July 2019 Posts

The Future of QMS

The Future of QMS

Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions, an IQVIA company

Quality Management has traditionally been an area of manufacturing that was slow to adapt and change to technology shifts in the market. Over the past few years, enterprise Quality Management Software (QMS) systems have stepped up their game and caught up to the market by bringing functionality such as 3rd-party secure access, advanced analytics, and proactive monitoring to their portfolio stacks. (more…)

Auditing and Testing in the Global Pharmaceutical Supply Chain

Auditing and Testing in the Global Pharmaceutical Supply Chain

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Auditing your suppliers is a key part of your quality and compliance improvement. A pharmaceutical company needs to insist on a confidential, in-depth audit of every part of the facility, operations, and quality systems relating to the materials it wants to purchase, including manufacturing and testing details.

In addition to regular, thorough manufacturing facility audits, the company should actively ensure that it or its brokers have reliable, up-to-date knowledge and verification of the drug substance upstream to ensure that materials really do come from approved sources. (more…)

8 Internal Drivers for Multi-site Asset Management Software

8 Internal Drivers for Multi-site Asset Management Software

Jim Erickson, President, Blue Mountain Quality Resources

Life Sciences enterprises are increasingly looking to establish a foundation for improving processes and procedures that will drive down their overall cost of production, labor, and compliance. As a result, demand is growing to adopt multi-site, GMP-compliant Asset Management software as a pillar of that foundation.

A multi-site regulatory asset management solution enables companies to standardize maintenance and calibration procedures across all of the facilities, driving corporate efficiencies and supporting global compliance standards. (more…)