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QUALITY TALK – May 2021

eQMS Software Budget Exercise

#buyersguide Are you planning to submit new eQMS software for budget approval in the coming fiscal year? Now is the ideal time to start building your business case for finance and other key stakeholders. Learn how to quantify the expected benefits of the new platform, write a solid justification statement, calculate ROI, and more in our software buyer’s guide.

Build Your Case

Developing a PQ Protocol

#webinar #softwarevalidation #compliance Performance Qualification (PQ) is an integral part of the software validation requirements set forth by the FDA and ISO. Hear our panel of experts discuss the process of developing a PQ protocol and supporting documentation for your medical device software validation.

PQ Confidence

5 Signs It’s Time to Go Digital

#blog Are you burdened by administrative activities, missing time-to-market targets, or overlooking regulatory compliance updates? These may be indicators that it’s time for your medical device regulatory team to go digital. Explore these key indicators in more detail and learn how you can make the transition to a more unified, collaborative digital system.

Go Digital

3 Steps to Training Automation

#bestpractices Have you considered ditching your spreadsheets and shared drives for a more automated training management system? In today’s fast-paced and highly regulated market, having a robust system in place that utilizes the latest technology is a smart investment. By implementing these three steps, you’ll be in a better position to simplify audits, improve product quality, and reduce compliance risks.

Take Steps