From simple data monitoring requirements to batch and validated processes, its security, communications and powerful visualization tools make it more than just a recording device. The compact unit can be wall or panel mounted and provide data in varying format to suit different department needs.
As data is sampled and logged in the 5000B, historical files are created in the 16Mbyte of internal Flash memory. The instrument can be configured to automatically pass these files over the network to a server for longer term archiving. In case of problems with the main server a secondary, back-up server can also be specified.
The files are in a secure format to protect them from tampering. Review software is supplied with the 5000B for reading of these files at a later date, and can be configured to automatically pull files from the 5000B and store them in its database.
The Bridge (remote instrument visualization) package can be installed on as many remote stations as required - from PCs to PDAs. Up to 4 users can view a single instrument at any one time.
With the correct security permission users can view live data, access historical information, perform operations (such as starting a batch or adding a comment to the record) and change the configuration of the instrument. With the Master Comms option the user can also view, operate and configure other remote instruments throughout the plant.
Up to six, user-defined fields can be configured to add batch specific data to be logged with the process data. These free-format fields may include data such as batch number, job number, customer name, cycle number etc. Operator details will be logged with the rest of the batch data on start and/or stop of batch, providing complete traceability of operations.
These features are specifically designed to provide comprehensive data security and traceability in line with the requirements of 21 CFR Part 11. They include a securer audit trail, electronic signatures, password aging, failed login account disabling, unlimited unique user names and passwords, timed logouts and recorded logins.