Author:
Bridget McCrea
Category:
Enterprise Resource Planning (ERP), Community

Pharma Braces for New Regulations that Test ERP’s Quality, Manufacturing Tools

Published: January 29, 2015

Tribridge's Jennifer Stango, ERP Director, joins the discussion on how the FDA regulation changes, specifically the Drug Quality and Security Act (DQSA) and the Compounding Quality Act, impact pharmaceutical manufacturers and how their ERP systems will determine if they will have the capability to meet these tracking guidelines.

“'In most ERPs you can track all the way from the raw materials that go into the drug right to the finished good that’s actually made and used,' Stango says. 'Now we’re taking that a step further, and actually looking at every time that bottle or package moves or changes hands. And while smaller firms that only ship a few bottles can still do this using their existing manual systems, she notes, larger firms that produce higher volumes need flexible ERPs that can handle serial lot control and validation."