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The Latest from Our Expert Consultants

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The Move to Quality 4.0: Analytics & 'Big Data'
/ Process Stream
Continuing on our journey into 'Quality 4.0', this week, we take closer look at Analytics & 'Big Data'. These industry buzzwords have been widely-used as of late, but they do warrant a deeper..
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The Move to Quality 4.0: Understanding Emerging Technology Use-Cases
/ Process Stream
Continuing on our journey into 'Quality 4.0', this week we take a closer look at emerging technologies and a few of their current and projected applications. 
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The Move to Quality 4.0: Technology-Enabled Solutions
/ Process Stream
Last week, we mentioned some strategy and implementation methods for moving to Quality 4.0. This week, we take a closer look at technology-enabled solutions.
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The Move to Quality 4.0: digital Transformation
/ Process Stream
Last week, we mentioned some strategy and implementation methods for moving to Quality 4.0. This week, we take a closer look at Digital Transformation.
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THE MOVE TO QUALITY 4.0: THE PROCESS STREAM PERSPECTIVE
/ Process Stream
We’re back in our Princeton, NJ Headquarters after an informative and enlightening week down in Orlando for Sparta Systems’ annual Sparta Connection TrckWise User Conference.
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What to Expect at Sparta Connection 2018
/ Process Stream
That time of the year has come again! We are in full prep-mode for the annual Sparta Connection Conference. Process Stream will have an expanded presence this year, and we are excited to reconnect..
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How the Right Business Tools Let You Focus on Data Analytics
/ Mickey Shah
Traditional data storage, organization, and retrieval models render analytics far more time-consuming than they need to be, severely diminishing their value in the process. Meaningful analytics are..
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The Publisher/Consumer Bottleneck: How Data Warehouse Models Limit Your Organization
/ Mickey Shah
Your organization’s approach to data access and analytics may be resulting in massive inefficiencies and delays that can impact your operation at every level. And worse – you may not even realize it.
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PMO Methodologies: An Exploratory on Project Planning and 'Getting Across the Finish Line'
/ Shameica Woollery
With the growth of computer system and application development and its use, Project Management, as a discipline, has grown leaps and bounds over the past decade or so, particularly in the area of..
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Management Strategies Series - Volume 1: Dealing with Unplanned Demand in Your Quality Ecosystem
/ Rahul Bhatia
Demand related to resource management is a perpetually evolving piece of our profession. There is a constant re-prioritization of efforts that can have profound impact on our business and bottom..
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LOOK ABOVE AND BEYOND THE IMPLEMENTATION: THE IMPORTANCE OF HYPERCARE AND ONGOING SUPPORT
/ Rahul Bhatia
IT professionals within the Life Sciences industry traditionally characterize successful engagements as relying on solid planning and a strong implementation.  The completion of the development and..
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QUALITY SYSTEM VALIDATION AS A JOINT VENTURE BETWEEN INTERNAL RESOURCES AND EXTERNAL EXPERTS
UPDATES, MERGERS, ACQUISITIONS, OH, MY! Unless your Company is a startup, you already have an established Quality System in place.  So for most, Quality System improvement is an ongoing challenge. ..
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ARE YOU PLANNING PROPERLY FOR YOUR SYSTEM’S VALIDATION? KEY QUESTIONS TO ASK YOURSELF BEFORE, DURING AND AFTER A SYSTEM IMPLEMENTATION
When implementing a software system, the decisions made during the planning process impact the future for the lifetime of the system.  With a heavy emphasis on the software selection, installation..
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AS OUR WORLD GETS MORE DIGITAL, YOUR SPREADSHEET BASED QUALITY PROCESSES NEED TO ADJUST
/ Rahul Bhatia
In today’s society, with the almost countless number of software applications for quality systems, it’s foolish for any company serious about regulatory compliance and achieving quality within their..
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Transform Selection Value Management Through Advanced Tools and Automation
A Simple Solution for Complex Organizations In our conversations with IT Executives within the Quality Management space, leaders want quick returns on their investments that complement and streamline..
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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
/ Mickey Huber
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
/ Henry Mossi
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
/ Shameica Woollery
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
/ Dhara Kothari
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
/ Rahul Bhatia
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
/ Shameica Woollery
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
/ Rahul Bhatia
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
/ Dhara Kothari
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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7 KEY QUESTIONS TO ASK BEFORE STARTING TO PLAN FOR A SUCCESSFUL M&A DRIVEN DATA MIGRATION PROJECT
/ May Mak
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?
/ Rahul Bhatia
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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Process Stream Partners with Vossom
/ Process Stream
Princeton, NJ – Process StreamTM, a Princeton-based industry-leading quality system solutions consulting company, announced today a strategic partnership with information technology and services..
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PS Recognized by CIO Review for Doing Great Work
/ Bobby Roy
The last few months have been a whirlwind for us at Process StreamTM. It seems like we just announced an award – our selection as one of the top 100 places to work in New Jersey by NJBIZ, which..
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CASE STUDY SPOTLIGHT: IMPROVING REAL TIME PRODUCT LOOKUP, AFTER AN UPGRADE, USING WEB SERVICES
/ Mickey Shah
At Process StreamTM, we are solution seekers. We are continuously presented with issues, and it is our job to find the perfect solution, and then implement it seamlessly.This particular case proved..
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The Truth About Big Data and Big Pharma
/ Mickey Shah
For decades, pharmaceutical development was a slow, resource-intensive process.  While on one level, that hasn’t changed – pharmaceutical development still requires years of research, development,..
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Who Determines the Standard of Quality?
/ Bobby Roy
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. 
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