You Need On-time and On‑Budget Drug Development

Because the costs of drug development continue to climb, you have to work fast. The pressure is on to develop safe, effective drugs quickly. Mistakes cause delays. With each delay, you’re less likely to recover costs and make a profit.

The solution is a digital quality management system (QMS) that helps accelerate the drug development cycle.

You Can’t Afford Data Integrity Issues

Data issues risk your reputation. Just ask one of the many pharma companies that recently made headlines because their data was inaccurate. You don’t want that kind of publicity. Negative press coverage almost guarantees you’ll lose the trust of your customers.

Regulators are focused on quality data, and you should be, too. If you aren’t prioritizing data, you not only risk your reputation, but you jeopardize compliance as well. The U.S. Food and Drug Administration (FDA) has stressed time and again that accurate data is critical to the development and approval of drugs. And yet, one of the top reasons for warning letters in the pharma industry continues to be incomplete/inaccurate data.

A digital QMS isn’t optional. With a digital QMS, meet the FDA’s expectations that your pharma company will focus on quality data throughout the product life cycle – from new drug research through post-market safety monitoring.


MasterControl’s eCTD submission and product registration management software automates, simplifies and accelerates submissions and product registrations.

Ensure compliance and improve efficiency by automating your paper-based systems.

The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.

Managing an electronic trial master file (eTMF) is a complex and labor-intensive effort. Centralize and streamline your clinical activities with MasterControl eTMF software systems.

MasterControl's supplier management solution automates supplier management processes and ensures supplier quality and compliance.

A clear path to global regulatory submissions.

Simplify clinical management with a single platform. MasterControl allows you to connect all clinical data, documents, tasks and processes.

Automate batch processes. Improve efficiency. Ease growing pains. A proven recipe management software system can help you do it all.

MasterControl software automates equipment calibration processes. It helps manufacturers improve their performance and ensure audit-readiness.

MasterControl’s audit management software system automates tasks so that companies can successfully pass audits.

Unify all risk-related activities and documents for efficient and consistent risk management.

Streamlined investigation and resolution of product deviations. Improved quality. Simplified compliance. MasterControl deviation management software can help you make it happen.

Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.

Make sure gaps in employee training don’t derail your regulatory compliance.

Quality can never be a differentiator if it's an afterthought or a box to be checked. A complete, end-to-end digital quality management system makes quality at the source possible – and compliance issues a thing of the past.

Digital document control systems introduce automation into your processes. A digital solution is not only more efficient, it also makes it easier to keep up on regulatory changes and maintain compliance.


MasterControl, Inc.

6350 South 3000 East

Salt Lake City, UT 84121


Phone: Sales 1.888.873.5164


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