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So far ConsortiEX has created 64 blog entries.

Powerful new tools now available to facilitate Total Ingredient Lifecycle Management

As hospital pharmacies and outsourcing facilities strive to enhance patient safety and meet DQSA & DSCSA compliance mandates, these facilities are quickly discovering that new resources are needed to support total ingredient lifecycle strategies effectively. As a result, many in the industry are turning to enterprise resource planning (ERP) to address their needs. But it is important to note that all ERPs are not created equally. That’s why ConsortiEXTM has developed the Pharmacy-Focused ERP, specifically to address the unique business needs and challenges of hospital pharmacies and outsourcing facilities. ConsortiEX’s Pharmacy-Focused ERP takes track and trace capabilities to new levels, making it easier for users to know where every ingredient and product is at any time across the enterprise …from Pedigree to Patient®. Enterprise resource planning (ERP) is broadly defined as the integrated management of core business processes – typically through the use of an integrated suite of software applications. ERPs were originally developed to help an organization [...]

2018-02-14T13:45:45+00:00 February 14th, 2018|blog, ConsortiEX, DSCSA, IV Workflow, Total Ingredient Life Cycle|

House Subcommittee Meeting Points To Compounding Turf War

All drugs should be compounded under suitable quality standards, but who should be ensuring those standards among traditional compounders and outsourcing facilities was debated at the House Energy and Commerce Subcommittee on Health. In written testimony, FDA Commissioner Scott Gottlieb, MD, cited a litany of manufacturing problems at compounding facilities, including mold contamination of the type that caused lethal fungal infections during the New England Compounding Center (NECC) crisis in 2012. In most cases, Dr. Gottlieb testified, these violations are occurring at smaller-scale facilities designated as 503A operators under the Drug Quality and Security Act (DQSA), which was enacted in 2013 to clarify the FDA’s authority over these firms.   Read the full article at: pharmacypracticenews.com

2018-02-07T16:41:07+00:00 February 8th, 2018|503A, 503B, Compounding, DQSA, Industry|

Working Toward Quality Compounded Drugs: A Critical Partnership

This week Congress will hold an important and timely hearing on compounded drugs. The hearing brings stakeholders together to reflect on a law enacted nearly five years ago in response to serious public health incidents. In 2012, a nationwide fungal meningitis outbreak originating from contaminated injectable compounded sterile drugs sickened over 750 individuals and resulted in the deaths of more than 70. This is just one example of several tragedies that prompted Congress to enact the Drug Quality and Security Act (DQSA). Also in response, Federal and state regulators adopted reforms directed at protecting patient safety and helping to ensure safe, quality compounded drugs. We commend Congress for its attention to this critical public health issue and support the ongoing efforts of the U.S. Food and Drug Administration (FDA), states, providers, and practitioners to advance efforts to promote quality in compounded sterile drugs. Read the full post: qualitymatters.usp.org

2018-01-31T13:28:46+00:00 January 31st, 2018|Compounding, DQSA, Industry, USP|

Compounding: FDA Details Policy Priorities for 2018, Finalizes Guidance

The US Food and Drug Administration (FDA) released its priorities for addressing compounded drugs in 2018 after years of developing policies to improve its oversight. FDA Commissioner Scott Gottlieb said the plan will help increase FDA's oversight of compounded drugs while making it easier for certain compounders to transition to becoming registered outsourcing facilities by taking a risk based approach to good manufacturing practices (GMPs) such facilities must adhere to. "FDA is fully committed to implementing these requirements in a way that preserves the legitimate practice of pharmacy and promotes access to these important drugs while protecting patients," Gottlieb said. The plan focuses on five issues related to compounded drugs: Manufacturing standards for outsourcing facilities; Regulating compounding from bulk drug substances; Restricting compounding of drugs that are essentially copies of FDA-approved drugs; Boosting FDA's partnership with state-level regulators that oversee pharmacists and compounders; Developing new guidance on other aspects of drug compounding FDA Statement Read the full article [...]

2018-01-24T10:58:00+00:00 January 24th, 2018|FDA, Industry|

ConsortiEX™’s Pharmacy-Focused Enterprise Resource Planning (ERP) software and services can be an invaluable asset as you plan for 2018.

If you’re not satisfied with your strategic planning efforts for next year in terms of DSCSA compliance, patient safety initiatives, or continuous process improvement, contact us today. Our Pharmacy-Focused ERP addresses the enterprise resource planning process holistically from the pharmacy’s point of view …from Pedigree to Patient®: More easily and efficiently collect, integrate, and manage data. Definitively enhance patient safety and process controls, empowering 503A and 503B facilities to safely prepare, verify, track, and document CSPs. Quickly, cleanly, and accurately streamline DQSA and DSCSA compliance with the support of compliance service experts. Contact us today for more information on #PharmacyFocusedERP or to arrange a meeting. Visit consortiex.com.  

2017-12-11T09:32:33+00:00 December 11th, 2017|blog|

Thanks for stopping by the ConsortiEX™ booth to discover the power of our Pharmacy-Focused ERP.

