SoftComply eQMS is a complete Quality Management System based on ISO 13485, IEC 62304, ISO 14971 and 21 CFR 820
SoftComply eQMS is a complete Quality Management System based on ISO 13485, IEC 62304, ISO 14971 and 21 CFR 820
SoftComply eQMS is a complete Quality Management System based on ISO 13485, IEC 62304, ISO 14971 and 21 CFR 820
A Fully Customizable Quality Management System
Embedded Guidance for Customizing Your QMS
Compliant QMS Documents for Each Project
Limited trial view of a Quality Management System for Medical Devices. Based on ISO 13485, IEC 62304 & 21 CFR820, the eQMS fast-tracks the development of organization’s procedures and processes for regulatory compliance.
The SoftComply eQMS comes with a complete “Example QMS” taken from real industry cases. Info-boxes, Warnings and Notes suggest best practices on how to make the best use of your Quality System.
The SoftComply eQMS comes with a number of macros, which will automate some of the most common actions. With a simple interface, these macros will save precious time during the creation of sizeable technical files.
A Fully Customizable Quality Management System
Embedded Guidance for Customizing Your QMS
Compliant QMS Documents for Each Project
A full Quality Management System for Medical Devices. Based on ISO 13485, IEC 62304 & 21 CFR 820, the SoftComply eQMS fast-tracks the development of your organization’s procedures and processes for regulatory compliance.
The SoftComply eQMS comes with a complete “Example QMS” taken from real industry cases. Info-boxes, Warnings and Notes suggest best practices on how to make the best use of your Quality System.
The SoftComply eQMS comes with a number of macros, which will automate some of the most common actions. With a simple interface, these macros will save precious time during the creation of sizeable technical files.
More details
This is a LIMITED TRIAL VIEW of the SoftComply eQMS for Confluence Cloud users.
Based on ISO 13485, IEC 62304 & 21 CFR 820, the SoftComply eQMS fast-tracks the development of organization’s procedures and processes for regulatory compliance - a complete Quality System for medical device companies.
SoftComply eQMS has a Quality Manual, a Quality Policy, 17 SOPs and 50 document templates pre-filled to fast-track the implementation of your QMS.
Fully customizable to any medical device project, containing embedded guidance on how to finalize the SOPs and technical documents.
The SoftComply eQMS includes also a finalized QMS, the “Example eQMS”, based on real industry cases that you can follow to customize the QMS for your company.
The SoftComply eQMS is the fastest path to implementing a compliant Quality System for medical devices. To view all content, contact us.
Purchase directly from SoftComply. Full product pricing here.
For compliant risk management, try also SoftComply Risk Manager.
More details
A full Quality Management System for Medical Devices. Based on ISO 13485, IEC 62304 & 21 CFR 820, the SoftComply eQMS fast-tracks the development of your organization’s procedures and processes for regulatory compliance.
SoftComply eQMS has a Quality Manual, a Quality Policy, 17 SOPs and 45 document templates pre-filled to fast-track the development and implementation of your QMS. Just add your company and product development details!
SoftComply eQMS is fully customizable to any medical device development project. It contains embedded guidance on how to finalize the SOPs and technical documents.
The SoftComply eQMS also includes a complete and finalized QMS, the “Example eQMS”, based on real industry cases. You can follow this example to customize the eQMS for your company.
The SoftComply eQMS provides the fastest path to implementing a compliant Quality Management System for medical devices.
For full regulatory compliance, try our Risk Management app for Jira for device risks.
Reviews for cloud
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Thank you, Chris, for such a positive review! We are delighted to hear that you have found our app useful in implementing your Quality Management System!
- SoftComply Team
Dear Kirsten,
SoftComply eQMS provides the content for a compliant Quality Management System for medical device companies. As such, we cannot provide the full content of the product here. Like the app description under "More Details" highlights: "this is a LIMITED TRIAL VIEW of the SoftComply eQMS for Confluence Cloud users." Unfortunately, there is no other way we could list the SOPs and technical templates that are included in the product. But we do offer an online demo for anyone who wants to see the entire content of the product (as per our email to you a few days ago). Please let us know if you'd like to arrange such a call to learn more about the SoftComply eQMS.
