The ConsortiEX family is currently ramping up for the 2019 ASHP Midyear Clinical Meeting, but we want to take a moment to thank all of our customers for their continued partnership on our journey to improve patient outcomes, and in securing the pharmaceutical supply chain. We remain committed to providing health care pharmacists and clinicians […]
We would like to thank all attendees of the ASHP Summer Meetings who stopped by to see us. Having the opportunity to discuss our compliance solutions, in-person, is one that we do not take for granted. We take pride in our commitment to serving industry leaders on their search for simple compliance solutions, while ensuring […]
ConsortiEX will be shipping up to Boston for this year’s ASHP Summer Meeting. We encourage you to stop at Booth 201 for an in-person look at how you can use our intuitive DQSA Compliance solutions to enhance patient safety, ensure quality control and simplify your compliance needs. In addition to our new booth design, we […]
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 […]