Most organizations deal with the shipment of goods in to and out of their premises. With the increasing demand for a better customer experience it is a challenge to provide a high level of customer service when parts of your supply chain fall somewhat out of your “sphere of influence”. Sure, through contractual obligations, you can try and force your suppliers and carriers to behave in a certain way but as the old saying goes “stuff happens!”. If the supply chain breaks down outside of your 4 walls, are you aware of it? Do you have enough time between when you find out about the issue and the time needed to correct it? Do these issues in the supply chain cause disruption and potentially lead to lost customers and sales?
The key to remedying this issue was discussed back in the 1990’s and was termed Supply Chain Event Management – Give me the ability to monitor the events occurring THROUGHOUT my supply chain as and when they occur – Let me measure these events against what I had expected to occur and if it differs in any way let me know so that I can take proactive measures to correct it. Continue reading →
I often get asked how we can leverage SAP Event Management functionality. This is a great question because, after all, SAP EM is a tool that is delivered with SAP to provide end-to-end business process visibility and exception management. Much like you would leverage a workflow solution to enforce certain activities to take place at the right time by the right people, SAP EM is a tool to provide for this process visibility and exception management. Every Enterprise Architect should have SAP EM as an option in their toolkit. Continue reading →
Starts tomorrow March 12th. 8 sessions packed on useful information on DSCSA, SAP OER / AII / GBT / EM, Implementation experience… Focused specifically on the Pharma industry and a second track on the SAP solutions provided for Serialized and Batch Track and Trace.
What does the Drug Quality and Security Act of 2013 (DQSA), formerly referred to as HR 3204, mean to you?
On November 27, 2013 H.R. 3204 was signed into US Federal law as the Drug Quality and Security Act of 2013 (DQSA). Among other things, the new law will impact the way prescription drug trades are documented in the United States and preempt state laws for drug traceability, including California’s e-pedigree law. This one hour session outlines the requirements of the DQSA, Title II, referred to as the Drug Supply Chain Security Act (DSCSA).
Congress enacted the Drug Quality and Security Act of 2013 (DQSA), formerly referred to as HR 3204, in November 2013 and it starts to take effect in a significant way in January 2015. You should be planning to attend the 1st annual Serialized Track-and-Trace Seminar on 12th March, 2014. This is a virtual event that allows you to attend the sessions from the comfort of your own home or office, yet you still have access to all the content and experts that you would expect from a live event. It’s a truly unique and valuable opportunity for those focused on these latest changes in legislation for the Pharma industry. Continue reading →
If you are a pharmaceutical manufacturer, repackager, wholesaler or dispenser of drug products then the DQSA Law (H.R. 3204) passed on November 27th 2013 is applicable to you. It supersedes all current state laws including the California e-Pedigree law. In this article I will focus on the timelines applicable for a drug product manufacturer. In future articles I will deal with the timelines for the other supply chain players. Continue reading →