eData-Management Software Satisfies FDA Requirements
FDA standards to ensure the data integrity and security of electronic records and signatures are fulfilled by a computer program for the life sciences industry from Taratec Development Corp. (Bridgewater, NJ). Built on the Oracle8I platform, the Taratec e-Compliance program meets the criteria of FDA Title 21 CFR, Part 11, for securely managing data from electronic sources. The suite integrates into most existing computer systems, and is noninvasive to data sources or applications. Supported systems include data collection applications for laboratory instruments, data-entry applications, electronic batch record systems, spreadsheets, and word-processing programs. All levels of information have a full audit trail and are stored in a secure central location accessible through a Web browser. The software has comprehensive security controls that protect against accidental modification and unauthorized access.