ValGenesis Blog
Hands-free validation is the ability to perform validation tasks with no or low touch. In some instances, 100% hands-free validation is possible and actually recommended. (Especially relevant during the COVID-19 pandemic where hands-free validation eliminates exposure and transmission.)
In the on-going COVID-19 pandemic, the U.S. Food and Drug Administration has postponed domestic and foreign routine surveillance inspections on a case-by-case basis; it is prioritizing mission-critical inspections that it seeks to conduct with appropriate safety measures in place.
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.
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.
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.
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.
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.
Even in this paperless world, there are still those who continue to use outdated paper-based systems for validation processes.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.
Traditional commissioning and qualification can be very challenging due to the inefficiencies, compliance risk, lack of data integration, inability to adequately track and close out activities.
