February 9, 2021
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.
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Even in this paperless world, there are still those who continue to use outdated paper-based systems for validation processes.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.