Configure and validate Jira Cloud for highly regulated environments.

Prebuilt Configurations

Implement GxP-compliant Jira setups, including Part 11 compliance and electronic signatures.

Best-Practice Workflows

Start with proven agile workflows for your stories, requirements, tests, runs, defects, and more.

One-on-One Support

Benefit from personal guidance on SaaS validation strategies, Jira configuration capabilities, and agile best practices.

1. Start with ready-to-use configurations.

We’ll rapidly set up your Jira Cloud instance using our GxP-compliant configurations.

2. Tailor to your needs and validate.

Together, we’ll tailor the configurations to your specific needs and complete the validation process using my pre-built validation package.

3. Go Live! with confidence.

Launch your new Jira Cloud site with confidence, knowing that everything is compliant and optimized for efficient agile development.

1. Readymade Jira Configurations: Accelerate your setup time while having confidence that there are no compliance gaps during future audits.
2. Best Practice Agile Workflows: Ensure your Jira workflows are usable for developers and accepted by regulatory auditors.
3. GAMP 5-compliant Validation Plan: Eliminate guesswork in planning a SaaS-based validation and enjoy quicker quality approvals and smoother audits.
4. Validation Deliverables Checklist: Prevent critical validation steps from being missed and avoid potential compliance issues down the line.
5. Validation Schedule Template: Manage your validation effort effectively to achieve timely completion of validation tasks and faster time-to-market.
6. High-level Risk Assessment: Implement early risk mitigation strategies to reduce the likelihood of compliance failures and enhance overall project success.
7. Vendor Risk Assessments: Ensure you’ve selected the right vendor and have confidence that your validated system is supported by capable third parties.
8. Part 11 Trace Matrix: Ensure all requirements of 21 CFR Part 11 are satisfied and ensure there are no hidden compliance gaps waiting to be exposed by an auditor.
9. User Requirement Specification: Start with a complete requirement specification to fully document and validate the system’s intended use.
10. Functional Executable Specification: Use a Gherkin-formatted (BDD) functional specification for a clear and testable understanding of the system’s expected functionality.
11. Configuration Specification: Easily understand and maintain your Jira configurations with a detailed configuration specification.
12. One-on-One Consulting: Meet with me weekly to address and eliminate validation project speed bumps and keep your validation project on track. (For 90 days / 13 weeks)
13. Technical Support by Email: Receive fast, expert support for troubleshooting Jira configurations to avoid delays and resolve issues promptly.

Plus all these bonuses:

• Automated Deployment of Readymade Configurations: Accelerate your setup even more using an automated deployment of my baseline configurations, saving serious time and ensuring consistent and error-free configurations.
• Readymade Work Instructions for Users: Enhance user adoption and reduce training time.
• Live Training: Jira Configuration Management: Learn how to maintain your validated system after Go Live through compliant management of Jira configurations.
• Live Training: Jira Workflow Configurations: Learn how to tailor and maintain your new Jira workflows, even if you’ve never configured a Jira workflow before.
• Live Training: Using Confluence as a QMS: Learn how you can seamlessly integrate Confluence Cloud with Jira Cloud to create compliant QMS for your Jira data.
• Live Training: Agile Compliance in Highly Regulated Environments: Learn the keys to aligning agile practices with regulatory expectations in accordance with AAMI TIR 45.
• Live Training: Agile Requirements Management for Highly Regulated Environments: Learn how to compliantly manage your product requirements inside an agile workflow.
• Live Training: Agile Development for Highly Regulated Environments: Take a deep dive into the best practices for managing development tasks in a highly regulated environment.
• Live Training: Agile Test Management for Highly Regulated Environments: Learn how to use Xray for Jira to compliantly manage your agile testing activities.
• Live Training: Agile Planning for Highly Regulated Environments: Learn how to plan agile software releases and maintain an agile backlog where regulatory compliance is concerned.
• Live Training: Agile Release Management for Highly Regulated Environments: Learn how to leverage Jira to ensure your software releases are compliant and audit-ready for the long term.
• Live Training: Agile Risk Management for Highly Regulated Environments: Learn how to manage your product and system risks directly in Jira and build risk management into your agile workflows.

1. The right way to validate a cloud application like Jira Cloud.

First, we’ll discuss the only compliant strategy for validating a cloud-based (SaaS) application based on GAMP 5 (Second Edition).

2. Everything you’ll get with Jira Validation Accelerator and whether it’s right for you.

Next, we’ll review everything you get inside Jira Validation Accelerator…all the prebuilt configurations, readymade deliverables, and additional support and training. Then we’ll do an honest assessment of whether the package is a good fit for you and your organization.

3. How much Jira Validation Accelerator costs.

Finally, we’ll discuss how much Jira Validation Accelerator costs. (Less than you expect!) And I’ll show the cost is almost insignificant compared to the amount of time it will save you.