So, now that SP5 is released what is inside?
The following is a list of OSS notes implemented in SCEMSRV SP 5 released on 10th Feb 2014.
Information System and Queries
Integration with Event Management
Quite a few corrections in the SAP EM / TM integration space as well as the Web Dynpro Geo-Map component. Expected event monitoring was improved with 1 new report and an enhancement to the existing one. Performance around processing locked EH's was also improved.
Date: 12th March – 8 sessions starting 8am PST and ending at 3pm PST
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. It’s a virtual seminar 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.
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.
What information needs to be captured? What kind of labeling is needed to document the package? Do we need to cater for unit, pack and pallet levels of packaging? Can the solution handle sequential and random serial numbers? What standards does the solution adhere to in terms of serialization? E.g. GS1 standards.