Aegis Analytical Into the Audit Repository Center
The Parenteral Drug Association (PDA) has informed Aegis Analytical Corporation that it has accepted into its Audit Repository Center (ARC) a vendor audit report from a top-five global pharmaceutical manufacturer that is using Aegis’ Discoverant GlobalVantage software suite at two of its manufacturing sites. The inspection was conducted earlier by PDA certified auditors using the standardized process defined in PDA Technical Report #32. The process is widely recognized as one of the most stringent in the industry.
“Passing this audit, and having it accepted into the ARC is a testament to Aegis’ continued commitment to quality,” said Mark Johnson, head of quality for Aegis. “The PDA will be notifying the industry about the availability of the report in its August 2004 Newsletter. We expect that other pharmaceutical manufacturers will want to obtain a copy from ARC, rather the incur the additional cost of performing their own audits of Aegis when they acquire our Discoverant software suite.”
The PDA developed the concept of a global central repository to maintain audit information based upon its Supplier Audit Process Model, in response to FDA requests to standardize the supplier audit process for computer products and services as well as establish a centralized audit information-sharing venue. The model establishes a standardized framework for conducting supplier audits that reduces costs, inconsistencies and redundancy. ARC is the PDA licensed service provider for the repository.
Discoverant GlobalVantage is a manufacturing enterprise software suite that helps companies get single point, direct access to all of the data collected in many locations throughout the manufacturing enterprise, in a user environment that allows decision-makers to quickly translate data into useable intelligence. The unbundled product configuration enables manufacturers to reap additional benefits from already implemented data collection systems while implementing a centrally administered enterprise platform architecture that allows for growth and flexibility. The Discoverant GlobalVantage software suite is validation-ready, and it is built to meet or exceed the requirements for Good Automated Manufacturing Practices (GAMP).
About Aegis Analytical Corporation:
Aegis Analytical Corporation provides manufacturing software and expertise that helps pharmaceutical and biotech companies improve compliance, increase profits and gain competitive advantage. Discoverant, an enterprise software application, gathers data from multiple sources and quickly transforms it into useable intelligence. More information about Aegis Analytical Corporation can be found at http://www.aegiscorp.com . For a streaming video demo of Discoverant, visit: http://www.aegiscorp.com/product/demo.asp .
