White Papers

FDA Fronts Pivotal Life Sciences Trend in 2020

This publication provides an in-depth look at the FDA’s transformation and addresses how the agency’s initiative will impact manufacturers of regulated products.

Metrics That Matter for Contract Manufacturing

Quality System Metrics That Matter

Business Case for Cloud Migration

Metrics That Matter for Quality Manufacturing

Your organization can improve the metrics that matter most to your manufacturing operations by using digital production records found in Manufacturing Excellence. Learn more...

Supply Chain Benchmarking Data Reveals Differences Between Pharmaceutical and Medical Device Manufacturers

Quality 4.0 for Quality Leaders: LNS Research

Extend Your Digital Edge: Bringing Production Record Data Online to Drive Intelligent Manufacturing

Bridging the Gap: Manufacturing Software and the New Digital Edge

Being successful in manufacturing today requires more than selecting the right manufacturing software. It entails digitization all the way to the shop floor. Read more...

The Smart Way to Do Smarter Food Safety

U.S. FDA now puts an emphasis on adapting new technologies to make the food supply chain safer. Fortunately, preparing for new regulations and complying with the FSMA can both be done by digitizing.

9 Pitfalls to Avoid During the Document Control Process

In a regulated environment, the document control process can either be an obstacle course replete with pitfalls, or it can be a smooth ride to a successful product launch.

Top Device History Record Pain Points

Device history records (DHRs) are the most important artifacts generated in the course of medical device manufacturing, yet many manufacturers still rely on manual, paper-based DHR systems.

The Business Case for Moving to the Cloud

According to Garner Research, by 2019, over 75% of Life Science R&D IT organizations will adopt cloud-first application deployment strategies.

China’s Changing Pharmaceutical Landscape

While already overseeing the world’s second-largest pharmaceutical market, China’s State Administration for Market Supervision is working to bring international drugs into the Chinese market faster.

21st-Century Manufacturing: An Investment in Digital Data and Operational Efficiency

The manufacturing sector is firing on all cylinders, but that doesn’t mean executives aren’t still seeking ways to reduce costs and achieve greater ROI.

GAMP 5 Category 4: MasterControl Product Positioning

Ever since 1991, GAMP has worked to help the life sciences validate their computerized systems as fit for intended use and compliant with regulatory requirements. Learn more, read the white paper.

6 Big Data Concepts Every Life Sciences Executive Needs to Understand

Industry 4.0 involves the digitization and interconnectivity of all functional entities. Key players in this trend include big data, advanced analytics, automation and cloud computing.

Upgrade to Cloud - Life Science Software Vendors

Forward-thinking software vendors are making it easier than ever for companies to take their processes to the cloud. Learn about the benefits of this move in this new white paper.

Do I Need to Validate? How to Make an Informed Decision in 4 Steps