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Discussions

Ask a question or engage in conversation about industry, professional challenges, platform experiences, or any other relevant topics.

  • 119 Posts
  • 196 Replies
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119 Posts
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A
Anonymous
 Discussions
Proven strategies: how do you maintain high quality in regulated industries?
Proven strategies: how do you maintain high quality in regulated industries?Blog

 Rebecca WatsonIn the complex landscape of regulated industries, quality isn't just a desirable trait — it's a non-negotiable prerequisite. These sectors operate under stringent regulations set by governing bodies to ensure safety, fairness, and quality.  Quality in this context transcends mere customer satisfaction — it often constitutes a legal obligation and invariably provides a competitive edge. It encompasses meeting and surpassing client expectations, ensuring regulatory compliance, and fortifying a reputable brand that enhances consumer trust and loyalty. Quite simply, quality matters. The repercussions of a lapse in quality can be severe. From product recalls to data breaches, the financial implications can be staggering, as can the impact on brand reputation, which can take years to restore. Take the horsemeat scandal and Mad Cow Disease as examples. Recent research carried out by Ideagen demonstrated that there was still diminished trust with consumers, decades after the eve

330
A
1 year ago
Samuel Brown
Ideagen Community Manager
Samuel BrownIdeagen Community Manager
 Discussions
ISO 13485:2016 7.3: Medical device design controls and why they’re important
ISO 13485:2016 7.3: Medical device design controls and why they’re importantBlog

 Aaron HoareMedical device design controls are a set of policies and practices intended to ensure consistent translation of input requirements into a physical product that meets those requirements.Good design controls are important to:Reduce product risks Demonstrate your product is fit for purpose Align your organizationISO 13485:2016 sets out a series of requirements for design controls. So how can you actually apply, manage and use our software to ensure you are compliant with ISO 13485 design control requirements?Each of the sub-clauses in 7.3 require documented SOPs (Standard Operating Procedures). Our software takes this one step further – it enables you to enforce each of the procedures, making quality by design and default.It's a much more natural way to plan, record and manage quality - an approach preferred by auditors. Rather than SOPs which are bolted-on, they are embedded. Quality is part of the culture. It's no longer a "quality management system" as such, it's the busine

2830
Samuel Brown
Ideagen Community Manager
1 year ago
Ellie Roser
Ideagen Community Manager
Ellie RoserIdeagen Community Manager
 Discussions
CAPA for ISO 13485: medical devices
CAPA for ISO 13485: medical devicesBlog

 Aaron HoareEffective CAPA management is essential in the medical device industry, with corrective and preventive action a core pillar of ISO 13485. ISO 13485 is the international standard for demonstrating a commitment to quality, and the importance of CAPA is clear throughout the standard – not to mention it having two dedicated clauses, 8.5.2 and 8.5.3, for corrective and preventive action respectively.So, in simplest terms: CAPA management for ISO 13485 is essential, and by extension is important for all types of medical device organization. Meeting the demands of ISO 13485 would be impossible without sound CAPA management.Without being firmly in control of your corrective and preventive actions, you open up your medical device quality management system, and your entire organization, to intense scrutiny and avoidable risk. Not to mention, opening up patients to potential harm.Working to eradicate non-conformances and preventing them from reoccurring is central to pursuing continuou

1020
Ellie Roser
Ideagen Community Manager
1 year ago
M
Thinker
Martin GomezThinker
 Discussions
Link document to another one

Hi, is there a way to link two or more different documents to each other? Basically, if one document is changed, systematically review the possible impact on the other document(s) .  I’m aware of the Related documents section on the properties, but, even though there were documents in that section, I still was able to revise any document without reviewing the related documents.

