SDMS
SDMS provides a Web-based platform that integrates with multiple analytical and software systems for a compliant, enterprise-wide data management solution. It addresses legacy concerns by bringing existing systems into compliance. Compliance to all aspects of 21 CFR Part 11 can be addressed with traceability, electronic signatures, and a security grid for privilege purposes. It also provides the ability to search through the database catalog using either browsing techniques or using direct ad-hoc queries, and gives scientists direct access to their archived data such that it can be located and restored quickly. The quicker documents can be assembled and presented to an FDA inspector, the less likely those organizations will come under further scrutiny.Booth #1244