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