1771
Sam Jackson
Ideagen Employee
1 year ago
Samuel Brown
Ideagen Community Manager
Samuel BrownIdeagen Community Manager
 Discussions
The foundation for effective implementation of electronic quality management systems
The foundation for effective implementation of electronic quality management systemsBlog

 Antiksha JoshiThe pharmaceutical and wider life science industry is slowly but surely moving toward Industry 4.0. This is evidenced by the regular entry of new and improved equipment, monitoring systems, and electronic quality management systems into the market, as well as the increased number of regulatory publications on the same.Organizations are increasingly adopting and implementing software-based and automated solutions for many of their quality systems as well as manufacturing processes. The most common, and often the first system any organization implements, is an electronic Quality Management System (eQMS).Choosing and implementing an eQMSWhen choosing and implementing an eQMS, the organization's sole purpose is to reduce human errors and improve efficiency. Once an eQMS is implemented and in use, it is often found that problems have not been resolved, and efficiency has only marginally improved.Often, the QA department is blamed for implementing an eQMS that doesn’t seem to

600
Samuel Brown
Ideagen Community Manager
1 year ago
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

4780
A
1 year ago
Ellie Roser
Ideagen Community Manager
Ellie RoserIdeagen Community Manager
 Discussions
Tell Us Your Go-To Ideagen Quality Management Tip or Trick!
Tell Us Your Go-To Ideagen Quality Management Tip or Trick!

Hey, Ideagen Community!We're reaching out to harness your expertise, so we're curious to know...What’s your go-to tip or trick?It might involve a time-saving shortcut, a savvy technique, a personalised tweak, or any nugget of wisdom you think could aid others.Let's come together to transform this post into a beacon from which we can all potentially maximise our individual platform experiences!

2003
Ellie Roser
Ideagen Community Manager
1 year ago
T
Thinker
TG-1Thinker
 Discussions
Does anyone know how to use the Document Retrieval Service (DRS) with "Sharepoint Online"

The following article shows:How to Use the Document Retrieval Service (DRS) with Sharepoint However this is for SharePoint 2016 and earlier - not SharePoint Online. The support team do not know how to do this.Has anyone done this?

3741
Samuel Brown
Ideagen Community Manager
1 year ago
A
Anonymous
 Discussions
CAPA in manufacturing
CAPA in manufacturingBlog

  Aaron HoareIn the realm of quality management systems (QMS), managing Corrective and Preventive Actions (CAPAs) in manufacturing takes center stage. A strong grip on your CAPAs not only shields your QMS and organization from serious examination, but it also acts as the cornerstone of continuous quality improvement.Key advantages of strong manufacturing CAPA processes include reduced defects, reworks, and out-of-specs; easier adherence to quality standards and regulatory demands; improved efficiency across your organization; better safety standards for end-users; significant reduction in costs.Put simply, CAPA management in manufacturing ensures a process for getting things right first time and, crucially, making sure things stay that way. This is a must for any quality team.If your current CAPA system seems wanting, continue reading this introductory guide to CAPA management. As an alternative, download our more in-depth guide to CAPA in manufacturing below.How to structure a manufac

1360
A
1 year ago
L
Thinker
Lee EvansThinker
 Discussions
Attachment Extraction

Hi All, is there a way of extracting all attachments out of Q-Pulse that have been added to either documents, audits etc

5671
Samuel Brown
Ideagen Community Manager
1 year ago
Samuel Brown
Ideagen Community Manager
Samuel BrownIdeagen Community Manager
 Discussions
Describe Your Before-and-After Experience with Ideagen Quality Management!
Describe Your Before-and-After Experience with Ideagen Quality Management!

Hey, Ideagen Community!We all love a good transformation story, and we bet you've got some exciting ones to share, so take a moment to describe your experience…How did things look before the solution was implemented, and what changes have occurred since?We're ready to hear the good, the bad, and the ugly, so whether that means your experience dictates that pre-solution you were surviving and post-solution you've been thriving or any other variation of how the story could go, we want a reflection of your experience.Your story will reflect the true impact of the solution, so let’s hear those tales!

