The FDA recently issued guidance on the definition of Suspect and Illegitimate Products, set forth in the Federal Food Drug and Cosmetic Act1. This guidance aims to assist trading partners in putting systems in place to identify and handle suspect and illegitimate products, meeting Drug Supply Chain Security Act[...]
We want to thank all of those who were able to attend the 2019 ASHP Midyear Clinical Meeting. Being able to discuss your feedback and concerns, in person, is invaluable to us. 2019 was a very busy, yet exciting, year for the ConsortiEX family. We hope it was for you as well.
As the 2019 ASHP Midyear Clinical Meeting approaches, we want to take this time to announce the integration of our Assure-Trak® Compounding Management System’s Batch Compounding module with ProntoPump by ProntoPrep.
As we inch closer to the 2019 ASHP Midyear Clinical Meeting we want to give a glimpse of what we have in store, not only for ASHP, but for 2020 and beyond.
Many hospitals struggle to achieve optimal compliance with the Drug Supply Chain Security Act (DSCSA). The challenge to comply seems to come from an incomplete or inaccurate understanding of the regulations, which is understandable given the Act’s complexity. DSCSA was put in place to protect consumers from harmful[...]
The FDA released a finalized questions and answers guidance on data integrity compliance. The FDA guidance adheres to requirements under current good manufacturing practice ( cGMP) for drugs and biologics.
The FDA has issued a guidance to 503B facilities regarding Current Good Manufacturing Practice (gCMB)
The FDA recently issued a draft guidance regarding verification* systems in accordance with the Drug Supply Chain Security Act (DSCSA).
We want to thank everybody who came to visit our booth at this year’s ASHP Midyear Clinical Meeting & Exhibition. We always appreciate the opportunity to show off our products to the people who need them most.
Just last week, ConsortiEX proudly announced our new InsightRX Passive Audit Monitoring module.