GAMP® 5 Guide, 2nd Edition Template for Confluence Cloud

This GAMP5 Compliance Toolkit is specifically designed for software suppliers who develop and deliver software solutions for clients in regulated industries such as pharmaceuticals, biotechnology, and life sciences. If you’re a supplier—not the regulated company—this package provides everything you need to align your processes with GAMP5 guidelines and meet the stringent expectations of your clients.

Check out the Preview File here!

Who Is This Toolkit For?

This package is specifically designed for software suppliers - NOT for the regulated companies themselves (e.g., pharmaceutical manufacturers). It empowers you to:

• Streamline compliance processes.

• Deliver compliant software solutions without unnecessary complexity.

• Build trust with your regulated industry clients by demonstrating adherence to best practices.

If you’re a supplier building software for use in GxP-regulated environments, this toolkit equips you with all the essential tools and documentation to ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and other critical standards.

What You Get in This Package:

• Standard Operating Procedures (SOPs): 21 comprehensive SOPs tailored for software suppliers. The below SOP categories are provided with the Toolkit:

  • Quality Control

  • Information Security

  • Operations

  • HR

• Technical File Documents: Essential documents for compiling and maintaining your Technical File, ensuring your software solutions are fully documented and compliant with regulatory expectations.

• Forms: 17 including pre-validated formats to save time and ensure consistency.

• Job Descriptions: 8 clearly defined roles with responsibilities for your compliance-focused team.

• FDA 21 CFR Part 11 Checklist: A detailed guide to help ensure your software solutions meet electronic records and electronic signatures requirements.

• EU Annex 11 Checklist: A comprehensive checklist to align your processes with EU regulations for computerized systems.

Why Choose This Toolkit?

With this package, you don’t have to reinvent the wheel. It simplifies the path to compliance, saving you time and resources while reducing risks. Whether you’re developing software for pharmaceutical production, clinical trials, or quality management systems, this toolkit is a critical asset for meeting regulatory demands and client expectations.

Ready to Simplify Compliance?

Purchase the GAMP5 Compliance Toolkit today and equip your team with the resources to deliver compliant, high-quality software to regulated industries.

How does it work:

Easy setup with our step-by-step guide:

1. Purchase the GAMP5 Template pack from our store and receive a license key.

2. Install the QC Template Launcher app from the Atlassian Marketplace.

3. Open the QC Template Launcher app from the Apps menu (Apps → QC Template Launcher).

4. Enter the provided license key for validation.

5. Configure your GAMP5 space by giving it a unique name and space key.d a unique space key.

6. Import the GAMP® 5 Guide, 2nd Edition template by clicking the “Import” button.

7. Start Building Your GAMP5-Compliant Processes!