of migrating from on-prem to cloud.We have an automation to create/update/archive users via the API and keep everything in sync with our IDP. The problem is that the API can’t add UPN (User Principal Name), which is required for SSO to work.How are you dealing with this? Certainly you aren’t doing a manual daily bulk upload, which the documentation would leave me to believe is the only option.

    593
    G
    Enthusiast
    3 days ago
    M
    Thinker
    Marwa HussainThinker
     Discussions
    People Module

    Hi , how to create people in the People module and then assign them a Q-Pulse login in the Administration module.Actually i added a user profile on People module and added all training records then realized had not created the user via Administration module. I want to link this profile to the administration module as need to create log in id as well. I checked in the setting i wasnt able to find anything. Please help , as quite a lot of records been uploaded for that profile. Thanks in advance.Best Regards ,Marwa Hussain

    90
    M
    Thinker
    6 days ago
    Jackie Sexton
    Ideagen Employee
    Jackie SextonIdeagen Employee
     Technology updates
    Ideagen EHSQ • Enterprise mobile update for December 4 and December 11, 2025

    We are planning the following no-downtime mobile updates:Android (2.1.0) on December 11, 2025 Recent Assignments and Frequent Items New Relic integration Field-level help text Enhanced mobile submission performance iOS (1.49.0) on December 4, 2025 App rebranding Enhanced mobile submission performance Field-level help text New Relic integration Compatibility with iOS 26 Bug fixes Windows (1.6) on December 4, 2025Brand adoption New app ID Bug fixesFor additional details visit the release notes Ideagen EHSQ • Enterprise 2025 mobile release notes.As always, if you have any questions or concerns, please don't hesitate to contact us.

    70
    Jackie Sexton
    Ideagen Employee
    8 days ago
    C
    Thinker
    CHMSCThinker
     Discussions
    Document Header/Footer

    I am looking to add a header/footer to documents on our system.Is there a viable way to do this. Ideally it would contain the document title, ID and revision number.Has anyone had any experience with this?

    161
    Cody Kestner
    Ideagen Employee
    9 days ago
    B
    Thinker
    Brittany.MeyerThinker
     Discussions
    How do you track major and minor document updates?

    Hello! We are looking at a way to reconfigure out how to set up our document management system in Ideagen to account for major and minor revisions. Essentially our current policy is that we must do a full review of our documents every 2 years, however if minor changes are needed between that those cycles we can do a shortened review before publishing the updates. We do not want these minor reviews to reset the expiration clock for the “full review”.How would you go about using the system to accomplish that?Hope that makes sense!

    141
    Cody Kestner
    Ideagen Employee
    9 days ago
    Alan Blair
    Ideagen Community Manager
    Alan BlairIdeagen Community Manager
     Discussions
    Ideagen Quality Management 7.9 introduces a new user interface
    Ideagen Quality Management 7.9 introduces a new user interface

    We’ve been listening — and now we’re delivering.Based on your feedback, we’re rolling out a brand-new web experience designed to help you work smarter, faster, and with greater clarity.✨ What’s New?🧭 Collapsible Navigation Bar – Maximize your workspace while keeping key modules just a click away. 🗂️ Tabbed Workload View – Manage multiple tasks with ease and stay organized like never before. 🎯 Powerful Filters – Zero in on what matters most and cut through the noise. ⚡ Quick Actions – Complete tasks in record time with streamlined, intuitive controls.This update is all about efficiency, clarity, and getting things done — so you can focus on delivering quality without the clutter.Ready to explore the new interface? Check out the video below and experience the difference!https://share.synthesia.io/abf17d47-9595-45b6-86a2-e76a77d49d10 Ideagen Quality Management 7.9 rolls out December 2025!

