In eQMS 101, we covered the basics for choosing and getting buy-in for the quality management tool you need. In our eQMS 201 ebook, we shared tips on how to implement and configure your electronic quality management system so you hit the ground running.

And now, we’re going in-depth on keeping your eQMS efficient and impactful for years to come in eQMS 301: Best practices for eQMS revalidation, data security, and quality ROI. With insights sourced from Quality leaders who have been – and still are – in your shoes, we hope this eBook is a helpful resource on your Quality journey.

Quality metrics, quality KPIs, and quality data reporting best practices

From trend data on deviations to CAPA effectiveness, Quality teams can provide leadership with actionable insights on what’s working, where problems are hiding, and where to invest more resources. We cover why quality metrics matter, which quality metrics and KPIs to track, and how to build better quality data reports so leadership pays attention. 

eQMS data security and privacy standards

Data security and confidentiality is a major priority for Quality teams, and protecting your data means staying alert and being proactive with data management. Take eQMS data privacy a step further with these data security best practices and eQMS security certifications. 

When – and how – to revalidate your quality management software

Did you know you may have to periodically revalidate your software? Software systems – such as eQMS platforms – make updates often, and depending on the size and impact of those updates, you may need to revalidate the system. The tricky part is determining when revalidation is necessary and when you can requalify your eQMS without it.

Find out when (and why) your eQMS needs revalidation, plus get best practices that make the process as easy as possible.

Signs it’s time to update your QMS processes and quality management workflows

As your GxP organization grows, global regulations change, and your quality processes mature, your quality management tool has to keep pace. Learn to spot the signs it’s time to update your eQMS workflows and configurations and get step-by-step guidance on how to update your quality management processes.

Want to test your quality knowledge before diving into the 301 content? See if you know the answers to these questions:

Question 1: True or False: eQMS revalidation and eQMS requalification are the same thing.

Question 2: True or False: It’s critical to test any eQMS configuration updates in a sandbox environment before going live with changes. 

Question 3: This is a report that audits how a company – specifically one which uses cloud-based storage – handles sensitive data: 

• A. ISO 9001:2015
• B. GAMP5
• C. SOC 2 Type II
• D. 21 CFR Part 11

Find the answers on pages 9, 15, and 19 in the eBook!