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Posts about Pharma 4.0

Blog Home | Tag: Pharma 4.0
June 21, 2022

The Pharma 4.0 Vision for Manufacturing Intelligence

Digital validation and automation meet complex product lifecycle needs but they're only enablers to the intelligence at the heart of manufacturing activity. Learn how ValGenesis is expanding its product vision beyond validation toward a holistic manufacturing intelligence platform.

April 3, 2020

The Business and Buzz of IoT in Validation

The Internet of Things (IoT), sometimes described as an interconnected enterprise system, creates quite the buzz in business circles today. Connecting data, information, and knowledge certainly carries the potential power of creating intelligence to leap ahead of the competition.

February 12, 2020

FDAs Computer Software Assurance (CSA) – Part 1 of 3

With traditional CSV, too much focus is on documentation. The amount of time and effort put into documentation consumes significant resources and sacrifices critical thinking. CSA inverted this upside-down way of thinking whereby focus is placed first on critical thinking, then assurance needs, then finally testing and documentation.

January 21, 2020

Why Validation projects fail

Many validation projects invariably overrun budgets and fail to meet schedules. This conundrum often results in management eyeing validation costs suspiciously. Under cost containment pressures from management, there is a tendency to cut corners which results in an increased compliance risks.

December 19, 2019

Digital Transformation Pharma 4.0 Impressive technology, but what about people

This current era of biopharmaceutical manufacturing is a most challenging and exciting time for our industry. Technology breakthroughs, intensifying competition, and continually rising performance expectations from patients, stakeholders, pressure from government bodies for cost reduction, and regulators necessitate rapid change in execution.

December 13, 2019

Genesis of Validation: Personal, Professional And Public

Validation is personal, professional, and public! Going “paperless” is then crucial to progressing on the 2020-2030 journey. So it is clear, on reflecting on the early days of ValGenesis –why the name “ValGenesis” is so appropriate for a 100% Paperless Validation Lifecycle Management System.

June 7, 2019

10 reasons to adopt paperless validation

Even in this paperless world, there are still those who continue to use outdated paper-based systems for validation processes. Sadly, these holdouts are unnecessarily creating various pain points for such ventures, which cost their parent organizations an unbelievable amount of wasted time and money. Validation technology (especially Cloud-based solutions) can now provide paperless options that fully eliminate the many problems and time-killers that haunt those who still use paper.