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Get started with risk-based testing in Xray for Jira Cloud. Learn how to configure a GAMP 5 risk assessment and use it to transform your test management strategy.

🔍 What you'll learn:

- A brief intro to risk-based testing
- Configure a GAMP 5 risk assessment using custom fields and Jira automation
- Use line-item risk assessments on your requirements and/or risk hazards
- Prioritize testing efforts using risk ratings
- Filter a test coverage report based on risk

For a more detailed description of risk assessment options and configuration, check out my previous video: https://youtu.be/9xkTE-OW5-g.

Learn more about agile development in regulated industries at visit www.agile-innovations.tech.

00:00 Intro
00:16 What is risk-based testing?
00:51 Configuring a risk assessment
01:16 Example: using Jira automation
05:19 Using risk ratings
06:33 Risk-based reporting
07:18 Summary

#jiracloud #xray #riskmanagement

9 2

Are you curious about how to manage risk directly in Jira Cloud? In this video, I review the top 3 solutions for effective risk management in Jira.

📌 In this video, we'll cover:

- The popular third-party app Risk Register by Project Balm.
- The advanced Risk Manager Plus from SoftComply, tailored for regulated industries.
- Using Jira's native automation for custom risk assessments.

Whether you're in the life sciences industry or just searching for an efficient, user-friendly risk management tool, this video is for you. Learn about the strengths, limitations, and best-use cases for each solution.

Marketplace listings:
- Risk Register: https://marketplace.atlassian.com/apps/1213146/risk-register?hosting=cloud&tab=overview
- Risk Manager Plus: https://marketplace.atlassian.com/apps/1219692/softcomply-risk-manager-plus-for-advanced-risk-managers?hosting=cloud&tab=overview

🌐 To learn more, check out my website: www.agile-innovations.tech.

00:00 Intro
00:39 Option 1: Risk Register
04:34 Option 2: Risk Manager Plus
09:37 Option 3: Jira Automation
14:37 Summary

#jiracloud #riskmanagement #lifescience

16 0

Managing requirements in Jira Cloud offers an array of advantages, but organizing your requirements in Jira can be a nightmare. So what if you could seamlessly publish and synchronize your requirements into Confluence for much better organization? In this video, I'll demonstrate how I use the Elements Publish app to build an organized requirement spec in Confluence using requirements stored in Jira.

What You'll Learn:
- An introduction to the Elements Publish app
- Step-by-step guidance on building a tree-like requirements spec in Confluence.
- The advantages and pitfalls of maintaining a hierarchical spec in Confluence
- Strategies to maintain baselines for releases

Elements Publish Website:
https://elements-apps.com/app/publish-to-confluence/

Atlassian Marketplace:
https://marketplace.atlassian.com/apps/1225519/elements-publish-create-confluence-pages-from-jira-issues?tab=overview&hosting=cloud

Find more videos at https://www.agile-innovations.tech/videos

#jiracloud #confluence #requirements #lifescience

00:00 Intro
00:25 Intro to the Elements Publish app
02:00 Example requirement in Jira
02:47 Publishing a requirement to Confluence
04:13 Building a hierarchical spec
05:06 Keeping Jira & Confluence in-sync
06:22 The disadvantage of a hierarchical spec
06:51 Maintaining baselines for releases
08:28 Outro

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Unsure of how to organize your tests in the X-ray for Jira Cloud app? You're not alone. In this video, I explain the difference between repositories, test sets, and test plans in Xray. And I share a glimpse into how I prefer using them in regulated testing.

Learn more at: www.agile-innovations.tech

#Jira #Xray #Testing #SoftwareTesting #agile

00:00 Intro
00:25 The test repository
02:10 Test sets
03:41 Using the test repository with test sets
04:24 Test plans
09:12 Outro

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Many agile teams tend to add too many bugs to their backlog. And, of course, this makes the backlog too hard to manage.

But not to worry, there's an easier way. In this video, I'll share the smart way to manage bugs to improve software quality, minimize the number of defects in your backlog, and make reporting on known issues a breeze.

