ValGenesis Blog
The episode "Digitization Of Validation For Effective Virtual Regulatory Inspections", originally broadcast on IVT Network's Voices in Validation podcast won the 2021 Voices in Validation Podcast of the Year Award. The episode featured Dr. Ajaz Hussain, Dr. Alton Johnson and Steve Thompson.
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.
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.
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.
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.
The deadline to comply with the EU General Data Protection Regulation (GDPR) is May 25, 2018. Are you ready? For Life Science companies you may be readier than you think. The key is to leverage the controls and practices that you already should have in place.
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.
