March 18, 2020
Changing mindsets from compliance-centric to quality-focused isn’t easy. It’s possibly the most difficult change to make, but it’s necessary for a quality culture to take hold.
February 12, 2020
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
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
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
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.
November 29, 2019
The meaning of quality of life sciences products gets confounded in pre-market toxicology and human clinical trials. Real-world outcome feedback, an essential driver for improvement, is beginning to improve with advances in electronic health records and data analytics. Increasing weight on outcome-based reimbursement, pay for performance, and value-based pricing is transforming how the sector is developing, marketing, and improving products.
June 7, 2019
Even in this paperless world, there are still those who continue to use outdated paper-based systems for validation processes.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.
May 9, 2019
Hello and welcome to the first installment of our new blog series, “Managing Cybersecurity in a SaaS Environment.” Throughout the year, we will be posting articles on various cybersecurity topics.
April 25, 2019
As the folks at the FDA continue to improve the speed of their review/approval processes, many organizations in the life sciences and pharmaceutical industries are working hard to implement new technologies to efficiently manage their validation needs.