Microbia and Ranbaxy could use this tool? Must be PURE GENIUS behind these companies.........
( revelink.com )
Paper Conversion Solved for Pharmaceutical and Biotechnology Companies With Offering From Aegis and Revelink
Tuesday February 25, 11:15 am ET
PREP Enables Manufacturers to Meet Federal Compliance Regulations and Make Better-Informed Decisions
LAFAYETTE, Colo., Feb. 25 /PRNewswire/ -- As life sciences companies search for ways to improve manufacturing and comply with industry regulations, a tall obstacle stands in their way -- ubiquitous, paper-based processes, systems and data. Today, Aegis Analytical Corporation, a leading provider of software solutions and expertise for pharmaceutical and biotechnology manufacturers, and Revelink, Inc., a provider of compliance solutions for regulated industries, announced a partnership to enable life sciences companies to quickly capture and manage paper records.
Industry experts estimate that "manufacturers still have between 80 to 90 percent paper-based processes in validated operations." (Source: Roddy Martin, The AMR Research Report, July 2001.) In 1997, the Federal Drug Administration (FDA) established 21 CFR Part 11 to ensure the accuracy and security of manufacturing data. One goal of the rule is to make electronic records as secure as paper versions and protect them from mistakes, fraud and destruction. Since the FDA requires double-blind entry to validate data and ensure the integrity of all manufacturing records, conversion to electronic format is a costly, time-intensive process.
Aegis and Revelink developed PREP (Paper Record Entry Program) to solve this specific problem for the life sciences industry. PREP combines Aegis' powerful data analysis technology, Discoverant 1.7®, with Revelink's comprehensive compliant document management capabilities. PREP includes a flexible data entry form designer within a 21 CFR Part 11-compliant document management system. The program allows for single- or double-blind entry with field value validation accomplished while the data is being entered. The final, FDA compliant, electronic documents are then exported into Discoverant-compatible database tables.
By capturing paper records and validating the data, PREP eliminates potential errors that can occur when manually plugging thousands of values into spreadsheets as required by other decision-making tools. The end result is high data integrity and more secure records, in addition to more efficient FDA reporting. PREP is now generally available.
"Pharmaceutical companies need tools that simplify integration and simultaneously deal with FDA Part 11 requirements for security and integrity of electronic data and signatures," said Roddy Martin, AMR Research Service Director, in the August 29, 2002, AMR Research Report, Part 11 Integration of Pharmaceutical Operations Data: Systems Do Exist. "Compliant integration of 21 CFR Part 11 data from pharmaceutical operations is becoming increasingly vital as manufacturers look for ways to improve productivity and comply with regulatory demands through integrated manufacturing operations and tighter process control."
More detailed information on 21 CFR Part 11 and its impact on pharmaceutical manufacturers can be found in a white paper from industry expert Olin Thompson at aegiscorp.com .
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 aegiscorp.com .
About Revelink, Inc.
Revelink, Inc. develops and delivers compliance solutions to the regulated life sciences industry. Architected for rapid deployment, scalability, and low validation burden, Revelink's compliance suite includes software solutions for Document Management (cDMS), Lifecycle Management (cLCM), and Quality Management (cQMS). More information about Revelink, Inc., can be found at revelink.com .
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Source: Aegis Analytical Corporation |
