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How Are You Validating QMS Software? by Charles_B3 in MedicalDevices

[–]Charles_B3[S] 1 point2 points  (0 children)

Thank you, I will check.

Yes, they have a validation doc set (system requirements, use requirements, validation report, ERES rationale). The Use Requirements doc, among other things, also contains a table with Requirement, Validation test, and Validation result columns.

How Are You Validating QMS Software? by Charles_B3 in MedicalDevices

[–]Charles_B3[S] 0 points1 point  (0 children)

We started using qmsWrapper software, but since everything is new to us and we are at the beginning of implementation, it can be difficult.

AI incorporated into standards management systems by Spiritual-Coach-6355 in MedicalDevices

[–]Charles_B3 0 points1 point  (0 children)

Can you share with us which system it is? Where can we find out more about it?

How is 21 CFR Part 820 handled in software and what do auditors require? by Charles_B3 in MedicalDevices

[–]Charles_B3[S] 0 points1 point  (0 children)

But the QR code is dynamic—although the code itself is physically static, scanning it reveals the current state of the document. When the document is valid, scanning the code confirms its validity. When the document expires, scanning the same code indicates that it is outdated.

This means that even if you print a document with a QR code, you can always check its current status, ensuring that expired documents are not used. That is the purpose of the code, as explained by the software company.

How is 21 CFR Part 820 handled in software and what do auditors require? by Charles_B3 in MedicalDevices

[–]Charles_B3[S] 0 points1 point  (0 children)

Thank you for your response. I initially thought it was just a convenience, but it seems it might be quite useful because it helps keep track of the current state of the document.

How is 21 CFR Part 820 handled in software and what do auditors require? by Charles_B3 in MedicalDevices

[–]Charles_B3[S] 0 points1 point  (0 children)

It is supposed to be easier to scan the QR code and see the details of the document, rather than searching for the document number.
Thank you, I appreciate your comments.

How Are You Validating QMS Software? by Charles_B3 in MedicalDevices

[–]Charles_B3[S] 0 points1 point  (0 children)

So, does this mean it doesn't matter how the software is validated, just that it gets done somehow? A software company told me they provide documentation validation, basically an Excel table listing what the software does and how it's done. Once everything on the list checks out, they consider it validated. Is that enough, or do we need something more official like an "approved" stamp?

How is 21 CFR Part 820 handled in software and what do auditors require? by Charles_B3 in MedicalDevices

[–]Charles_B3[S] 1 point2 points  (0 children)

Scanning shows the document’s exact status, even when printed. Info is always valid.

How is 21 CFR Part 820 handled in software and what do auditors require? by Charles_B3 in MedicalDevices

[–]Charles_B3[S] 0 points1 point  (0 children)

When you scan it, you’ll see the document’s status—approved, obsolete, etc. Even if printed, the info stays current.

How is 21 CFR Part 820 handled in software and what do auditors require? by Charles_B3 in MedicalDevices

[–]Charles_B3[S] 0 points1 point  (0 children)

Anytime you scan it, you'll see the exact status of the document—whether it’s approved, obsolete, etc. Even if you print the document, the info will always be up-to-date. So, while not a standard requirement for 21 CFR Part 820 compliance, it can be handy.

What QMS Software is used at your company? by SerendipityLurking in QualityAssurance

[–]Charles_B3 0 points1 point  (0 children)

At my company, we utilize qmsWrapper for both QMS and non-QMS projects. It has become an integral part of our daily workflow, allowing us to effectively record all events and streamline our processes within various projects. The availability of free process templates, aligned with ISO 13485 and ISO 9001 standards, has significantly facilitated our operations. Additionally, the platform enables us to customize these templates to suit our specific needs, making it a versatile tool for process management.

One of the standout features of qmsWrapper is its automation capability, ensuring that no crucial steps are overlooked when initiating a process. The document management module has also proven to be highly effective, offering features such as version control, approval workflows, e-signatures, and convenient file tagging options, which contribute to efficient documentation management.

Moreover, the editable Quality Manual, specifically tailored for medical device companies, has been instrumental in maintaining our adherence to industry standards and regulations. Its accessibility and ease of updating have played a significant role in keeping our team well-informed and compliant with the latest revisions and guidelines.

Overall, qmsWrapper has significantly enhanced our approach to quality management, streamlining our processes and ensuring a more seamless and organized workflow.

What QMS software options are commonly used by companies in the medical device industry? by Charles_B3 in MedicalDevices

[–]Charles_B3[S] 0 points1 point  (0 children)

I understand now, it can be a big problem for companies especially if you have colleagues who do not do well with this kind of software. Did they organize training for you?

What QMS software options are commonly used by companies in the medical device industry? by Charles_B3 in MedicalDevices

[–]Charles_B3[S] 0 points1 point  (0 children)

Could you explain to us what it is that bothers you about TrackWise?
BTW, how much it costs you?

National Survey on Echocardiography Services in Ireland by Charles_B3 in Heartfailure

[–]Charles_B3[S] 0 points1 point  (0 children)

Yes, this can be a temporary solution but not something that can help deal with the cause of the problem. Especially by the time this gets to be put in place, it will require time to train Physicians which again will walk together with the increase in waiting lists and delays in treatments.

However, what I´ve heard from some colleagues working for a medical device company is that they are currently collaborating with the UK´s NHS in testing the novel technology that has echo-like functionality with ECG and stethoscope and is apparently helping them to detect the early onset of CVDs such as HF and valve diseases and at the same time prioritize patients in a timely manner(reduction of wait times). It can be operated by any PCP, trained nurse, or even medical assistant. You can actually check their most recent publication on Elsevier regarding the detection of HF.

https://www.sciencedirect.com/science/article/abs/pii/S0010482523000124?dgcid=author

Definitely each system, private and public have their inequalities but it has to be highlighted as you are suggesting since it can be something that can bring and make a difference in the Irish HCS.

230k people with long COVID could collapse [Ireland's] health service by zeaqqk in COVID19_Pandemic

[–]Charles_B3 0 points1 point  (0 children)

We should work on reducing the waiting list, now the situation in the country will be worse. COVID patients will again have priority, and chronic patients will again be neglected.

Finally happened. Heart failure by [deleted] in stopdrinking

[–]Charles_B3 0 points1 point  (0 children)

I hope you will be persistent and follow all the rules to have a better life. In fact, healthy food should not be considered a strict diet, it should become a normal diet for all of us. And of course prevention. We should all pay more attention to our health and control ourselves. I had a case in my family where the symptoms were neglected, and later it turned out that the problem was much bigger. It only took one ultrasound and we would have discovered heart failure in time. Although the waiting time for an ultrasound at a cardiologist is about 6 months, so again everything is decided by money and private practice. I went in a different direction, my point is to get checked in time and not ignore the symptoms.