Customer Spotlight | RC Outsourcing

In the latest edition of the ConsortiEX Customer Spotlight series, where we highlight the efforts of our partners in ensuring patient safety and regulatory compliance. We spoke with Kim Beight, Quality Director, at RC Outsourcing a 503B Outsourcing Facility in Ohio.

This Spotlight focuses on the impact Assure-Trak® has had on their compounding operation, and how it can serve other 503B compounders. This spotlight showcases the truly unique scalability of Assure-Trak®, the only IV Workflow Management System serving both 503B and hospital-based compounding initiatives.

Read the full transcript below.  

Transcript:

1. Historically speaking, what is the scope of the operation at RC Outsourcing?
   
   
   1. We are a 503B Outsourcing Facility that opened in October 2015, as the first outsourcing facility in Ohio. We ship re-packaged and compounded drugs to 39 states, and our list continues to grow as we navigate the ever-changing regulations and oversight by the Food & Drug Administration (FDA).
2. What motivating factors led to the implementation of Assure-Trak®?
   
   
   1. Until we implemented Assure-Trak®, we were very old school, everything was on paper. During a recent FDA inspection, we took on the daunting task of digging through box after box of files, then making hundreds and hundreds of copies; the time came to start working smarter, not harder.
      
      Now, with Assure-Trak®, our batch records are all electronic. It was extremely easy to retrieve the requested records during our last inspection. We were complimented several times by our inspector on how quickly we gathered everything for her.
3. In what ways has Assure-Trak® improved operations?
   
   
   1. Assure-Trak® has helped all personnel to get on the same page. It has made everyone accountable for their work and actions. The system has organized our processes and helped us to raise our compliance to the next level. Most importantly, our documentation is all in one place where we can see the whole story - and the FDA can too.
4. What features of Assure-Trak® stood out to you, as a 503B Compounding Facility? Do you believe other 503Bs would benefit from Assure-Trak®
   
   
   1. The labels were a winner for us; and, like mentioned before, having information all in one place is huge. I believe other 503B facilities would benefit from Assure-Trak® just by virtue of how easy it is to use. Also, larger 503B facilities could take advantage of the Assure-Trak^® EXchange Ordering Platform.
5. How has Assure-Trak^® helped you to meet compounding regulations?
   
   
   1. Assure-Trak® has helped us in so many ways. Having the ability to assign specific responsibilities to each employee was important. Label reconciliation, attaching lab results to batch records, being able to include compounding notes, and most importantly having everything date and time stamped, has helped in investigating and reporting. The list goes on....
6. Have you faced any regulatory audits or inspections since implementing Assure-Trak^®; if yes, how did Assure-Trak support your audit/inspection response?
   
   
   1. The FDA visited in September. As mentioned above, we were complimented several times on how quickly we gathered information and documents.
7. In what ways has Assure-Trak^® eased your concerns around regulatory compliance?
   
   
   1. Our concerns have been eased a great deal. Assure-Trak^® has made everything we do a step-by-step process, that is easily followed; because of how it operates, no step can be skipped or ignored, and everything must be checked and verified. It is a secure system and the fact that nothing can be deleted or tampered with is perfect.
8. What experience, if any, do you have with the ConsortiEX Support team?

A. From day one we have had a great relationship. ConsortiEX knew exactly what we needed and when we made suggestions or had requests, they were always open to hear us out and try something new. We have no doubts that we made the right decision to implement Assure-Trak^®. 

Thank you for reading this edition of ConsortiEX Customer Spotlight’s, don’t forget to check out past spotlights to learn more about the impact of Assure-Trak^®.

If you have specific questions around how Assure-Trak^® can improve your compounding operation, please contact us today!