June 2015 Posts

EQMS Implementations: A Matter of Need and Speed

EQMS Implementations: A Matter of Need and Speed

Rob Harrison, Research Analyst, LNS Research

It’s fairly obvious to anyone with their eye on industrial operations that manufacturing has increased in speed tremendously over the past few decades due to several factors like automation, increased collaboration across departments, analytics that allow greater agility and responsiveness, and others. This is true in virtually all industry verticals.

What may be less obvious to the onlooker but is no less true, is the parallel pressure that’s been placed on quality organizations to elevate their systems and processes to deliver ever-higher quality and consistency in products. Spurred on by factors like increasingly global and disparate suppliers, tightening regulations and compliance initiatives, and immediate potential for brand and reputation damage via social media, the writing is on the wall that the processes and systems of yesteryear are no longer cutting it. Today, with increasing frequency, these issues are shaping Enterprise Quality Management Software (EQMS) implementations. But aren’t these a major undertaking? Yes, mostly—but not out of pure necessity. (more…)

The Anatomy of Great Risk-Based GMP Audits

The Anatomy of Great Risk-Based GMP Audits

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

If you’re responsible for planning and carrying out your company’s internal audits, you know how much planning and effort it takes to monitor your quality system for GMP and ISO compliance. As your quality system has matured, you’ve probably noticed that certain sites, departments, or processes require more of your attention, while others are consistently in compliance and don’t need as much assistance. If this is the case in your organization, it’s time for you to consider a risk-based approach to your internal quality system audits. (more…)