SMARTRISK was developed as a response to the EU guidance that was published in 2015 regarding excipient risk assessment for medicinal products to provide a way of performing the risk assessment in a compliant manner, but that was easy for the user.
PharmaLex expert Kate Coleman explains what SMARTRISK actually is.
Kate is a Quality professional with 18 years experience in the Pharmaceutical Industry across several platforms including Biologics, Sterile Fill Finish, High Potency oncology and Solid Oral Dose products. Kate is an SME in Quality Risk Management and works with her clients to deliver and remediate QRM programs providing efficiency and clarity across the product lifecycle.
Check out https://www.pharmalex.com/smartphlex/smartrisk/ for more information.
