The DSCSA for Dispensers will be live by November 2020. U.S. based dispensers will only be able to buy or sell any product that has the 2D data matrix barcode and human-readable text format. rfxcel has launched efforts to educate pharmacists, including web pages, flyers, and webinars about the DSCSA requirements. Download this quick guide to DSCSA Requirements for Dispensers. If you want more info about your specific needs, please contact us here.
This Russia serialization guide and white paper look at the massive changes coming to Russia’s supply chain, due to be completed by 2024. The transformation, designed to keep fake and substandard products out of the market, will have a huge impact on the pharmaceutical industry. For example, manufacturers and distributors must connect and comply with the National Track and Trace Digital System, Chestny ZNAK. All medications, including OTC medications, must be serialized, and there are special requirements regarding aggregation and separate serialization requirements for batches. Access this concise, easy-to-understand resource about the Russian pharma regulations.
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EU Annex 11 & 21 CFR Part 11 Compliance Checklist
The United States Food and Drug Administration (FDA) and the European Commission have defined regulations for the conditions under which regulated companies can submit electronic records in lieu of paper documents.
These regulations define the measures that must be in place to ensure the integrity, trustworthiness, and reliability of the electronic records.
The regulations define and require three types of controls:
- Administrative controls, e.g. the definition of policies such as the identification of individuals and non-repudiation of electronic records.
- Procedural controls, e.g. Standard Operating Procedures for using and maintaining the system.
- Technical controls e.g. functions built into the software such as security and access to the system as well as the audit trail
For compliance with the regulation, all three of the above controls must be implemented.
Key Industry Terminology
rfxcel is the leading enterprise software for supply chain and traceability. Major pharmaceutical companies, independent CPOs/CMOs, and wholesalers rely on rfxcel’s expertise in compliance software and support. rfxcel has specialized in core pharmaceutical areas including compliance, tack and trace, serialization and environmental monitoring. Along with a global team and strategic partnership with Verizon, rfxcel has become the #1 independent traceability solution . rfxcel supports its customers in their decision making with rfxcel’s unique 360° approach encompassing capabilities covering global and local markets. rfxcel is committed to its primary mission of supporting customers needs regarding compliance regulations. With absolute visibility into customers’ products, rfxcel is provides value beyond compliance, improving patient safety, customer control and peace of mind.
Seven Secrets of Serialization
Do you know what’s happening to your products out there in the global marketplace? That knowledge could be the difference between security and vulnerability for you and your customers. Traceability has become a key tool for quality improvement in several industries and is a vital weapon in the war against counterfeits. Your supply chain peers tell us that implementing and managing traceability or serialization software is one of their key concerns. It is indeed a challenge but by learning from their experience, and using an experienced vendor, it doesn’t have to be as difficult as you think.
At rfxcel, we design software systems to handle supply chain traceability in fast-moving, highly regulated and fully validated environments like the pharmaceutical industry. In this short white paper, we’ll share some of our design philosophy and some practical things we’ve learned along the way during customer implementations.