Learn more at: www.agile-innovations.tech

#agile #jiracloud #workflows #bugs

00:00 Intro
00:27 In-sprint vs. out-of-sprint
01:02 Out-of-sprint bugs
02:05 Using subtasks
03:23 Bug triage
04:24 Reporting known issues
05:15 Outro

8 0

Formal approvals are often the biggest bottleneck in any regulated development process. For starters, many approvals require a Part 11 compliant signature which most development and testing systems do not provide natively. And this means we often need to spend time manually generating PDFs that can be exported to another system for approval.

So how do we speed this up? Well, if you're using Jira, you can install a Part 11-compliant signature app and approve your Jira records right where they are.

In this video, I'll share my favorite signature app for Jira: eSign Electronic Signatures by Digital Rose.

eSign Website:
https://www.digitalrose.dev/esign-for-jira

Atlassian Marketplace:
https://marketplace.atlassian.com/apps/1221581/esign-electronic-signatures-for-jira?tab=overview&hosting=cloud

Part 11 Assessment:
https://digitalrose.atlassian.net/wiki/spaces/ESIGN/pages/12550168/US+FDA+Part+11+Electronic+Signature+Assessment

Learn more at: www.agile-innovations.tech

#electronicsignature #jiracloud #lifescience

00:00 Intro
00:38 Part 11 Assessment
00:44 Issue Types
01:16 Assign Approvers
01:41 Automatically Assign Approvers
02:27 Notifications
02:51 JQL Integration
03:44 Executing a Signature
04:36 Auto-transition to 'Approved'
05:09 PDF Archival
06:02 Outro

5 0

Unstructured testing is possibly the most effective way to both find bugs and validate your requirements. I'm talking about ad-hoc testing, exploratory testing, alpha testing, and beta testing.

But as valuable as they are, we don't spend much time talking about them when planning our V&V. The reason is that they can be hard to document and summarize.

But the good news is there's a great app that integrates with Jira, making it easy to plan, document, and trace your unstructured test activities. That app is the Exploratory Testing App by Xray.

Xray Exploratory Testing App website:
https://www.getxray.app/exploratory-testing

User Guide and docs
https://docs.getxray.app/display/XEA/About+Xray+Exploratory+App

Learn more at: www.agile-innovations.tech

#testing #validation #jiracloud #gxp #lifesciences #lifescience #jira

00:00 Intro
00:40 Download and installation
01:16 Connecting with Jira
02:24 Launching the app
02:59 Creating a test charter
04:51 Starting a test session
06:14 Recording test results
08:23 Ending a test session
08:42 Linking Jira defects
09:29 Viewing test results in Jira
10:09 Tracing to requirements
10:42 Outro

7 0

Jira Cloud's audit history has one gap that can hurt audit readiness...auditing deleted issues. As robust as it is, issue deletion is the one critical event that's simply not captured in Jira's audit log. But the good news is that this gap can be fixed with an affordable third-party app called Issue History for Jira.

Issue History for Jira Website:
https://saasjet.com/issue-history/

Marketplace Listing:
https://marketplace.atlassian.com/apps/1220385/issue-history?hosting=cloud&tab=overview

By the way..."Issue History for Jira" is one of my recommended apps for 21 CFR Part 11 Compliance in Jira Cloud:
https://www.agile-innovations.tech/part-11

#compliance #reporting #jiracloud #gxp #lifesciences #lifescience #jira

00:00 Intro
00:25 Pricing/Installation
00:44 Auditing deleted issues
02:00 Change auditing
02:53 Limitations
04:30 Outro

2 2

Maintaining a requirements spec while working from an agile backlog can be confusing. When should you update your requirements? When should you lock them? And when are they ready for formal testing?

In this video, I answer these questions and a few more about maintaining your requirement specification in agile workflow.

