Here’s everything.

All my YouTube videos about building compliant Jira workflows in a single playlist.

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This playlist has all my YouTube videos about using Jira Automation to accelerate your regulated workflows.

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A list of my favorite Jira Cloud apps for building a compliant SDLC for regulated industries.

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Learn how to build a simple Jira Cloud workflow suitable for pharmaceuticals, medical devices, and other highly regulated industries.

In four easy lessons, I’ll walk you through converting an off-the-shelf Jira workflow from Atlassian into a fully compliant GxP workflow with: controlled flows, field validation, user permissions, status-based workflow controls, and Part 11 compliant electronic signatures.

>>> Instant access

Learn how to use Atlassian Jira Cloud as a requirements management tool in pharmaceuticals, medical devices, and other highly regulated industries.

In this course, you’ll learn how to build a fully compliant software requirement specification in Jira Cloud, including:

• Creating audit-ready requirement baselines using Confluence or MS Word.
• Supporting multiple requirement types
• Designing requirement traceability
• Building a visual hierarchy of requirements in both Jira and Confluence.

>>> Instant access

The Ultimate Jira Admin Guide for Highly Regulated Industries is the first book built specifically for professionals like you — people responsible for configuring and managing Jira Cloud in life sciences and other highly-regulated industries such as aerospace, finance, or healthcare.

You’ll learn how to:

• ✅ Set up workflow controls, audit trails, and e-signatures that meet 21 CFR Part 11 (EU Annex 11)
• ✅ Lock down your system so that unauthorized changes become impossible
• ✅ Create a validation plan that aligns with ISPE GAMP 5 — and understand exactly what to include (and what to leave out)
• ✅ Keep your system compliant even when Atlassian pushes surprise updates, third-party apps evolve, and your team makes changes on the fly
• ✅ Build a data recovery strategy that goes beyond Jira’s defaults
• ✅ Show your leadership and QA team that your Jira Cloud site isn’t just “good enough” — it’s built to support regulated work with confidence
• ✅ and so much more!!!

>>> Get the guide

Get tailor-made Jira workflows built to fit your real-world processes — without the hassle or endless trial and error.

Through a guided configuration workshop, we’ll uncover your business and compliance needs. Then we’ll build and refine your workflows through an iterative delivery process, so you can provide feedback and request improvements — guaranteeing that you’ll be satisfied with the final result.

Choose from Done With You (DWY) — where I coach you through the setup — or Done For You (DFY) — where I handle everything for you.

Every workflow comes with full technical support and a warranty for complete peace of mind.

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Ensure compliance with 21 CFR Part 11, Part 820, and IEC 62304 using Jira Cloud as your all-in-one agile ALM solution.

• 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.
• 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.

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Accelerate your Jira Cloud implementation with agile best practices that meet regulatory expectations. This consulting service is designed specifically for teams working under AAMI TIR45, IEC 62304, or ISPE GAMP 5, and includes:

• ✅ Expert configuration of Jira for requirements management, backlog management, defect management, and more
• 🧾 Tailored reporting templates to meet your audit and traceability needs
• 🧠 Technical training for both Jira admins and end users

Whether you’re just getting started or need help optimizing an existing setup, I’ll help you streamline your SDLC processes without sacrificing compliance.

>>> Apply now

A detailed, line-by-line analysis of 21 CFR Part 11 as it relates to Jira Cloud.

>>> Download now

Ensure compliance with 21 CFR Part 11, Part 820, and IEC 62304 using Jira Cloud as your all-in-one agile ALM solution.

• 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.
• 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.

>>> Learn more

All my YouTube videos about agile requirements management.

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A 90-day program for new teams that want to get started on the right foot. Use my turnkey processes to get up and running as fast as possible while ensuring you’ll be compliant and audit-ready.

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A 120-day program for established teams that want to transition from traditional to agile processes. Use my framework to assess your current agility level and create a personalized path to a successful agile transformation.

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A 180-day program for already-agile teams that want to improve their performance. Use my framework to create more predictable release schedules, higher software quality, and enhanced audit readiness.

>>> Apply now