256
Customers have installed this app in at least 256 active instances.
256
Customers have installed this app in at least 256 active instances.
    by SoftComplyfor Confluence Cloud, Confluence Server 6.0.1 - 7.5.2 and more versions
    Versions available for Confluence Server 5.9.2 - 5.10.9
    Supported
    SoftComply supports this app.

    Get support

    Supported
    SoftComply supports this app.

    Get support

    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 ISO13485, IEC62304 & 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.

    Includes a Quality Manual, a Quality Policy, 20 SOPs & 55 document templates pre-filled to fast-track the implementation of QMS.

    Fully customizable, contains embedded guidance on finalizing the SOPs and technical documents as it includes a finalized QMS based on real industry cases.

    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 a FDA 21 CFR 11 compliant QMS solution with document control, please see MediCompli solution.

    Try the SoftComply Risk Manager for device risks.

    Join our free webinars to learn more about our Atlassian apps!

    More details

    A full Quality Management System for Medical Devices - based on ISO13485, IEC62304 & FDA 21 CFR820, the SoftComply eQMS fast-tracks the development of your organization’s procedures and processes for regulatory compliance.

    Includes a Quality Manual, a Quality Policy, 20 SOPs and 55 document templates pre-filled to fast-track the implementation of QMS.

    Fully customizable, contains embedded guidance on finalizing 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 a FDA 21 CFR 11 compliant QMS solution with document control, please see MediCompli solution.

    For full regulatory compliance, try the Risk Management app on Jira for device risks.

    Join our free webinarsto learn more about our Atlassian apps!

    Reviews for cloud

    (4)
    Sign in to write a review
    by David Coleman on 2020-03-06
    SoftComply eQMS is a great eQMS that faciliates our company to produce medical-grade software (ISO 13485). We spent quite abit of time accessing other QMS tools; alot of them were either very expensive, cumbersome to use or difficult to integrate with our software development process which would affect our ability to scale. SoftComply eQMS is very easy to use, is Confluence-based which is great as most of developers are familiar with it and provides very good foundation to build a QMS. SoftComply team have been very helpful with any queries we've had (lots of them!) and have provide great support. The trial version provides screenshots of the products only, we got a good idea on how the product works once we got a live demo of the product.
    Was this review helpful?YesNo
    by Chris Nicholls on 2019-04-02
    We are now using eQMS on cloud, to create a QMS system that is compliant with ISO13485 (Medical Devices) and have found it extremely useful. We did speak to the SoftComply team, to have a demonstration prior to purchasing the content, (which consists of a number of templates and examples for how to use the templates.). They were all very helpful and have continued to check in with us to make sure that all is going well. They have also been on hand to answer any questions we may have and have always responded promptly (allowing for the time difference of us being in Australia). Basically the team is a pleasure to work with! I have also found that "Approvals for Confluence" (available on the marketplace) seems to work well with SoftComply's eQMS to allow team members and managers to approve pages (SOPs etc) created in confluence for cloud.
    2 out of 3 found this review helpful
    Was this review helpful?YesNo
    SoftComply

    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

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    Cloud Pricing

    Server Pricing

    Data Center Pricing

    10 users$2,40025 users$2,50050 users$2,700100 users$2,900250 users$3,100500 & 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.

    Learn more about Data Center approved apps

    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.

    Learn more about Data Center licensing

    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.

    Learn more

    SoftComply provides support for this app.

    SoftComply provides support for this app.

    Vendor support resources

    Documentation

    Find out how this app works.

    Community

    Community discussions connect you to the vendor and other customers who use this app.

    See existing Q&A in Atlassian CommunityAsk a question in the Atlassian Community

    Atlassian-hosted discussions connect you to other customers who use this app.

    Vendor support resources

    Documentation

    Find out how this app works.

    Community

    Community discussions connect you to the vendor and other customers who use this app.

    See existing Q&A in Atlassian CommunityAsk a question in the Atlassian Community

    Atlassian-hosted discussions connect you to other customers who use this app.

    Versions

    Confluence Cloud Released 2020-02-18

    Summary

    Minor version update

    Details

    Minor version update

    Versions

    Version 1.2.0 Confluence Server 6.0.1 - 7.5.2 Released 2020-05-27

    Summary

    New and improved content (SOPs and templates)

    Details

  • Rationalization of CAPA SOP and Change Management SOP. Addition of workflow diagram.
  • Addition of references to the new SOPs in the Device Lifecycle SOP.
  • Feedback, Complaints and PMS SOP: clarification on management of returned product and expansion of section on PMS activities.
  • Management review SOP: addition of reference to NC process and addition of Analysis section.
  • Manufacturing SOP: Addition of Traceability section.
  • Purchasing and Supplier Management SOP: clarification on incoming activities and customer product. Reference to NC process. Addition of sections on Changes to purchased products and Change Agreements. Section on supplier monitoring expanded.
  • Resource Management SOP: Addition of section on Competences. Calibration failure to trigger an NC and not a CAPA.
  • Risk Management SOP: Addition of section of probability of sw failure. Addition of standards to Cybersecurity section.
  • New SOPs: Labeling and UDI SOP, Non-Conformities SOP, Distribution, Installation and Servicing SOP
  • Installation

    1. Log into your Confluence instance as an admin.
    2. Click the admin dropdown and choose Atlassian Marketplace. The Manage add-ons screen loads.
    3. Click Find new apps or Find new add-ons from the left-hand side of the page.
    4. Locate SoftComply eQMS via search. The appropriate app version appears in the search results.
    5. 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.
    6. Enter your information and click Generate license when redirected to MyAtlassian.
    7. 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.

    1. Log into your Confluence instance as an admin.
    2. Click the admin dropdown and choose Add-ons. The Find new apps or Find new add-ons screen loads.
    3. Locate SoftComply eQMS.
    4. Click Install to download and install your app.
    5. You're all set! Click Close in the Installed and ready to go dialog.

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