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. Since our foundation, […]
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. ProntoPump is a new peristaltic pharmacy pump that is used for pooling, reconstitution, filling or transfer of any fluid in sterile, and non-sterile, environments, […]
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. At ConsortiEX, we have promised our customers that our DSCSA compliance solution will always be ready for upcoming deadlines and any FDA guidance. […]
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 drugs, such as those that are stolen […]
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. Raps writes, “The guidance updates a draft version released in 2016 and has been revised to include additional information on the agency’s current thinking on data integrity to […]
The FDA has issued a guidance to 503B facilities regarding Current Good Manufacturing Practice (gCMB) Healthcare Packaging explains: “A Dec. 10 statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram focused on the importance of ensuring compounded product quality. FDA noted that it continues to implement its 2018 Compounding Priorities Plan as part of […]