QMS Software

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How To Create a QMS in Sharepoint: Complete Guide + Don't Do It

Anonymous

updated 7 months ago

We’re already using Microsoft software for our company, like Teams and Office. Now need to set up a Quality Management System (QMS) for our medical device which must comply with ISO 13485. We want to

Accepted answer

Don’t do it. Setting up a QMS in Sharepoint is probably the worst thing which could happen to you and your company. It will make your life a living he

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What's The Best QMS Software?

Anonymous

updated 9 months ago

We're looking for QMS software and don't know which one to choose. Which one is the best QMS software?y

Accepted answer

If you're a startup and don't know much about regulatory compliance yet, postpone that decision for now and learn a bit more about regulatory complian

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Can We Integrate Our eQMS With Jira, GitHub, Sharepoint, etc.?

Anonymous

updated about 1 year ago

We'd like to integrate our eQMS with our development tools like e.g. Jira, GitHub, Sharepoint and others. Does that make sense and how should we set it up?

Accepted answer

Don't do it, it doesn't make sense. Long Answer You're probably looking at eQMS software right now and are wondering which one of them integrates wel

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Which QMS Software Should We Choose?

Anonymous

updated about 1 year ago

We're a startup developing software as a medical device and we're wondering which QMS software to choose. They all seem so similar.

Accepted answer

If you don't have any prior regulatory experience: Don't look for QMS software right now. Instead, learn more about what you need to do (read articles

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How Can We Set Up a QMS in Confluence / Jira?

Anonymous

updated about 1 year ago

We’re already using Confluence and Jira for our development planning. Now we need to set up a Quality Management System (QMS) for medical device compliance (e.g. ISO 13485). Can we set up that QMS in

Accepted answer

Don’t do it. Jira sucks, and Confluence sucks, too. I don’t see how any rational human could choose these tools for daily use unless being blackmailed

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QMS Software And Jira / GitHub / GitLab Integrations: Don't Make a Mistake!

Anonymous

updated about 1 year ago

We’re looking for QMS software. It’s important for us that it has a Jira / GitHub / GitLab integration because our development and project planning happens in one of those tools. We want to re-use as

Accepted answer

What you’re looking for doesn’t exist. Even if you had a perfect QMS software with a perfect Jira / GitHub integration, it wouldn’t help you very much

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What Is "FDA 21 CFR Part 820" Compliant eQMS Software?

Anonymous

updated about 1 year ago

We are a startup and are in the early stages of getting our medical device FDA approved. We are currently looking at eQMS software to manage our QMS process. We have to adhere to the “FDA 21 CFR Part

Accepted answer

There’s no such thing as “21 CFR Part 820” compliance or certification. Only the content matters - i.e., the documents you create. You could create th