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[...]
ConsortiEX is proud to announce T3 verification, the newest feature to be added to our DSCSA Compliance as a Service (CaaS) module. The T3 Verification process gives pharmacies maximum visibility to all T3 transactions, both electronic and paper, received by their pharmacy.
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The FDA recently issued a draft guidance regarding verification* systems in accordance with the Drug Supply Chain Security Act (DSCSA).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.
At ConsortiEX, we work diligently to create solutions designed specifically for the unique needs of health system pharmacies. The result is our Assure-Trak® IV Workflow Management Dynamic Patient Specific Compounding application a dynamically configurable IV Workflow solution to enhance patient safety and optimize[...]
Just last week, ConsortiEX proudly announced our new InsightRX Passive Audit Monitoring module.
Understanding the rules and regulations behind DSCSA Compliance can be a daunting task. As deadlines pass, the FDA regularly updates what it means to be compliant. ConsortiEX is proud to offer DSCSA Compliance as a Service (CaaS). Our CaaS module removes the burden of being compliant from the dispenser community with[...]
Today, cost and quality issues surrounding compounded sterile preparations (CSP’s) have nearly every major health system investigating what it takes to re-insource production. Most are looking at a hub and spoke approach, where their central-fill Batch Compounding can support the CSP production needs of all the[...]