Use Jira Cloud in a highly-regulated environment
Best practices and ready-made solutions for achieving total compliance in Jira Cloud for life sciences, healthcare, finance, and other highly regulated industries.
Common obstacles to using Jira Cloud in highly regulated environments:
Steep learning curve
Navigating Jira Cloud’s extensive configuration options is time-consuming and can feel overwhelming.
Hidden compliance gaps
You need to know where Jira’s compliance gaps are and how to close them tightly.
Resistance from QA
Quality assurance stakeholders are often reluctant to accept cloud-based tools and agile development practices.
It doesn’t have to be that way:
Kill the learning curve
Avoid weeks or months of wasted trial-and-error by configuring Jira right the first time.
Close compliance gaps
Make your Jira Cloud site 100% audit-ready by understanding exactly where Jira’s off-the-shelf compliance gaps are and how to close them.
Win over QA
Learn how to address the specific concerns of QA teams and build trust in both Jira Cloud and your agile processes.
I can give you a head start
Hi! I’m Aaron.
Navigating Jira Cloud’s configurations and selecting apps from the Atlassian Marketplace can be overwhelming for any company.
And it feels 10x harder for us in the life sciences, healthcare, finance, and other highly regulated industries.
It doesn’t have to be so hard.
I’ve spent more than 15 years as a software engineer in the life sciences industry. And I’ve helped dozens of companies (including 11 of the world’s largest life science companies) modernize their development processes and toolsets.
But I had to learn everything the hard way. You don’t have to.
I can show you how to build an end-to-end SLDC process completely inside Jira Cloud. It includes proven agile workflows to support your developers, testers, and quality stakeholders. And you’ll be ready to respond to audits with confidence.
Start configuring Jira Cloud for total regulatory compliance:
The Ultimate Guide to Part 11 Compliance in Jira Cloud
The ultimate guide for closing Jira Cloud’s compliance gaps and ensuring your site is audit-ready. Follow step-by-step instructions to configure Jira Cloud to be compliant with 21 CFR Part 11:
- Enhanced audit trails
- User access policies
- Record retention
- Compliant workflows
- Electronic signatures
- Compliant reporting
The Agile Compliance System for Jira
Ensure compliance with 21 CFR Part 11, Part 820, and IEC 62304 using Jira Cloud as your all-in-one agile ALM solution.
- All-in-one solution: Don’t make your users needlessly switch between applications. Use Jira to manage requirements, risks, tests, defects, and backlog items all in one place.
- 100% compliant: Confidently deploy Jira, knowing all compliance gaps are closed, and your system complies with 21 CFR Part 11, Part 820, IEC 62304, ISPE GAMP 5, and more.
- Readymade configurations: Skip the frustration of designing advanced configurations and integrating third-party apps. You’ll start on the right track with best-practice Jira workflows and configurations already built for you.
- Full traceability: Leverage Jira’s powerful linking capability to establish full traceability across your entire ALM solution, making quality audits a breeze.
- Audit-ready documentation: Avoid weeks of extra work using a prewritten validation package, including a validation plan, user requirements, risk assessments, Part 11 trace matrix, and more…all fully compatible with ISPE GAMP 5.
Free Resources
Support your validation effort with my library of free tutorials and downloads:
How to deploy Jira Cloud in a highly regulated environment:
1. Start with best-practice configurations
Use my step-by-step instructions to implement best practice Jira configurations tailored for life sciences and other highly regulated environments.
2. Customize and validate
Tailor the configurations to your company’s specific needs, and then validate your Jira Cloud site using a GAMP 5-compliant validation strategy.
3. Go Live! with confidence
Launch your new Jira Cloud site with confidence, knowing that everything is compliant and optimized for efficient agile development.
Why Jira Cloud?
Affordable
Deploy a compliant SDLC platform while saving up to 90% of the cost vs. a niche toolset.
Configurable
Easily tailor the platform to your organization’s needs with tailored fields, workflows, and automations.
Integrations
Implement a full SDLC entirely in Jira..or connect your favorite tools…you decide!
Audit ready
Confidently demonstrate compliance with government regulations to your internal and external auditors.
Is YOUR Jira site Part 11 compliant?
Download this FREE traceability matrix to find your compliance gaps and learn how to fix them.