We want to thank everybody who came to visit our booth at this year’s ASHP Midyear Clinical Meeting & Exhibition. To users who stopped by, we look forward to your ongoing input, and to serving you as responsively and responsibly as possible. To all those looking for help with DSCSA compliance, patient safety, and process efficiency, we look forward to meeting with you soon to show you in greater detail how ConsortiEX and our Pharmacy-Focused ERP can help you address your biggest operational challenges. For more information about #PharmacyFocusedERP, contact ConsortiEX today, or visit consortiex.com.

2017-12-08T03:14:53+00:00 December 8th, 2017|blog|

Discussions with ASHP attendees confirm the importance of our Pharmacy-Focused ERP’s key differentiators.

Booth 501 has been busy at the ASHP Midyear Clinical Meeting & Exhibition. And as we demonstrate our Pharmacy-Focused Enterprise Resource Planning (ERP), industry professionals are confirming the value of the unique foundation we built into this innovative solution. With our introduction of the Assure-Trak® Dynamic Patient Specific module, attendees are finding out for themselves just how convenient, seamless, and comprehensive IV workflow management can be …from Pedigree to Patient®. They are also seeing firsthand how individual applications and modules take on added significance as they collect and integrate data for our DSCSA Compliance as a Service (CaaS). At the same time, they fuel a Pharmacy-Focused Enterprise Resource Planning (ERP) solution – a resource developed specifically for hospital pharmacies, outsourcing facilities, and dispensers, to help achieve DSCSA compliance, enhance patient safety, and optimize process efficiency. To discover the power of #PharmacyFocusedERP for yourself, come to Booth 501 for a demo. Or, for more information, visit consortiex.com today.

2017-12-07T10:34:03+00:00 December 7th, 2017|blog|

We invite you to visit the future of DSCSA compliance, patient safety, and process efficiency.

If you haven’t been to the ConsortiEX™ booth yet at the ASHP Midyear Clinical Meeting & Exhibition, be sure to check out our new website immediately at consortiex.com. It gives you a glimpse of the power that our Pharmacy-Focused Enterprise Resource Planning (ERP) offers hospital pharmacies, outsourcing facilities, and dispensers. Once you’ve seen the site, you’ll want to join us for the demos of our Pharmacy-Focused ERP that are running continuously in Booth 501. See the future in action now: DSCSA Compliance as a Service (CaaS) – Removes the burden of compliance from the dispenser community with comprehensive data collection and product traceability services. Assure-Trak® IV Workflow Management – Seamlessly integrates Batch and Dynamic Patient Specific Compounding capabilities; tracking each ingredient through production to patient administration. Includes the latest addition to the Assure-Trak® offering – our innovative Dynamic Patient Specific module. InsightRX Passive Audit Monitoring – Takes process control to a new level by enabling continuous visual recording for [...]

2017-12-06T08:09:24+00:00 December 6th, 2017|blog|

Discussions with ASHP attendees confirm the importance of our Assure-Trak® IV Workflow Management Dynamic Patient Specific Compounding module’s key differentiators.

Booth 501 has been busy at the ASHP Midyear Clinical Meeting & Exhibition. As we demonstrate our new Dynamic Patient Specific Compounding module, industry professionals are confirming the value of the unique foundation we built into this innovative solution. Configurability – enables users to strike that ideal balance of patient safety and process efficiency in a way that makes the most sense for their organization’s particular needs. Integration – simplifies the ability to collect comprehensive data needed to support DQSA compliance, drive patient safety, and optimize process efficiency …from Pedigree to Patient®. Analytics – facilitate management of key topics ranging from errors and financials, to process efficiency through the use of convenient, easy-to-understand dashboards. The result is a Pharmacy-Focused ERP – a resource developed specifically for hospital pharmacies, outsourcing facilities, and dispensers, to help achieve DSCSA compliance, enhance patient safety, and optimize process efficiency. To discover the power of #PharmacyFocusedERP for yourself, come to Booth 501 for a [...]

2017-12-05T10:37:47+00:00 December 5th, 2017|blog|

Overcome integration issues to achieve DSCSA Compliance.

When we talk with senior management at hospital pharmacies across the country about their challenges surrounding DSCSA compliance, one thing consistently tops the list: Integration. Integration Headaches For some, it’s a matter of resources. For others, it’s technical issues. In many cases, it’s a frustrating combination of the two. There are problems establishing EDI feeds, paper records are time consuming and challenging to incorporate, and drop-shipments regularly don’t arrive with any T3 data. Often, these issues translate to incomplete data collection, a lot of unwanted overtime, and crippling FTE costs. The end result is usually the same: a failure to achieve DSCSA compliance. So, what can you do to alleviate these issues and future-safe your DSCSA compliance solution? More and more facilities are turning to ConsortiEX™ Let the compliance experts at ConsortiEX reduce your regulatory burden with our unique Compliance as a Service (#DSCSA #CaaS) application… focused on pharmacy data needs, so you can focus on patient safety. Our [...]

2017-12-04T10:41:42+00:00 December 4th, 2017|blog|
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