The Challenges of Building an Effective Structure for Sponsor-CRO Partnership
Managing quality in a clinical trial must begin long before the first patient is enrolled and continue thro...
Most Recent Flipbooks
Top 5 Trends in the Pharmaceutical Industry in 2019
This white paper thoroughly examines five trends that are increasingly influencing the way companies are positioning themselves in a competitive and lucrative pharmaceutical industry.
Top 5 Medical Device Industry Trends in 2019
In this white paper, MasterControl asked four medical device experts to share their insights on trends and developments that are likely to affect the industry in 2019.
Top Nutraceutical Trends of 2019
From supplements for pets to the expanding use of cannabis, nutraceuticals are set to transform in 2019 into an even more promising industry.
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.
Top Manufacturing Device History Record Trends in 2019
Examine technology-heavy manufacturing trends that the medical device industry can expect in 2019 and beyond, particularly as they relate to device history records (DHRs).
Top Manufacturing Batch Record Trends in 2019
Metrics That Matter For Quality Manufacturing
The fully connected Manufacturing Excellence solution reduces production errors, improves cycle times, enhances line performance, accelerates product release, and integrates manufacturing and quality.
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
Stop Managing Paper In A Data-Driven World
Axendia shows how companies that shift from paper to data-driven intelligence are able to better leverage manufacturing data to improve quality, compliance, and business improvement efforts.
Compliance and Technology: How to meet changing FDA expectations
The book explores how the use of technology in the past decade has helped both regulated companies and regulatory agencies in easing the pains and costs of compliance.
Top Batch Record Pain Points
Despite a multitude of manufacturing software solutions on the market, most pharmaceutical companies still rely on manual, paper-based systems to compile and maintain their batch records.
Get Ready: Why Designing Quality Into Your Product is Key to 510(k) Success