Datex Software Now Includes Features to Facilitate New FDA DQSA Regulation Compliance
Clearwater FL (PRWEB) August 31, 2014 -- Datex Pharmaceutical Software now includes a suite of features which enables compliance of the new FDA regulation, the Drug Quality Security Act (DQSA). The FDA Drug Quality and Security Act (DQSA) was signed into law in late 2013. Established to address threats to patient safety and security, the new federal law will improve the effectiveness of pharmaceutical product recalls and provide a single nationwide policy. DQSA affects operations throughout the supply chain including: pharmaceutical manufacturers, re-packagers, wholesale distributors, third party logistics providers and dispensers.
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(at)datexcorp(dot)com.
Angela Cox, Datex Corporation, http://www.datexcorp.com, +1 727-400-3633, [email protected]
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