ValGenesis Blog
Philips needed a digital validation lifecycle management system that could standardize its paper-based computer system validation (CSV) efforts across multiple geographies.
Since implementing ValGenesis VLMS, the company has seen a 35-45% reduction in validation/qualification cycle time and a 30-40% increase in efficiency gains for CSV; and a 25-30% reduction in validation/qualification cycle time and a 30-35% increase in efficiency gains for EQ.
“Technology can only point us in the right direction,” Prem says, “but the onus of using and harnessing it, of bringing better patient outcomes is really the responsibility of pharma organizations and manufacturers who must step out and take things to the next level.”
Roche/Genentech eliminated 50% of the non-value-added tasks employees were forced to perform in the paper-based system, allowing them to reallocate resources to prioritize innovation and get products to market sooner with less effort.
“CPV is a broader concept because it gives you a more holistic picture of overall product performance over a period of time. While both APR and CPV give you an indication of product performance, the current situation in most companies is that they remain disconnected".
Many of Theragent’s new employees were frustrated with the paper-based systems they were forced to work with in their previous companies. The switch to digital wasn’t quick enough for them.
The evolution from compliance to a proactive learning system focused on patient quality outcomes involves overcoming several barriers, many of which are tied to the limited adoption of advanced technology and digital tools.