Thanks and kind regards, SoftComply Team
Reviews for server
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Reviews for Data Center
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Cloud Pricing
Server Pricing
Data Center Pricing
| 10 users$1,400 | 25 users$1,500 | 50 users$1,700 | 100 users$1,900 | 250 users$2,100 | 500 & upAdditional pricing details |
Pricing FAQ
- How does server app pricing work?
Server products and apps are hosted on your servers. This app is sold as a perpetual license, and the purchase price includes 12 months of maintenance (support and version updates).
You can renew maintenance after 12 months at 50% of the current purchase price. You can upgrade the tier of your Atlassian product and app licenses at any time. Upgrade prices are calculated based on Atlassian's formula (view example).
If app pricing changes after your initial purchase, there's a 60-day grandfathering period during which you can renew based on the old pricing.
- How do I determine my server pricing?
Apps are billed based on the number of users in your Atlassian product. The app tier should match the licensed user tier of the Atlassian product. For example, if you have a Confluence license for 500 users, you should purchase the 500-user tier for apps. Even if fewer users want to use the app than your Atlassian product license, the two licenses should match exactly.
- Can I install this app in a Data Center product?
This app does not have a Data Center approved version. Only apps meeting a set of performance requirements for large, clustered environments are approved for Data Center.
However, while server apps are built for single-server deployments, many customers successfully install them in Data Center products. If you're using a Data Center product, Atlassian recommends you contact the vendor to determine compatibility at scale.
- What type of license do I need if I'm using this app in a Data Center product?
Because this app does not have a Data Center approved version, you should purchase a Server license if you decide to install this app in a Data Center product.
- Do you offer academic, community, or open-source licenses for server apps?
For server apps, academic licenses are available at a 50% discount if you have an academic license for your Atlassian product.
Community and open-source licenses are available for server apps. Learn more about community and open source licenses.
- Can I extend my free trial?
For server apps, you can extend your app trial up to 5 times - in other words, for up to six months. Extend your trial by generating a new evaluation license key from Atlassian Marketplace. Click Try it free and you'll be directed to generate a new license. Paste this license key into the app listing in UPM from your Atlassian product, and you're all set.
- How can I buy apps for my legacy Jira Server or Confluence Server license?
If you own a legacy Jira Server Unlimited (100+ users) or Confluence Server Unlimited (2000+ users) license purchased in 2012 or earlier, legacy app pricing is no longer available. You have two options for app purchasing:
- Purchase the app at the non-legacy Unlimited (10000+ users) tier.
- Renew your Jira or Confluence license at a non-legacy tier, then purchase the app at the same tier.
SoftComply provides support for this app.
SoftComply provides support for this app.
Vendor support resources
Find out how this app works.
Community discussions connect you to the vendor and other customers who use this app.
Atlassian-hosted discussions connect you to other customers who use this app.
Vendor support resources
Find out how this app works.
Community discussions connect you to the vendor and other customers who use this app.
Atlassian-hosted discussions connect you to other customers who use this app.
Versions
Confluence Cloud • Released 2019-05-01
Summary
Minor version update
Details
Minor version updateVersions
Version 0.6.0 • Confluence Server 5.10.0 - 6.15.4 • Released 2018-04-30
Summary
Improved content
Details
Additional new template and improved example content.
Installation
- Log into your Confluence instance as an admin.
- Click the admin dropdown and choose Atlassian Marketplace. The Manage add-ons screen loads.
- Click Find new apps or Find new add-ons from the left-hand side of the page.
- Locate SoftComply eQMS via search. The appropriate app version appears in the search results.
- Click Try free to begin a new trial or Buy now to purchase a license for SoftComply eQMS. You're prompted to log into MyAtlassian. SoftComply eQMS begins to download.
- Enter your information and click Generate license when redirected to MyAtlassian.
- Click Apply license. If you're using an older version of UPM, you can copy and paste the license into your Confluence instance.
To find older SoftComply eQMS versions compatible with your instance, you can look through our version history page.
- Log into your Confluence instance as an admin.
- Click the admin dropdown and choose Add-ons. The Find new apps or Find new add-ons screen loads.
- Locate SoftComply eQMS.
- Click Install to download and install your app.
- You're all set! Click Close in the Installed and ready to go dialog.
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