Two sides to the Same Coin: Qualification vs. Validation

Qualification vs. Validation The concept of qualification vs validation has been a topic permeating the pharmaceutical industry. As discussed in FDA’s Guidance for Industry Process Validation:..

Important Changes from the eMDR from Our Solutions Experts

Medical Device Post Market Surveillance Coding The FDA eMDR eSubmission Gateway and the EU MIR forms are implementing new changes to fields and structures to harmonize codes on the IMDRF code sets...

ICYMI: 7 Must-Have Quality KPIs (+how to build them)

In Case You Missed It!

Streamlining Quality Management System Documents

The “M” in QMS is a double-edged sword. The Quality Management System needs to control and manage the GMP systems, operations, and processes that keep an organization functioning at a high standard..

Software Innovation Q&A Session #2 (Jason Voss): Developing archiveIQ

Our StreamLABS product innovation team has been hard at work developing a new, end-to-end, data archival solution. In Q&A session #2, we chat with Chief Solutions Architect of streamLABS and the..

Software Innovation Q&A Session #1 (May Mak): Developing archiveIQ

Our StreamLABS product innovation team has been hard at work developing a new, end-to-end, data archival solution. We got a chance to sit down with the driving forces behind the design concepting and..

LEADERSHIP Q&A: A Race to the EU MDR Deadline with Mickey Huber

The EU is flexing regulatory muscles, and the new Medical Device compliance deadline is January 1, 2020. With only a few months to go, it is of the utmost importance to assess your situation..

LEADERSHIP Q&A (SESSION #2) Digital Transformation & The Quality Ecosystem

Our industry is embarking on an exciting new frontier. Digital transformation and quality 4.0 are driving organizations to evolve and adapt technologies, people and processes throughout the journey.

WHAT PROCESS STREAM IS SEEING IN DIGITAL TRANSFORMATION & THE QUALITY ECOSYSTEM

Our industry is embarking on an exciting new frontier. Digital transformation and quality 4.0 are driving organizations to evolve and adapt technologies, people and processes throughout the journey.

The Move to Quality 4.0: Analytics & 'Big Data'

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..

The Move to Quality 4.0: Understanding Emerging Technology Use-Cases

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.

The Move to Quality 4.0: Technology-Enabled Solutions

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.

The Move to Quality 4.0: digital Transformation

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.

THE MOVE TO QUALITY 4.0: THE PROCESS STREAM PERSPECTIVE

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.

What to Expect at Sparta Connection 2018

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..

How the Right Business Tools Let You Focus on Data Analytics

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..

The Publisher/Consumer Bottleneck: How Data Warehouse Models Limit Your Organization

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.

PMO Methodologies: An Exploratory on Project Planning and 'Getting Across the Finish Line'

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..

Management Strategies Series - Volume 1: Dealing with Unplanned Demand in Your Quality Ecosystem

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..

LOOK ABOVE AND BEYOND THE IMPLEMENTATION: THE IMPORTANCE OF HYPERCARE AND ONGOING SUPPORT

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..

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. ..

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..

AS OUR WORLD GETS MORE DIGITAL, YOUR SPREADSHEET BASED QUALITY PROCESSES NEED TO ADJUST

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..

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..

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..

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,..

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..

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,..

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..

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..

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..

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..

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..

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..

7 KEY QUESTIONS TO ASK BEFORE STARTING TO PLAN FOR A SUCCESSFUL M&A DRIVEN DATA MIGRATION PROJECT

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..

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.

Process Stream Partners with Vossom

Princeton, NJ – Process StreamTM, a Princeton-based industry-leading quality system solutions consulting company, announced today a strategic partnership with information technology and services..

PS Recognized by CIO Review for Doing Great Work

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..

CASE STUDY SPOTLIGHT: IMPROVING REAL TIME PRODUCT LOOKUP, AFTER AN UPGRADE, USING WEB SERVICES

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..

The Truth About Big Data and Big Pharma

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,..

Who Determines the Standard of Quality?

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.

Insights

The Latest from Our Expert Consultants

Categories

Insights

The Latest from Our Expert Consultants

Categories

Subscribe to streamINsights