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.

Insights

The Latest from Our Expert Consultants

Categories

Insights

The Latest from Our Expert Consultants

Categories

Subscribe to streamINsights