320
Samuel Brown
Ideagen Community Manager
1 year ago
A
Anonymous
 Discussions
Vote for Which Ideagen Quality Management Feature You Find Most Valuable!
Vote for Which Ideagen Quality Management Feature You Find Most Valuable!Poll

Hey, Ideagen Community!Take a moment to participate in the poll and provide additional comments, insights, or reasoning behind your selection by replying to this post.We appreciate your contributions and can't wait to see the outcome!

1322
A
1 year ago
Ellie Roser
Ideagen Community Manager
Ellie RoserIdeagen Community Manager
 Discussions
Recall an ‘Aha!’ Moment You Had with Ideagen Quality Management!
Recall an ‘Aha!’ Moment You Had with Ideagen Quality Management!

Hey, Ideagen Community!We're sure we're not alone in appreciating a moment of sudden insight or discovery, so it'd be great to know...What's your ‘Aha!’ moment?Discovering a platform function you didn’t know existed, realising the solution could help with a professional dilemma, identifying a special use case for your line of work—these are the types of ‘Aha!’ moments we’re talking about.What you recall could trigger even more 'Aha!' moments, so don’t hesitate to share yours!

1052
Ellie Roser
Ideagen Community Manager
1 year ago
M
Maven
Monika BlinstrubyteMaven
 Discussions
Linking a document to a completed requirement

Hi All, I am hopeful you can help.  I am wondering if there is a more efficient way of linking attachments to relevant competency requirements. We currently upload documents to the “Properties” section on a staff member’s record however it is often difficult to find. Is there a way of linking the two e.g. attaching the document to the requirement upon completion as evidence?   P.S. We are currently using version 6.1.2.4, I am aware it might be the case the newer versions have this function.  Thank you!Monika

4402
A
Thinker
2 years ago
M
Maven
Monika BlinstrubyteMaven
 Discussions
Report Designer

Hi! Hope you can help.I am trying to use the Count function in expressing calculated fields on Q-pulse. So far, I am not getting anywhere, what I want is something as basic as the COUNTIF function on Excel.For example, I would like the report to count the number of fields that show a date that is less than today’s date (e.g. overdue review documents)This is how I have set it up: But it only prints an empty box. Am I doing something wrong? I’ve tried putting it in every single band. It would be helpful to have more in-depth guides for report designer!   Thank you!

6241
Sam Jackson
Ideagen Employee
2 years ago
A
Anonymous
 Discussions
Share a Positive Ideagen Quality Management Experience You’ve Had!
Share a Positive Ideagen Quality Management Experience You’ve Had!

Hey, Ideagen Community!We believe that the best insights come from those who have experienced something first-hand.That's why we want to hear from you about a positive experience you’ve had.For example, you could…Describe a situation where it saved you time, money, or resources Share a specific situation where it helped you achieve a goal or solve a problem Describe a situation where it exceeded your expectations Share a specific situation where it made a positive impact on your daily routineThe experience you share in a reply to this post can offer valuable insight and inspire other users.

200
A
2 years ago
S
Thinker
SamThinker
 Discussions
What is the TLS for Q-Pulse?

What is the TLS for Q-Pulse?

2741
Samuel Brown
Ideagen Community Manager
2 years ago
Naomi Moore
Ideagen Employee
Naomi MooreIdeagen Employee
 Discussions
How does your eQMS support your Business Continuity Management processes?
How does your eQMS support your Business Continuity Management processes?

Does anyone have any examples of how they are using an eQMS to support their Business Continuity Management processes?

320
Naomi Moore
Ideagen Employee
2 years ago
Mr_Colin
Ideagen Employee
Mr_ColinIdeagen Employee
 Discussions
MoC process for an eQMS?
MoC process for an eQMS?

Does anyone have a good example of MoC process they would recommend for an eQMS? Based on Demming? 

980
Mr_Colin
Ideagen Employee
2 years ago
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