SmartShell Software

SmartShell 2.1 software provides 21 CFR Part 11 remediation for PC-based instruments and desktops applications that do not comply with the Part 11 regulations. It also provides centralized security and access control administration for all laboratory instruments, and a centralized secure repository for all regulated data. In addition to PC-based instruments, the software also provides these same capabilities for Microsoft’s Excel, and Word applications. The “Shadow Mode” of operation allows remediated applications to write directly to the local disk from where a copy is immediately transferred to the secure Records Management System. If a file is modified, a new version is automatically created in the Records Management System and the analyst must add his or her electronic signature and a reason code. This technology ensures a fail safe result if the network connection is disabled for any reason, as the data is automatically retransmitted as soon as the network is restored.