Key provisions of the new FDA DQSA regulation include requirements for product identification, tracing and verification. All drug products are required to be encoded with a unique product identifier that must be at the smallest saleable unit and must be able to be verified at the package level standardized numerical identifier. Affected pharmaceutical industry supply chain businesses will benefit from using state-of-the-art software to aid in product traceability, handling and storage. In addition, DQSA mandates conditions for proper detection and response including quarantine for suspect products that are identified as potentially counterfeit, unapproved or dangerous.
Datex Pharmaceutical Software enables full track and trace of serialized and Lot controlled products and provides a comprehensive audit trail and system validation. Datex software provides the ability to quarantine goods and enables multiple simultaneous holds. In addition, Datex Pharmaceutical Edition provides a full suite of QA/QC tools, handles both GS1 barcode processing and RFID and enables product recall tracking and enforcement process. Microsoft based Datex software is powered by workflow, configurable business processes that allow operations to make changes without altering system code. This enables customized business processes at a fraction of the cost of competitive software products and expedited implementation time.
About Datex
In successful operation since 1978, Datex has helped companies operate more efficiently and productively using state-of-the-art technology. Known for developing highly flexible workflow based warehouse management software, Datex WMS is in use by 3PLs, warehousing, distribution and manufacturing operations across the world. Specialists in third party logistics operations and regulated inventory, Datex solutions are highly effective in providing labor and time savings and increased inventory visibility and tracking. Datex solutions are available in web based or on premise editions. For more information on Datex software, hardware and services including EDI and mobile device management, please visit the Datex website http://www.datexcorp.com/.
For more information, please contact Laura Olson, Director of Sales and Marketing at 800.933.2839 ext.243 or via email at lolson@datexcorp.com.
| < Prev | Next > |
|---|
