ValGenesis Blog
Digitization, synonymous with digitalization, is the process of converting text, pictures (including video), and sound into a digital form that can be processed by computer technology.
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.
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.
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.
