RIVA User Group 2017

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By Irene Wasilewski, Application Consultant ARxIUM recently held its annual RIVA User Group at the ARxIUM  office in Buffalo Grove, Illinois. Nineteen hospitals participated in the two-day sessions and discussed maximizing RIVA utilization, RIVA support, regulatory updates and more. Craig Boyce, RPh, one of the Pharmacy Systems Consultants at ARxIUM, organized and led the event. Read more

Categories: Announcements | Automation | Blog | People
Tags: Automated Compounding System | FDA | IV compounding | Pharmacy Automation | RIVA

FDA issues new guidance for dispensers covered under the Drug Supply Chain Integrity Act

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By Nancy Panos The product tracing requirements in sections 582(d)(1) of the Drug Supply Chain Integrity Act took effect for dispensers July 1. However, some dispensers had expressed concern that electronic systems used to exchange, capture and maintain product tracing information would not be in operation by the effective date. But in a July 1... Read more

Categories: Announcements | Blog | Regulatory
Tags: Automated Compounding System | FDA | IV compounding | Pharmacy Automation | RIVAFDA | Validation | Verification

Rewards and Frustrations of SQA

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By Vladimir Shterenberg Software quality assurance (SQA) and testing can be as rewarding as it can be frustrating. Every organization has different ideas on what quality means and what level of quality is needed for their products. You would think the highest quality  possible would be the universal answer, but when it comes down to... Read more

Categories: Blog | Engineering | Regulatory | Software
Tags: Automated Compounding System | FDA | IV compounding | Pharmacy Automation | RIVAFDA | Validation | VerificationFDA | quality | quality assurnace | regulated | Software Design | Software Development

Recent Regulatory Actions: Focus on Quality in Compounding

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by Craig A. Boyce , RPh Over the past month, a number of regulatory changes have occurred surrounding aseptic and sterile compounding.  Some of the significant regulatory actions include:  FDA release of the cGMP Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (7-1-2014)  Massachusetts passage and signing of... Read more

Categories: Blog | Regulatory | Safety
Tags: Automated Compounding System | FDA | IV compounding | Pharmacy Automation | RIVAFDA | Validation | VerificationFDA | quality | quality assurnace | regulated | Software Design | Software DevelopmentAseptic | cGMP | FDA | IV compounding | Manual Compounding | QbD | Quality by Design | Sterile Compounding | USP 795 | USP 797
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