ValGenesis Blog
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.
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.
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.
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.
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.
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.
During validation, a significant amount data and information is generated during the lifecycle of GMP systems that requires data integrity. This data and information includes validation lifecycle data for critical manufacturing equipment, process control systems, laboratory instruments and computer systems.
Unfortunately, the manual process required for creating a Requirements Traceability Matrix is very time consuming, inefficient and not cost effective due to the amount of resources and time required to maintain them during the lifecycle.
Much has been written about validating equipment, instruments, and computer systems. Add articles written about 21 CFR Part 11 to the pile and you become engulfed in a titlewave of information.
