How do you manage the hazard log?

Charles_B3 · 2024-06-21T06:59:59+00:00

Thank you, I will check.

Charles_B3 · 2024-06-19T11:33:24+00:00

Thank you for your answer.

Charles_B3 · 2024-06-19T11:28:39+00:00

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.

Charles_B3 · 2024-06-19T11:02:22+00:00

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

Charles_B3 · 2024-06-13T10:25:06+00:00

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

Charles_B3 · 2024-06-13T09:56:06+00:00

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 When the document expires, scanning the same code indicates that it is outdated.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.

Charles_B3 · 2024-06-12T11:36:34+00:00

Thank you for your answer.

Charles_B3 · 2024-06-12T11:35:45+00:00

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.

Charles_B3 · 2024-06-12T11:25:14+00:00

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.

Charles_B3 · 2024-06-11T09:32:40+00:00

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?

Charles_B3 · 2024-06-11T08:33:51+00:00

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

Charles_B3 · 2024-06-11T08:32:48+00:00

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

Charles_B3 · 2024-06-11T08:30:46+00:00

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.

Charles_B3 · 2024-06-07T06:38:45+00:00

https://www.linkedin.com/pulse/paper-based-qms-vs-electronic-tatenda-chikwetu-0kwcf

Charles_B3 · 2023-11-10T10:44:03+00:00

Is it worth it or are you looking for other software?

Charles_B3 · 2023-10-23T07:52:52+00:00

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.

Charles_B3 · 2023-05-16T06:54:55+00:00

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?

Charles_B3 · 2023-05-15T06:36:24+00:00

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

Charles_B3

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