The Agile Compliance System for Jira in life science companies.
Ensure compliance with 21 CFR Part 11, Part 820, and IEC 62304 using Jira Cloud as your all-in-one agile ALM solution.
You want a modern solution, but you DON’T want:
The frustration of creating complex configurations and integrations.
The workload of writing system documentation.
The uncertainty of whether your system complies with industry regulations.
You need the Agile Compliance System for Jira.
An all-in-one application lifecycle management (ALM) solution specifically designed for life science companies
using Atlassian Jira Cloud.
The Ultimate Toolbox
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.
Specialized Support
Keep your team unstuck with one-on-one support from an expert who understands your industry. Get help with all your questions and challenges, including technical questions about Jira and best practices for using Jira in a highly regulated environment.
Affordable
Use best-in-class software while saving up to 90% of the cost of competing solutions.
I understand the challenges of working in an FDA-regulated environment
Hi! I’m Aaron.
With over 15 years of experience in the life sciences industry, I’ve helped dozens of companies– including Pfizer, Merck, Bayer, and Biogen–to modernize their ALM processes while maintaining regulatory compliance.
I know firsthand the complexities of configuring and validating Jira Cloud for regulatory compliance. It can feel overwhelming, especially when concerned about potential blind spots that could cause problems during audits.
That’s why I’ve created the Agile Compliance System for Jira. It’s designed to transform your uncertainty into confidence, providing pre-built configurations, best-practice agile workflows, ISPE GAMP 5 validation deliverables, and expert support to ensure your Jira Cloud deployment is both compliant and efficient.
Schedule a call today to find out if the Agile Compliance System for Jira is right for you.
Your path to a compliant ALM solution:
1. Schedule a call
Schedule a free consultation. We’ll discuss your needs and determine whether the Agile Compliance System forJira is right for you.
2. Try it risk-free.
I’ll give your team a dedicated trial environment to test Jira as an all-in-one solution. If you don’t like it, you can walk away without paying anything.
3. Launch with confidence.
We’ll work together to quickly configure, validate, and launch Jira Cloud in your company.
What’s included in the Agile Compliance System?
The Agile Compliance System for Jira has two pieces: Agile-ready Jira Workflows and Audit-ready Documentation.
Agile-ready Jira Workflows
The Agile-ready Jira Workflows are prebuilt Jira configurations designed specifically for teams in life science industries such as medical devices and pharmaceuticals. They provide the flexibility and speed of agile practices while enforcing the strict controls and traceability needed for regulatory compliance.
These configurations include best-practice agile workflows for requirements, risks, test cases, test plans, test executions, user stories, defects, and more. And they’re all designed to be compliant with 21 CFR Part 11 and IEC 62304.
Better yet, keeping everything inside Jira makes it easy to maintain complete end-to-end traceability across your entire ALM solution: requirements, risks, tests, test evidence, and defects can all be linked, traced, and reported for easy auditing and compliance.
Audit-ready Documentation
The Audit-ready Documentation package eliminates the guesswork and heavy lifting of creating an ISPE GAMP 5-compliant validation package for your Jira Cloud site. These documents are pre-written to align with your new Agile-ready Jira Workflows, saving your team weeks of effort and ensuring everything is consistent, accurate, and audit-ready.
This package includes everything you need to get started validating your system: a validation plan, risk assessments, supplier assessments, user requirements, configuration specifications, user acceptance tests, Part 11 trace matrix, and more.
Plus: 90 days of one-on-one support
I want you to be successful. The Agile Compliance System for Jira comes with 90 days of personalized support to keep your team unstuck and your deployment on track. This includes weekly coaching sessions, flexible-use consulting hours, and unlimited email-based support.
I will help you tailor the system to your needs, monitor your validation progress, address challenges, and provide enablement training to your team.
A risk-free commitment to your success.
No up-front payments
When you purchase the Agile Compliance System for Jira, you pay nothing until after I deliver.
Validation guaranteed
If your system is not validated and approved for use within 90 days, I’ll continue working with you for free until it is.
Compliance guaranteed
If my system is ever found to be out of compliance, I’ll refund double your money…contractually guaranteed.
What will you learn when you schedule a call?
1. Is this the right solution for you?
I only want happy customers. We’ll start with a brief discussion about your current situation and needs to ensure the Agile Compliance System is right for you.
2. How much does it cost?
Next, we’ll discuss how much the Agile Compliance System for Jira costs. (Less than you expect!) And I’ll show how the cost is almost insignificant compared to the amount of money it will save you.
3. How to get started?
Finally, we’ll discuss the steps to get you set up with your own trial environment so that you can evaluate the Agile Compliance System for yourself.
Is YOUR Jira site truly Part 11 compliant?
Download this FREE traceability matrix to find your compliance gaps.