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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.

A modern technology foundation creates an agile ecosystem that lets you flex and adapt your business as needed. Embracing digital is now so instinctive, you would digitize and automate everything.

Learn how automated document control solutions help organizations better manage corrective and preventive actions (CAPA), change control, training, and many more quality processes.

Whether expected or unexpected, minor or complex, change is a constant in any manufacturing environment.

This white paper shows how an optimized QMS can help a company avoid quality roadblocks and form the foundation for long-term regulatory compliance and, ultimately, for ensuring market success.

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.

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

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.

The Food Safety and Modernization Act (FSMA) put stricter regulations in place that increased demands on your company’s quality management system (QMS).

Management of a clinical study must incorporate not only all the activities and records that comprise a study, but the capacity to efficiently assess status and development shifts at any given time.