. (NASDAQ:QADA) (NASDAQ:QADB), a leading provider of
enterprise software and services
, today announced its enhanced quality control framework in
QAD Enterprise Applications
makes it simpler for
and Biotech companies to ensure drug authenticity and product safety.
industry rely on QAD Enterprise Applications to support
throughout their global manufacturing
simplifies the way
can embed quality control processes throughout their production and business operations to meet government imposed regulations while driving innovation.
“QAD customers can track, trace, identify and authenticate prescription products to the smallest saleable unit level,” said Dave Medina, vice president of Life Sciences at QAD. “QAD Enterprise Applications makes it simpler for customers to ensure their products meet their
processes while gleaning insights into how products and processes can be enhanced for greater efficiency and efficacy.”
QAD Allows Customers to Embed Quality Framework with Every Link in their Supply Chain
Using QAD Enterprise Applications, customers can support drug
– electronic records which trace each drug’s chain of ownership from the pharmacy back to the manufacturer. The embedded quality framework in QAD Enterprise Applications is designed to provide complete visibility into the
of a drug or drug lots. It offers comprehensive, centralized reporting and archival history for compliance and exception management. By embedding traceability into the manufacturing process, as opposed to adding serialization to a finished product, QAD’s enhanced quality framework provides companies with visibility across all aspects of their product manufacturing processes. Additionally, QAD enhanced traceability capabilities can link product and manufacturing processes with business transactions across the supply chain including purchase orders, ship notices, and invoices. This can increase supply chain visibility, enhance process optimization and in the case of an adverse event – support effective recall management.
The enhanced controls and audit capabilities, along with eSignature support from QAD, allow companies participating in the Pharmaceutical Supply Chain to meet regulatory requirements such as the Federal Prescription Drug Marketing Act (
). The fully embedded quality framework in QAD Enterprise Applications offers Biotech and Pharma companies and packagers a complete solution to boost supply chain management. By using their enterprise resource planning (ERP) system to enforce the integration of a quality framework into their operations, life sciences companies can ensure the consistent, regulatory compliant execution of their business processes without the disruption of third-party or paper-quality systems.
Product Diversion and Drug Counterfeiting
An effective enterprise in the life sciences industry thrives on delivering innovative, quality products that help improve patients’ lives. QAD’s enhanced quality framework is designed to support drug authenticity and safety with track and trace capabilities that can also support measures to detect product and public safety issues. The growing global problem associated with counterfeit drugs, including those sold with a false brand name, generates an estimated $75 billion in revenue annually, according to The National Association of Boards of
. To date, governments have struggled to safeguard the distribution of legitimate drugs and crack down on counterfeits.
for Mitigating Risk
In the United States, California has been leading the charge with their ePedigree law due to take effect in 2015, which may prevent the diversion or counterfeiting of drugs by requiring the serialization and ePedigree of pharmaceutical drug packages. European regulations, too (in Turkey, France, and elsewhere) are focused more on product authentication, and are driving companies to pursue item-level serialization. Until effective public policy is implemented, the pharmaceutical industry can move towards compliance by implementing authentication capabilities such as those offered by QAD Enterprise Applications.