InnaPhase Releases Automated Validation and Quality Assurance Tools; QA Toolset Reduces Time and Effort Expended by Internal and External Regulatory Auditors.

PHILADELPHIA--(BUSINESS WIRE)--Nov. 12, 1999--

InnaPhase Corporation, a leading provider of software tools and technology for early drug development teams, today announced the release of a Quality Toolset for helping internal and external auditors to obtain fast installation validation, full data traceability reports and computational method tracking across the range of InnaPhase products.

The Validation Agent(TM) helps companies comply with internal and regulatory guidelines for the installation validation of Kinetica 2000(TM), InnaPhase's powerful new PK/PD data analysis product. Previously in the form of a manual kit, the new Validation Agent(TM) automatically runs 360 different scripts, for desktop or server based installations, and writes a 600 page validation summary document in Microsoft Word. Additional information included with this kit are InnaPhase corporate information, software development methodology used, electronic test and reference data files, full testing protocol and templates, and installation checklist templates.

"The Validation Agent can be run as many times as required and provides automated, fast and reliable installation testing for any Kinetica 2000 configuration", said Richard Wagner, Director of Enterprise Sales for InnaPhase Corporation. "The entire installation validation process is therefore reduced, not to days or even hours, but to minutes. At any time during the installation and use of Kinetica 2000, internal and external auditors can repeat the entire validation process by the simple click of a button."

InnaPhase have focused deeply on the quality assurance side of PK/PD data management, analysis and reporting over the last year to release a further QA toolset as part of their new enterprise PK/PD system, EP1. This integrated QA toolset includes the Validation Agent, Data Trace and Audit Agent modules.

Data Trace offers internal and external auditors the ability to create automatic and comprehensive quality assurance reports that address all aspects of data trace-ability. The Study Reconciliation Report contains a list of transformations found in all data, both input and computed, between the start and end of a study's history. The Computational Content Report contains a list of all computational methods and the local options chosen to analyze a study. Finally, the Quality Assurance Report lists the full traceability history of the study since its introduction into the EP1(TM) System. With the addition of the Audit Agent, EP1 provides full GLP compliant security and auditing without reducing productivity. Data modifications are tracked within the EP1 system with full electronic signatures and user justification comments as per the Food and Drug Administrations 21 CFR Part 11 guidance. The Audit Agent allows companies to easily search and report the audit trail across multiple projects and studies.

"Our Quality Assurance tools provide our clients with the means to significantly accelerate their data review time and enable compliance with regulatory guidelines, while still allowing scientists the flexibility, speed and power they have come to expect from InnaPhase products," Wagner said.

About InnaPhase Corporation

InnaPhase Corporation (http://www.innaphase.com) provides innovative technology solutions for early drug development teams. With more than 800 client organizations in 45 countries, the company's software technologies allow clients to maximize their drug development pipeline. InnaPhase leverages scientific experience with advanced software and database technologies to provide specialized systems that are powerful, yet easy to use, and highly scalable. In the race to reduce the time and cost for drug development, InnaPhase's fully integrated and scalable set of database technologies provides a competitive edge. With offices in the United States, France and England, InnaPhase is rapidly becoming the industry standard in software applications for pre-clinical and clinical pharmacology.

The InnaPhase name and design is a registered trademark. EP1, Kinetica 2000 and Validation Agent are trademarks of InnaPhase Corporation. All other company names and products are trademarks or registered trademarks of their respective companies.