OSIsoft Sets New Reporting Standard With RtReports; Proven Solution Tested by Leading Pharmaceutical Companies
OSIsoft, Inc., the leader in Real-time Performance Management (RtPM) software, today announced the availability of RtReports, the first solution to produce on-demand reports that include both real-time and historical data. Designed to meet increasing compliance and regulatory obligations, RtReports provides batch process manufacturers with a powerful, easy-to-maintain solution for accessing process information — anytime, anywhere. Leading pharmaceutical companies, including Baxter Healthcare Corporation, Mead Johnson and Roche Ireland Limited have been using RtReports in a pilot program to validate the product in operational use.
“Quickly delivering safe, high-quality products that comply with complex government approvals is critical to success in the pharmaceutical industry,” said Dick Fitzgerald of Roche Ireland Limited. “RtReports is the only reporting solution we have found that meets our agile data collection and storage needs for multiple departments to ensure fast, accurate batch-record measurements.”
RtReports delivers a comprehensive package for managing multiple compliance and reporting needs — from FDA Regulation 21 CFR Part 11, or Compliant Batch End reports, to unique reporting requirements of an individual organization. Leveraging OSIsoft’s PI System, users can generate 21 CFR Part 11 compliant reports through a complete, end-to-end system — from powerful data collection, querying and configurable report building, to report sign off.
“Compliance accountabilities are spread across functional executives, such as regulatory affairs, quality, operations, Research and Development (R&D), and manufacturing and product supply operations. Even newly appointed Corporate Compliance Officers (CCOs) are stuck in the quagmire of reacting to tactical commitments,” said Roddy Martin, vice president of research, in an AMR Research Alert dated April 22, 2004. “However, not doing something about the fragmentation has a price. Inspection approaches add cycle time, business risks and structural waste to already low levels of Pharma productivity. It takes 30 to 50 days to resolve nonconformance investigations in manufacturing.”
With RtReports, all data are maintained in their original fidelity in the PI System to ensure audit-ready reporting. Specifically, the PI System stores raw process instrument data in the PI Archive, batch cycle activity in the PI Batch database, and the report configuration (with versioning and effective dates) in the PI Module database. The PI System also stores and maintains the product and specific recipe limits (with versioning and effective dates) in the PI ProcessPoint database. This fundamentally enables RtReports to regenerate the exact original report results for any batch cycle stored in the system without additional programming. As a result, libraries of report queries are easy to build, significantly reducing future reporting time.
RtReports simplifies the batch-auditing process with the use of standardized manufacturing documentation. Using a powerful query engine, RtReports identifies process exceptions in real time or anytime after the batch run is complete. Dynamic reporting capabilities enable automatic report generation of details by using built-in trending, tabular data output and statistical features.
The solution is flexible and easy-to-configure, enabling authorized individuals within a company to visualize and share reporting data in a secure, customized environment. Users gain web-based access to reports through OSIsoft’s RtPortal, providing the ability for reports to be electronically approved. RtReports can also be integrated into current workflow systems or legacy reporting packages to provide a single source of data.
RtReports enables batch process manufacturers to:
— Generate tamper-proof reports with an audit trail of all meta data and user security changes;
— Automate raw data auditing and provide a permanent manufacturing record;
— Integrate all PI System applications and other data sources;
— Reduce system validation costs with simplified reporting;
— Speed time-to-market with electronic signatures for faster release of batches.
“With RtReports, OSIsoft has created a smart, easy and secure solution for generating reusable reports, setting a new standard in reporting,” said Tony Fenn, product manager for OSIsoft. “No other solution on the market can generate fast, detailed reports that enable pharmaceutical manufacturers to easily comply with regulations without additional programming.”
About OSIsoft
OSIsoft delivers the world’s leading operational Real-time Performance Management (RtPM) platform. This platform crosses enterprise boundaries to incorporate and visually display user-configured, real-time operational event data, fueling the business decision cycle to drive collaboration and intelligent actions. More than 10,000 OSIsoft customers worldwide use RtPM as the foundation to continuously improve the performance of their organization. RtPM unlocks the hidden value in these systems by delivering high-fidelity information for real-time action. The company’s fierce commitment to customer satisfaction is unparalleled in the industry. For more than 20 years, customers have trusted OSIsoft’s breakthrough products, including the PI System, to preserve and harness real-time data. Only OSIsoft’s RtPM platform provides an end-to-end experience–from problem identification, through cause-and-effect determination and ultimately to resolution/implementation–supporting both tactical and strategic modes of operation.
Founded in 1980, OSIsoft Inc., is headquartered in San Leandro, Calif., with operations worldwide and is privately-held.
