Additional Content
QuVa Case Study
QuVa Pharma, a leading national 503B outsourced sterile compounding company, has a broad portfolio of ready-to-administer products that hospitals and health systems rely on to ensure high quality...
2020 Ultimate Guide to Connected Quality Data
Visualizing a new data-centered quality paradigm. When the first Nokia and Motorola cell phones that were affordable and small enough to fit in your pocket hit the market...
Supply Chain Benchmarking Data Reveals Differences Between Pharmaceutical and Medical Device Manufacturers
WD-40 Company Case Study
WD-40 Company needed a way to ensure that every drop of product produced by globally diverse contract manufacturing organizations (CMOs) measured up to the company’s unwavering standard of quality.
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.
Top 8 Obstacles in Pharma & Biologics Product Registration & Submission Management
Automation can help pharmaceutical and biologics companies along the path to a global product launch. This white paper identifies common problems with submissions and how best to address them.
eTMF Management Essentials
Every organization engaged in a clinical trial must manage and maintain all trial-related content, documents, and data in a manner that supports the claims to the safety and efficacy of a product.
Ten Most Common Reasons for FDA 483 Inspectional Observations in Pharmaceutical Environments
The U.S. Food and Drug Administration has released data on the most common observations it makes during inspections of pharmaceutical facilities. This white paper explores the top 10 deficiences.
ICH Q10 - Pharmaceutical Quality Systems - 'An Opportunity for Us All'
The ICH Q10 Guideline 'pharmaceutical quality systems' was signed off as a Step 4 document at the ICH meeting in Portland, Oregon, in June 2008.
Six Corporate Oversights of Quality and Compliance Issues in Pharmaceutical Environments
This white paper discusses six areas senior management tend to overlook, from proper investment in CROs to personnel training, and what the implications are in terms of compliance.
How Software Helps Pharma/Biotech Maximize Value of External Resources
Identify strategic ways that software solutions and automation can support overall efforts to secure external resources, from funding of research studies to establishing licensing deals.
The Pharmaceutical Industry's Transition to Electronic Processes
Pharmaceutical companies stand to experience significant operational advantages by transitioning to automated, electronic processes instead of continuing to use manual paper-based or hybrid systems.
MasterControl EBR™ Toolkit for Pharmaceutical Companies
MasterControl offers this collection of resources to help pharma manufacturers on their path to paperless.
MasterControl Registrations™ Toolkit for Pharma & Biologics Companies
MasterControl Registrations for eCTD is a cloud-based solution designed to streamline content generation and the collection and management of artifacts required for regulatory submission.
12 Free Resources to Boost Your Pharmaceutical FDA Readiness
This FDA Readiness Toolkit is designed to help pharmaceutical companies simplify compliance with FDA standards and streamline quality processes.