Life Science Regulations, Compliance, and the Move Toward QMS Software

A timeline of FDA and Sparta System activities

Quality Digest

February 19, 2019

Within the life science industry, federal and industry regulations have prompted the need for compliance, and that trend has only increased in magnitude and complexity. Along with that has come technological solutions to enable both compliance and efficiency, without which life science organizations can’t thrive.

The following short timeline offers a broad summary of how these elements have interacted during the last several decades. The industry has come a long way.


Thou shalt obey the FDA

The U.S. Food and Drug Administration (FDA) first prescribes current good manufacturing practices (cGMP) requirements for medical devices, including quality management system (QMS) requirements.


Regulators! Mount up!

With the passing of the Fines Enhancement Law, the FDA fines increase, as does approval for drug development. Industry focuses perhaps too much on regulatory compliance.


The mouse is mightier than the pen

Early quality management software systems come into use.

Sparta Systems is founded out of the need for a fully compliant quality management system (QMS). Working alongside life science companies and FDA insiders, TrackWise software is born and deployed by five of the largest pharmaceutical companies in the world.


Life beyond compliance

Companies and regulatory bodies begin to understand that a good compliance record doesn't always translate into good quality products or processes.

Sparta adds hundreds of new clients and becomes the industry-standard QMS platform. TrackWise helps companies go beyond compliance by allowing them to automate quality processes on a centralized platform.


Mergers, divestitures, acquisitions... oh my

The industry sees a lot of consolidations, as well as acquisitions and divestitures as life science companies realign their corporate strategies. A new set of companies moves into the life sciences market, along with new commercial models.

Sparta begins introducing solutions that streamline and improve supplier quality management, create actionable business insights, and provide users on-demand remote access from any device and from anywhere in the world.


Clearly complex

The level of life science complexity grows exponentially, and so does the need to improve visibility and collaboration both within the enterprise and across the value chain.


The consumer is becoming the center of the universe

With the advent of personalized medicines and consumer products, expectations change, and so do demands on quality systems. Complaints are just a tweet away.

Sparta launches TrackWise Digital, a next-generation cloud QMS platform that allows life science companies to address key operational and regulatory challenges in their supply chain as well as quality across the enterprise. It also enables companies to more quickly adopt Industry 4.0 technologies.


Sailing on a sea of data

Contemporary quality teams begin to leverage data to create actionable insights and optimize performance and efficiency. Total cost of quality and risk assessments become critical.


The bridge to the future: digital transformation

To deliver personalized experience to customers and remain profitable, companies must embrace digital. Quality plays an unprecedented role in all of it.


About The Author

Quality Digest’s picture

Quality Digest

For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.