Supply Chain Article

Matthew M. Lowe’s picture

By: Matthew M. Lowe

It’s human nature to resist change, and the life sciences industry is not exempt from a change-averse mindset. The proof: Life science organizations (LSOs) lag far behind counterparts in other sectors in implementing digital technologies that are designed to streamline business and manufacturing processes.

Richard Ruiz’s picture

By: Richard Ruiz

When a customer asks to see your layered process audit (LPA) documentation, will you be ready? For many manufacturers, the answer is no.

Instead of having proof of an effective audit process, many companies are left scrambling for data that show low audit compliance and few actual results. Unfortunately, poor audit processes are enough to fail a customer audit, which could put your key contracts at risk.

Rachel Mann’s picture

By: Rachel Mann

With medical cannabis being legal in Canada since 2002, and recreational use becoming legal in 2018, Prime Minister Justin Trudeau’s promise to his country has caused a storm.

Alla Katsnelson’s picture

By: Alla Katsnelson

In August 2011, a can of Great Value peas joined the nonperishables in my pantry, one of several panic purchases as Hurricane Irene barreled toward my home on the northeast U.S. coast. But the emergency passed, and the can, with its unassuming blue-on-white outline font, remains on my shelf seven years later.

Its continued presence raises a dilemma in the form of a clearly legible stamp: “BEST BY 12/31/14.” Should I toss it? Can canned peas go bad? How would I know if they had?

Tom Taormina’s picture

By: Tom Taormina

Outsourcing is historically one of the most misunderstood concepts in quality management system (QMS) implementation and operation. Prior to ISO 9001:2015, the requirement for outsourced processes was limited to a few sentences in the standard’s clause 4.1. This article will present, through a case study, how understanding the implications that outsourcing, according to ISO 9001, is of key importance for a company.

Multiple Authors
By: Claire Harbour-Lyell, Antoine Tirard

Born to a Dalit family, Megha was raised in Southwest India and learned English at her convent school. As a child, she aspired to be a fashion designer or a cardiologist, but her parents insisted that she become an IT engineer. After four years of higher education, Megha found a job in the booming technology sector.

Kelly Kuchinski’s picture

By: Kelly Kuchinski

Imagine building a brand over decades. Hundreds of millions of dollars invested in design and development. Sponsorships with celebrity athletes and professional and college teams. Leading-edge marketing making your company one of the top 20 brands in the world. It only takes one incident to unravel all this investment.

NIST’s picture

By: NIST

Engineers at the National Institute of Standards and Technology (NIST) needed a way to secure smart manufacturing systems using the digital thread, so they turned to the new kid on the block... blockchain, that is.

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests.

Taran March @ Quality Digest’s picture

By: Taran March @ Quality Digest

It’s been a year and a month since Stephen McCarthy switched C suites, moving from Johnson & Johnson, where he served as vice president of quality system shared services, to Sparta Systems, where he’s now vice president of digital innovation.

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