SoftComply TW header
 

We hope you and your loved ones are safe during these challenging times!

In our September Newsletter you can read about the latest updates of the new version of the SoftComply eQMS released this week. Besides improving and adding to the content of the SOPs and technical document templates, we have also added a macro that allows you to take control of copying pages from QMS templates so that they will keep their Page History. This is a particularly important feature for regulatory audits.

You can also check out our new video clips on Medical Device Regulations and the MediCompli Solution as well as on establishing risk traceability with the SoftComply Risk Manager in our YouTube channel.

In light of the global Covid-19 crisis & the importance of medical innovations in today's world, we have considerably lowered the prices of the SoftComply Risk Manager on Jira Cloud!!!

***

SoftComply has released a new Confluence Server macro within the SoftComply eQMS app that allows the user to use any Confluence page as a template, copying it automatically into the existing space at a click of a button. Features include the addition of prefixes, suffixes, timestamp and more. This bypasses the use of Confluence templates and their related limitations.

Use Case

From a compliance standpoint, the lack of control of Confluence Templates is a big no-no. Any admin can potentially modify them and there will be no change history to track the updates. In addition, if a company uses any document approval workflow and e-signatures apps such as Comala Document Management, there is an error-prone, manual step to upload the latest version of a template into the respective Confluence Template. Luckily, SoftComply has a solution to overcome this shortage – the "Create Page(s) from Template" macro.

Its only purpose is to provide shortcut to create a Confluence page from any page or page tree. For example. if you have your own meeting notes template and you wish to create a copy of it in a specific place, then just use this “Create Page(s) from Template” button/macro in the SoftComply eQMS app.

Benefits of the new Macro

When you add the new macro to a Confluence page, you can define a number of macro input parameters:

1. Source page – which page you would like to copy. NB: It also can be the parent page of the tree you wish to copy.
2. Destination location – where the source page / tree is copied to. If you do not specify the location, then it is copied as a child page to the page the macro is in.
3. Copy children – if enabled / checked, then you can copy whole page tree. Thus you can even copy whole SPACE.
4. Prefixes and Suffixes – since you cannot have two Confluence pages in one space with the same name, the prefix/suffix will help you to avoid that. You can use them for that exact purpose by adding a timestamp as prefix of suffix to the copied page.
5. Remove labels – if you have labels in the source page but you would like to copy the page without its labels, then this feature can help you. This is also a particularly useful feature in case you are using the Comala workflows app where behavior is driven by the page labels.
1. Source page – which page you would like to copy. NB: It also can be the parent page of the tree you wish to copy.
2. Destination location – where the source page / tree is copied to. If you do not specify the location, then it is copied as a child page to the page the macro is in.
3. Copy children – if enabled / checked, then you can copy whole page tree. Thus you can even copy whole SPACE.
4. Prefixes and Suffixes – since you cannot have two Confluence pages in one space with the same name, the prefix/suffix will help you to avoid that. You can use them for that exact purpose by adding a timestamp as prefix of suffix to the copied page.
5. Remove labels – if you have labels in the source page but you would like to copy the page without its labels, then this feature can help you. This is also a particularly useful feature in case you are using the Comala workflows app where behavior is driven by the page labels.

To learn more about how you can use the new Create Page from Template macro in the SoftComply eQMS, please keep reading.

In case you would like to learn more about the new Create Page from Template macro, please let us know and we'd be happy to demonstrate how it work.

***

Join our webinars and training courses to learn more about Medical Device Regulations, Medical Device Risk Management & implementing an FDA Compliant Quality Management System on Atlassian Stack.

***

In case you cannot join the webinars, feel free to check out the webinar recordings in our YouTube channel about:

▪ Medical Device Regulations & the FDA compliant QMS Solution in Confluence,
▪ Risk Management in Jira with the SoftComply Risk Manager app, and
▪ Establishing Risk Traceability in Jira and Confluence.
Medical Device Regulations & the FDA compliant QMS Solution in Confluence,
Risk Management in Jira with the SoftComply Risk Manager app, and
Establishing Risk Traceability in Jira and Confluence.
***

The MediCompli Solution is the only FDA 21 CFR 11 and MDR compliant Document Management Solution on Atlassian Confluence that provides you with:

▪ Full Quality System documentation (based on FDA 21 CFR 820, ISO 13485, IEC 62304 and ISO 14971);
▪ FDA 21 CFR 11 Compliant Document Approval, Change Request, Training and CAPA workflows;
▪ FDA 21 CFR 11 Compliant Electronic Signatures;
▪ FDA 21 CFR 11 Compliant Access Management.
Full Quality System documentation (based on FDA 21 CFR 820, ISO 13485, IEC 62304 and ISO 14971);
FDA 21 CFR 11 Compliant Document Approval, Change Request, Training and CAPA workflows;
FDA 21 CFR 11 Compliant Electronic Signatures;
FDA 21 CFR 11 Compliant Access Management.

To learn more, please check out the short video clip about the solution, read more about the solution or contact us for an online demo call.

***

This post is about Cibiltech's regulatory compliance journey describing them moving from manual and distributed Document Management System to a Confluence based and FDA compliant Document Management System with the MediCompli Solution.

The journey also illustrates how Cibiltech chose the MediCompli Solution and how the MediCompli Solution compares to other Medical Device Document Management solutions tools out there.

Please continue here to read about Cibiltech's journey.

***

Check out & join our brand new Atlassian Jira online training courses!

***
***

Benefits of the SoftComply Risk Manager PLUS for Jira Server:

▪ Supports Hazard Analysis and FMEA
▪ Supports FMEA with Detectability
▪ Displays risks in Matrices & RPN
▪ Supports FDA approval and CE-marking process
▪ Targeted towards safety critical domain users
Supports Hazard Analysis and FMEA
Supports FMEA with Detectability
Displays risks in Matrices & RPN
Supports FDA approval and CE-marking process
Targeted towards safety critical domain users

For full list of features of SoftComply Risk Manager PLUS, please check out the User Guide. Try it out for free for a month and/or contact us to get a demo & discussion about the features.

***

Benefits of the SoftComply eQMS:

▪ Full Quality Management System for medical device co-s
▪ On ISO13485, IEC62304, ISO14971, FDA 21CFR 820
▪ Fully customizable with embedded guidance
▪ Reduces the cost of compliance
▪ Most competitive price
Full Quality Management System for medical device co-s
On ISO13485, IEC62304, ISO14971, FDA 21CFR 820
Fully customizable with embedded guidance
Reduces the cost of compliance
Most competitive price

SoftComply eQMS on Confluence Cloud:

The new MDR states that Quality System documents need to be searchable. You can now implement a compliant Quality System documentation on your Confluence Cloud! Access the free trial version directly from the Atlassian Marketplace and/or contact us to get a demo & discussion about the content of the product.

***

Benefits of the SoftComply Risk Manager:

▪ Supports any software system/product risk management
▪ For both Jira Server & Cloud users
▪ Fully customizable for any type of risk project
▪ Automated traceability
▪ Support software system/product risk management
▪ Most competitive price
Supports any software system/product risk management
For both Jira Server & Cloud users
Fully customizable for any type of risk project
Automated traceability
Support software system/product risk management
Most competitive price

For full list of features of SoftComply Risk Manager, please check out the User Guide. Try it out for free for a month and/or contact us to get a demo & discussion about the features.

***
 
 
Powered by Mad Mimi®A GoDaddy® company