Valentia Analytical – Analytical Lab Born in GMP

Scientific Data Management System Implemented

The major analytical systems that Valentia Analytical utilizes include Ultra-High/High Performance Liquid Chromatography, Capillary Electrophoresis, Variable Pathlength Spectrometry, Gas Chromatography, and Mass Spectrometry.   These systems are coupled with computerized data systems for data acquisition, data processing and data storage.   While they are different in technologies, all technologies share the common requirement for compliance with 21CFR11, data security, and data back-up/archival.  A Scientific Data Management System (SDMS) was implemented to provide a centralized, secure process to fulfill this requirement.  The SDMS was implemented at Valentia Analytical to reach into all analytical computerized data systems, across all vendors, to capture all data files generated from the system.  This system captures all data file versions.  Centralization of the system places all data into a common data file format, which will serve as the precursor for implementation of coming of the Electronic Laboratory Notebook (soon).  The system is configured fully compliant with 21CFR11, enabling security and audit trail review.  Furthermore, because all data are captured into the same database, the data back-up process is simplified.   All data are backed-up/archived onto a separate server.   The data from all computerized systems now have the following attributes:   1.  Presentation into Common Data Format, 2.  Centralized Database, 3.  Centralized Secuity, 4. Centralized Back-up, 5. Centralized Archiving.