Find more tutorials about using Jira in life sciences:
https://www.agile-innovations.tech

#jiracloud #requirements #lifescience

00:00 Intro
00:35 When is "just in time"?
01:23 Embrace changing requirements
01:57 When to lock requirements?
02:33 When to do formal verification?
02:44 Closing the backlog item
04:06 Snapshotting the specification
04:48 Outro

6 0

The 'Resolution' field is one of the most important fields in Jira. It provides valuable metrics about your software, and Jira uses it to determine whether an issue is resolved (i.e. crossed-out and removed from your backlog). In this video, I share five (5) best practices for managing 'Resolution' in your Jira Cloud workflows, so that both your backlog and reporting are as accurate as possible.

View a transcript of this video:
https://www.agile-innovations.tech/blog/5-tips-for-managing-jira-resolution-field

Find more tutorials about designing Jira Cloud workflows in life sciences:
https://www.agile-innovations.tech/blog?tag=jira-workflows

Contents:
00:00 Introduction
00:48 Tip 1 - Automatically set the Resolution on approval
01:43 Tip 2 - Prompt the user on cancellation
03:00 Tip 3 - Prompt the user when closing a defect
04:20 Tip 4 - Filter the resolution reasons
06:04 Tip 5 - Clear the Resolution when re-opening
06:52 Outro

#jiracloud #jiraadmin #workflows #reporting

4 0

In this tutorial, you’ll learn how to use Jira Automation to build a review cycle into your Jira Cloud workflows, so that you can implement a compliant review process without the overhead of third-party apps and electronic signatures. You’ll find this feature helpful for bug triage, design reviews, and anywhere else an audit-ready review process required.

The steps described in this video are listed here: https://www.agile-innovations.tech/blog/building-a-review-process-with-jira-automation

If you found this video helpful, be certain to checkout my 21 CFR Part 11 Compliance Quick Start Guide for Jira Cloud. https://www.agile-innovations.tech/part-11

Related episodes:
- Creating workflow-based approvals with Jira Automation: https://www.agile-innovations.tech/blog/workflow-based-approvals-with-jira-automation

#jiracloud #jiraautomation #electronicapprovals #gxp #lifesciences #lifescience #jiraadmin #designreview #jira

Contents:
00:00 - Intro
00:16 - Demo
03:04 - Audit Readiness
03:43 - Configure User Groups
04:18 - Configure Custom Fields
04:53 - Configure Comments Screen
05:12 - Configure Jira Workflow
07:14 - Configure Jira Automation
08:00 - Rule #1 - Notify Reviewers
09:21 - Rule #2 - Set Business Reviewer
11:41 - Rule #3 - Set Technical Reviewer
12:28 - Rule #4 - Clear Reviewers
14:09 - Outro

10 6

In this tutorial, you'll learn how to use Jira Automation to create workflow-based approvals, so that you can capture audit-ready approvals, without the overhead of electronic signatures. This can be especially helpful for implementing approvals on intermediate workflow steps prior to the final closure (w/ signatures) of an item.

Disclaimer: This strategy is not intended to replace electronic signatures in all scenarios. Electronic signatures are explicitly required by regulation on some types of records. (For example, design records maintained under 21 CFR Part 820.)

The steps described in this video are listed here: https://www.agile-innovations.tech/blog/workflow-based-approvals-with-jira-automation

If you found this video helpful, be certain to checkout my 21 CFR Part 11 Compliance Quick Start Guide for Jira Cloud. https://www.agile-innovations.tech/part-11

Related episodes:
- Locking Issues by Workflow Status in Jira Cloud: https://www.agile-innovations.tech/blog/locking-issues-by-workflow-status-in-jira-cloud
- Using Jira Cloud Workflow Properties in a Regulated Workflow: https://www.agile-innovations.tech/blog/using-jira-cloud-workflow-properties

#jiracloud #jiraautomation #electronicapprovals #gxp #lifesciences #lifescience #jiraadmin #compliance #jira

Contents:
00:00 - Introduction
00:14 - Demo
00:41 - Audit Readiness
02:38 - Configurations - Custom Fields
03:16 - Configurations - Workflow
04:02 - Configurations - Automation
04:22 - Automation Rule #1
05:24 - Automation Rule #2
06:37 - Wrap-up

27 2

In this tutorial, we look at using Jira Permission Schemes to restrict project access in Jira Cloud. This can be an important step in establishing Jira as a closed system in a regulated environment (such as for 21 CFR Part 11 in life sciences).