    12405
    K
    Thinker
    9 days ago
    Greg Harper
    Ideagen Employee
    Greg HarperIdeagen Employee
     Technology updates
    No-downtime Production Updates (2.63.2) starting Thursday, December 11th, 2025, and Maintenance

    Platform UpdateWe are planning no-downtime updates to deliver Platform release 2.63.2 to the following areas:US Production: Thursday, December 11th Europe and Canada Production: Wednesday, December 17th US Government Cloud Production: Wednesday, January 7th (2026)You can review the release notes for an overview of the changes.ActionPlease report any unexpected behavior that you notice in your US Config (Build, Test, and UAT) areas, which we plan to update with this new version by Friday, December 5th. (We will postpone the Production update if we're not confident in its quality.) This release will reach the European and Canadian Config areas on Wednesday, December 31st.MaintenanceNo-downtime software maintenance on US Production servers:Between Tuesday, December 16th, and Thursday, December 18th. No-downtime software maintenance on European and Canadian servers as outlined in the Maintenance Schedule.As always, if you have any questions or concerns, please don't hesitate to contact us.

    160
    Greg Harper
    Ideagen Employee
    9 days ago
    K
    Thinker
    kamila.lyczekThinker
     Discussions
    Occurnace and incidents

    Hello everyone , I’m working my way through setting the Occurrences and Incidents . I would like the Occurrence to have mandatory field of “Severity”  to enable users to filter through more pressing issue (like in the Capa module ) anyone can help ?

    241
    W
    Thinker
    9 days ago
    Alan Blair
    Ideagen Community Manager
    Alan BlairIdeagen Community Manager
     Discussions
    Ideagen Internal Audit Roadmap (2025 Q3)
    Ideagen Internal Audit Roadmap (2025 Q3)

    We’re thrilled to unveil the new features and enhancements coming to Ideagen Internal Audit!This video gives you an exclusive look at what’s on the horizon—innovations designed to make your processes smarter, more efficient, and easier to manage.Watch now to see what’s changing, what’s improving, and how these updates will help you deliver even greater quality outcomes.https://app.screendesk.io/recordings/24db5384-bcb4-4e17-a887-d43e806a0ab7

    80
    Alan Blair
    Ideagen Community Manager
    11 days ago
    B
    Thinker
    Bthoma4Thinker
     Discussions
    NAME Accreditation Checklist

    Good morning,We are curious if any organizations currently use Qualtrax for your NAME accreditation and how your incorporate your NAME checklist into the system? Is it helpful for you?

    601
    W
    Thinker
    11 days ago
    P
    Thinker
    Paul LThinker
     Discussions
    Using the deputy function in administration

    I want to use the deputy function in the administration module for a staff member who will be away a fixed period.  I believe this should send all the CAPA and document notifications and escalations to the deputy and allow them to action against his name. Is this correct? Does any one have any experience of using this function? Thanks Paul  

    120
    P
    Thinker
    15 days ago
    W
    Thinker
    wils1975Thinker
     Discussions
    Geometric Symbols Missing

    Has anyone else had the issue since the rebrand where the Geometric symbols are no longer present

    40
    W
    Thinker
    17 days ago
    D
    Enthusiast
    Duncan CribbEnthusiast
     Discussions
    Decimal places for pie charts

    I’m trying to get the percentages on a pie chart to display the value with decimal places but can’t seem to find a way to do it. I’m using version 25.

    60
    D
    Enthusiast
    17 days ago
    L
    Thinker
    Lori McWhirterThinker
     Discussions
    Importing Audit Plan

    Good morning, I'm having trouble importing my audit plan.

    181
    Samuel Brown
    Ideagen Community Manager
    17 days ago
    N
    Thinker
    Nick DaviesThinker
     Discussions
    Automatic response to new complaint

    I am using IQM Pro version 7.7.0.0 and would like to set up and automatic email response when a complaint submitted through web reporting meets a given criteria, is this possible?

    211
    Sam Jackson
    Ideagen Employee
    19 days ago
    S
    Thinker
    sarahThinker
     Discussions
    Linking related assets

    In the documents module, you can link related documents in Document Properties Editor. Is there a way to setup something similar in the Assets module? We’d like to link related assets by their unique numbers.

    130
    S
    Thinker
    21 days ago
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