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The Latest from Our Expert Consultants

What 2018 and the FDA Have in Store for Electronic Medical Device Reporting (eMDR) Submissions
Life Science companies that manufacture medical devices need to stay on the forefront of compliance with the latest regulatory requirements. Recently, the FDA laid out updated requirements for..
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4 Signs it's Time to Standardize Your Quality Management System
Global organizations are increasingly grasping the power behind data and process streamlining; the benefits will pave the way for growing a culture of quality and compliance. Becoming a mature,..
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Making the Move: How to Transfer Your QMS to a Cloud Solution
For years we’ve heard about the benefits of moving to the cloud. Lower costs, staying current with the latest technology, and scalability as your company grows certainly give you a competitive..
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3 Tips for an Effective Quality Management System (QMS) Training Program
Many Life Science and Medical Device organizations struggle with how to align training compliance with business strategy, resulting in reactive and often overwhelming training without any real value,..
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Change Management: How Project Managers Can Effectively Manage Change
Project managers play such an important role in an organization’s ongoing projects and implementations, and especially now more than ever before. Senior execs typically rely on their PM’s to be the..
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How to Optimize Your Investment in EQMS: Facilitate Clear Communication Between Systems and People
Industry information from service providers dictates that an EQMS is so vital to an organization’s optimal performance, that increased attention to fine-tuning quality ecosystems is directly related..
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Automation of Audit Report Writing & Distribution via Your Audit Management System
Managing your audit program is a challenge faced by many Life Sciences companies and those professionals directly responsible for maintaining an organization’s auditing processes. Regardless of..
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The 4 Elements for Effective Project Management
Here’s a scenario that happens far too often. A company needs their IT and business processes to be more streamlined, efficient, and cost-effective. They come up with a plan, but lacking the time or..
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How to Best Manage your Annual Audit Plan
An organization’s firm understanding of their annual audit scope is fundamental to successful audit planning and the effectiveness of their overall Audit Management System. It’s essential for..
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How to Streamline QMS Administration for a More Efficient Operation
As a Stream Support Manager, there are some common situations that I come across when taking on new clients. There are so many organizations out there that suffer from either a lack of in-house..
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Mergers, acquisitions and divestitures have become much more prevalent in the pharmaceutical industry over the last few years. It seems that recently almost every day we hear news about a mega..
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Is Your Audit Management System Running on all Cylinders?
In a growing global economy, companies need to track and manage the quality of their corporate functions, business units, and suppliers NOW more than ever.
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