If you found this video helpful, be certain to checkout my 21 CFR Part 11 Compliance Quick Start Guide for Jira Cloud. https://www.agile-innovations.tech/part-11

The steps described in this video are listed here: https://www.agile-innovations.tech/blog/using-permission-schemes

Related episodes:
- Locking Issues by Workflow Status in Jira Cloud: https://www.agile-innovations.tech/blog/locking-issues-by-workflow-status-in-jira-cloud
- Using Jira Cloud Workflow Properties in a Regulated Workflow: https://www.agile-innovations.tech/blog/using-jira-cloud-workflow-properties

#jiracloud #gxp #part11 #lifesciences #lifescience #jiraadmin #compliance #jira

52 19

When a workflow status in Jira Cloud is made to be read-only, all fields are locked by default. Use the trick in this video to allow users to edit some fields, while all other fields remain locked.

For example, you might want to allow:
- project admins to update the Fix Versions field on a closed record
- quality reviewers to complete a compliance assessment during a review cycle
- service agents to update fields of a help desk ticket during specific stages of the workflow

If you found this video helpful, be certain to checkout my 21 CFR Part 11 Compliance Quick Start Guide for Jira Cloud. https://www.agile-innovations.tech/part-11

The steps described in this video are listed here: https://www.agile-innovations.tech/blog/making-some-fields-editable

View the Atlassian enhancement request here to check on the current status, and to give it a vote: https://jira.atlassian.com/browse/JSWCLOUD-22084

#jiracloud #gxp #lifesciences #lifescience #jiraadmin #compliance #part11 #jira

4 5

Learn how to restrict actions--such as deleting, moving, cloning, and editing--in Jira Cloud based on workflow status. This is an important strategy for creating compliance in a regulated workflow (GxP, 21 CFR Part 11, SOX, etc.).

If you found this video helpful, be certain to checkout my 21 CFR Part 11 Compliance Quick Start Guide for Jira Cloud. https://www.agile-innovations.tech/part-11

The steps described in this video are listed here here: https://www.agile-innovations.tech/blog/using-jira-cloud-workflow-properties

For copy/paste convenience, here's a summary of the workflow properties referenced in the video:
jira.permission.delete.denied
jira.permission.move.denied
jira.permission.createclone.denied

All the other properties are described here: https://www.agile-innovations.tech/blog/locking-issues-by-workflow-status-in-jira-cloud

Learn more about Jira workflow properties here: https://support.atlassian.com/jira-cloud-administration/docs/use-workflow-properties/

#jiracloud #gxp #part11 #lifescience #lifesciences #jiraadmin #compliance #jira

16 2

Learn how to lock issues (records) in Jira Cloud by restricting field edits, attachments, and comments based on workflow status. This is one of the most common compliance controls for regulated workflows (GxP, 21 CFR Part 11, SOX, etc.).

If you found this video helpful, be certain to checkout my 21 CFR Part 11 Compliance Quick Start Guide for Jira Cloud. https://www.agile-innovations.tech/part-11

The steps described in this video are listed here: https://www.agile-innovations.tech/blog/locking-issues-by-workflow-status-in-jira-cloud

For copy/paste convenience, here's a summary of the workflow properties referenced in the video:
jira.permission.attach.projectrole = 10003
jira.permission.attachdeleteall.denied
jira.permission.attachdeleteown.denied
jira.permission.comment.projectrole = 10003
jira.permission.commentdeleteall.denied
jira.permission.commentdeleteown.denied
jira.permission.commenteditall.denied
jira.permission.commenteditown.denied
jira.permission.edit.projectrole = 10003

Learn more about Jira workflow properties here: https://support.atlassian.com/jira-cloud-administration/docs/use-workflow-properties/

#jiracloud #gxp #part11 #lifescience #lifesciences #jiraadmin #compliance #jira

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