Welcome to QMS University
No matter if you’re a seasoned pro or new to the industry, quality management can get complicated. That’s why we created QMS University, your go-to resource hub for practical tips and tools to help you build, manage, and improve your quality management system.
From the foundations of quality to the inner workings of quality management data, dive into each course to find the blogs, webinars, and tools you need to make quality both more impactful and less stressful.
- 101: Setting Up Your Quality Management System
- 201: GxP Management in Motion
- 301: Driving Continuous Improvement
QMS 101: Setting up Your Quality Management System
Whether you’re launching your first QMS or refreshing your existing system, these QMS 101 content packages help set the foundation for effective, efficient, and compliant quality management.
Get familiar with key terms, the core components of a quality management system, and what makes a QMS successful.
- Blog | Quality Definitions to Know
- Blog | Creating a Quality Management System Foundation
- Blog | RIMS vs LIMS vs TMF vs eQMS
Brush up on writing SOPs, building a training matrix, and organizing your GxP materials to keep quality expectations clear, controlled and easy to manage.
- Blog | How to write an SOP
- Blog | How to create a training matrix
- Blog | 4 steps to improve document management + document control goals for quality teams
- Webinar | How to structure your quality materials in an eQMS
Understand which quality management tools make compliance possible with less complexity. Get tips on how to compare QMS software platforms, what questions to ask vendors, and how to estimate total cost of ownership.
- Blog | Building vs Buying Your eQMS: Which is right for you?
- Blog | How to Vet an eQMS
- Blog | 6 eQMS features that simplify your QMS
- Blog | How much does an eQMS cost?
- Tool | eQMS Cost Calculator
- Webinar | How to choose the right eQMS
QMS 201: GxP Management in Motion
Time to go from planning to execution. Set your GxP quality management in motion with content packages that focus on QMS implementation, quality software validation, quality audits, change controls, and more.
From migrating data to configuring the system to meet your organization’s unique quality needs, get practical steps for rolling out your QMS.
- Blog | How to migrate your data from an old eQMS to a new one
- Blog | How to set up your eQMS implementation for success
- Blog | Configurability vs Customization: How much flexibility do you need?
- Blog | Why does configurability matter to life sciences organizations?
- Webinar | How to successfully implement an eQMS
Learn how to conduct effective Root Cause Analyses, design an efficient change control workflow, and prepare for audits with confidence.
- Blog | How to conduct a Root Cause Analysis
- Blog | How to create a change control workflow
- Blog | Quality Audit Best Practices: How to Simplify Inspections with Your eQMS
QMS software validation is required – validation stress is not. Get a breakdown of CSV vs CSA validation requirements, tips on navigating the process, plus a useful validation checklist.
- Blog | All about eQMS validation: CSV to CSA
- Blog | When (and why) does your eQMS need revalidation?
- Webinar | How to navigate eQMS validation and audits
- Tool | Validation Checklist
AI is transforming quality management, but in regulated industries, innovation must go hand-in-hand with compliance. Learn how to evaluate AI tools, validate them for use in your QMS, and apply AI in ways that align with regulatory expectations.
- Questions to Ask Before You Adopt an AI Quality Management Tool
- How to Validate AI Tools: A Guide for Quality Management Teams
- How QA Leaders Can Use AI Compliantly in Life Sciences Quality Management
- Quality Management Industry Report: How Life Sciences Teams Feel About AI’s Role in Compliance
QMS 301: Driving Continuous Improvement
Learn the quality metrics that matter, get tips on building quality management reports, and understand the signs it’s time to take action and evolve your QMS.
- Blog | Data is Power: Metrics that Quality teams can track to drive continuous improvement
- Blog | How to build a quality management report
- Blog | How your eQMS should evolve as your quality needs grow
- Webinar | Quality data reporting
You know the impact of strong quality management – but does the rest of your leadership team? Learn how to talk about the ROI of quality management in a way that resonates with key budget stakeholders.
- Blog | Quality Q&A: What's the real ROI of an eQMS?
- Case Study | Vanguard
- Webinar | How to prove the ROI of an eQMS
- Tool | ROI Calculator
As your organization grows, so do your responsibilities around compliance and data security. Get a refresher on protecting sensitive data in your eQMS and keeping electronic signature integrity.
- Blog | Best practices for eQMS security and data privacy
- Blog | How to keep electronic signatures GxP compliant