Pharmaceutical Company

For a pharmaceutical company, RHO provided the project management and developers for a Web-based Compliance Information Management System for Manufacturing and Laboratory Process Deviations.

The web based system supported E-signature for occurrences and Investigations and provided users the capability to generate reports in data and graph format for different purposes. Security testing, regression testing and data integrity testing were completed. Documentation was prepared for Computer systems validation life cycle, in accordance with FDA regulations, particularly 21 CFR part 11, including Validation Master Plan, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols.



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