Since our foundation, ConsortiEX has aimed to deliver highly innovative IT systems for hospitals and their affiliated networks. A crucial part of that goal was a seamlessly integrated solution that would satisfy the need for both anticipatory batch and patient specific compounding. We have achieved this with our Assure-Trak® IV Workflow Management application for both […]
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 […]