Life Sciences organizations have to cut the cost, time and complexity of bringing safe and effective products to market and at the same time must also comply with increasingly stringent and constantly changing global and regional regulations.
To meet these challenges they need a software solution that can both increase collaboration and reduce cycle times for many processes across multiple lines of business.
The new Pegasystems solution automates and optimizes key business processes to support FDA 21 CFR Part 11, allows organizations to connect to electronic document management systems, and quickly generates regulatory PDF forms such as MedWatch 3500A and FDA 1571.
It also enables auditable content distribution including sponsor, healthcare professional and regulator correspondence.
Pegasystems Life Sciences Industry Solutions principal Melonie Warfel said now, more than ever, it’s crucial for life sciences organizations to extend the value of their existing systems, so they can both ensure compliance and exploit new market opportunities at the speed of their business.
"Far too often, there are execution gaps that negatively impact the levels of efficiency and transparency they need to solve their business problems," Warfel said.