Friday, 16 February 2018Justin L. Smith, Director of Product Management, Pilgrim Quality Solutions
Within regulated environments, such as the Life Sciences community, there are a number of top-of-mind business challenges. Key among them is to increase operational efficiencies while keeping pace with an ever-evolving regulatory landscape. A daunting challenge to say the least, mainly due to the “ever-evolving” factor.
To address the challenge, companies invest in fantastic new systems and software that provide the foundation for compliance while also affording significant efficiencies over their paper or manual processes. However, too often, companies get stuck on their initial version of software due to the cumbersome impact that computer system validation has on the upgrade process.
Friday, 02 February 2018Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions
As product recalls, product bans, drug shortages, plant shutdowns, and enforcement actions continue to rise, industry and regulators alike are looking for answers on how to change the perspective of the Life Sciences industry from one of Compliance
to one of Quality
Is the solution to increase the amount of data we capture and report within our documents? After all, we so carefully record a great deal of data in a Quality Management System
(QMS). No, data in and of itself, is not the answer. While data/metrics go a long way toward accomplishing the shift from compliance to quality, that data needs to be transformed into intelligence that is informed, actionable, proactive, and predictive.
Tuesday, 30 January 2018Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions
In my role as an industry solutions consultant for an enterprise Quality Management Solutions (QMS)
provider, I get a lot of insight into the quality challenges facing manufacturing and service organizations. I’ve concluded that a lot of those challenges are internally generated.
The source, more often than not, is a communication issue, or a lack of communication between internal parties that are not on the same page regarding goals, objectives, strategies, or priorities. The result, far too often, is what some would call organizational paralysis. It’s what happens when multiple parties can’t agree to agree. No one wins, but everyone loses.
Friday, 26 January 2018Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions
Selecting an enterprise-wide Quality Management System (QMS)
provider that will allow you to meet all of your quality management goals might seem overwhelming. To help allay the intimidation factor, last week, I wrote a piece titled Don’t Be Shortsighted When Evaluating eQMS Solutions
that examined what constitutes a successful QMS vendor evaluation process, one that establishes a lasting partnership between a client and a vendor. The discussion asserted that the determining factor is whether a company enters into the evaluation process with a long-term vision for organizational quality, versus simply conducting a point solution selection.
Tuesday, 23 January 2018Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions
Suppose you have just delivered a Quality Management Solution (QMS)
to your customers, and immediately afterward, you receive an invitation to a webinar titled “Why Quality Doesn’t Matter.” What do you do? You sign up!
The anticipation of what Dr. Marla Phillips, Ph.D., Director of Xavier Health, Xavier University, might impart based on this webinar title, was exciting, maybe even a little bit anxiety- inducing. After all, quality is what we strive for, and it’s been the focus of industry for decades. In Life Sciences, not only are we striving to improve quality, we are equally focused on ensuring our global regulatory compliance