05.02.22 -- A Data-Driven And Technology-Supported Approach For Quality Excellence

This guide will help you understand the fundamental components of a quality management system (QMS) software and how QMS solutions are evolving to keep pace with business dynamics. Learn how advanced digital tools can help you achieve quality excellence now while paving the way for even greater successes in the future.

Most executives cite the high cost of adopting technology as the main reason they reject plans to invest in digital systems. This article offers guidance that will help you quantify and communicate the importance of quality, and how a digital QMS delivers considerable savings.

In this article, we will discuss implementation of a phase-appropriate QMS and the importance of starting early in the product development life cycle, the disadvantages of using a manual paper-based QMS in the early phases, and advantages to your company by using a digital QMS.

21 CFR Part 11 is meant to allow the use of electronic records as much as possible, while safeguarding the integrity of data and systems and the validity of electronic signatures. With the evolution of technology, 21 CFR Part 11 is more applicable than ever, due to the increased use of digital technology for these quality management tasks.

Employing advanced digital tools designed to connect data allows pharma and biotech companies to proactively drive efficiency, accelerate time-to-market, improve product quality, and, ultimately, achieve better patient outcomes. Adopting a data-driven and technology-supported approach to quality and product life cycle management can enable pharma and biotech organizations to not just survive but thrive.