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If you’ve ever tried to implement agile in a regulated environment—especially in medtech—you probably hit an extremely common roadblock. In this quick ~5-minute video, I answer a great question from a recent webinar:
👉 “What do you think is the hardest part of an organization to change in an agile transformation in a medical device context?”

I’ll break down the two biggest mindset shifts your team needs to make, and where most agile transformations fail. (Hint: It’s not in the tooling.)

🎥Related Videos:
- Embracing "Done is Done", or the secret to agile compliance: https://youtu.be/9g0QPI0YAng
- Agile backlog vs. requirements specification: What's the difference? https://youtu.be/f9igxefwufA

🎬Webinar: Here's a link to the webinar replay about Agile Risk Management, where this question was asked: https://youtu.be/bnFCNT0dDRQ?si=OZ5xY1E6Pr_ubHwu

00:00 Intro
00:42 Done is Done
02:22 Agile Requirements Management
05:19 Outro

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Fully Automate Confluence Cloud Backups with AWS | Step-by-Step Tutorial for Regulated Environments

Want to automate your Confluence Cloud site backups and store them securely in AWS? In this hands-on tutorial, you'll learn how to:
✅ Automatically trigger Confluence Cloud backups on a custom schedule
✅ Download backup files to AWS S3 for secure storage
✅ Set up email notifications to alert you of any failures

This is video #2 in my Back-up & Recovery Series for Atlassian Cloud. Watch the entire series here:
https://www.youtube.com/playlist?list=PL3v013BFZZmHB7_5J55s1QVc647fIaFWC

Ideal for IT teams in regulated industries like pharma, biotech, and medtech, this video walks through every step:
1. Create manual backups in Confluence Cloud
2. Store your API token and email securely in AWS Secrets Manager
3. Use AWS Lambda to trigger and download backups
4. Set up recurring backups with AWS EventBridge
5. Store backups securely in AWS S3
6. Monitor the process with CloudWatch logs and alarms

⬇️Download the Python scripts used in this video from GitHub:
https://github.com/agile-innovations-tech/atlassian-cloud-backups/tree/main/packages

👉 Learn more about backing up Atlassian Cloud in regulated environments:
https://www.agile-innovations.tech

#ConfluenceCloud #AWS #ConfluenceBackup #Atlassian #RegulatedIndustries

00:00 Intro
00:29 The Backup Process
02:48 Storing credentials in Secrets Manager
03:42 Create a bucket in S3 for storage
05:56 Automating backup creation w/ AWS Lambda
09:06 Grant permissions for backup creation
10:12 Testing backup creation
10:53 Schedule backup creation
13:42 Automating storage of backups
16:06 Grant permissions for backup storage
17:34 Testing backup storage
18:20 Scheduling backup storage
20:11 Configure email alerts
24:52 Outro

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Fully Automate Jira Cloud Backups with AWS | Step-by-Step Tutorial for Regulated Environments

Want to automate your Jira Cloud site backups using AWS? In this step-by-step tutorial, you'll learn how to:
✅ Trigger routine Jira Cloud backups automatically
✅ Store backup files securely in AWS S3
✅ Set up email alerts for backup failures

Perfect for IT teams working in regulated industries like pharma, biotech, or medtech. This video walks you through every step:
1. Securely store your Jira API credentials in AWS Secrets Manager
2. Securely store your Jira Cloud backup files in AWS S3.
3. Set a retention policy on your backup files in S3.
4. Fully automate the backup process using AWS Lambda functions.
5. Design an automated backup schedule using AWS EventBridge.
6. Receive email alerts about backup failures using AWS CloudWatch.

⬇️Download the two Python scripts used in this video from GitHub:
https://github.com/agile-innovations-tech/atlassian-cloud-backups/tree/main/packages

👉 Learn more about using Jira Cloud in regulated environments:
https://www.agile-innovations.tech

#JiraCloud #AWS #JiraBackup #Atlassian

00:00 Intro
00:13 The Backup Process
02:22 AWS Prerequisites
02:37 Storing credentials in Secrets Manager
04:45 Create a bucket in S3 for storage
06:53 Automating backup creation w/ AWS Lambda
09:13 Grant permissions for backup creation
10:10 Testing backup creation
10:52 Schedule backup creation
13:42 Automating storage of backups
15:22 Grant permissions for backup storage
16:28 Configure timeout values
17:46 Testing backup storage
18:25 Scheduling backup storage
19:43 Configure email alerts
24:03 Outro

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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

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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

30 1

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

31 1

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

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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

13 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

17 7

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

52 9

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

89 39

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

8 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

24 4

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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