Thermo launches Part 11 compliant checkweigher

Although the responsibility to comply with the requirements of 21CFR Part 11 lies with the drug companies rather than the equipment suppliers, the weighing and inspection division of Thermo Electron Corporation has launched a 21CFR Part 11 compliant version of one of its checkweighers to meet the requirements of its customers in the pharmaceutical sector. The Ramsey AC9 Rx is the first in the company's range of equipment to provide secure electronic records and audit trail data; a retrofit software package is also available to enable existing AC9s to be upgraded to meet the regulations.

The new development generates secure electronic records of the checkweigher's operation using an electronic signature that is unique to the user because of the combination of user ID and password, which together equate legally to a handwritten signature.

The unique user ID, which consists of between seven and 12 characters, is allocated by the system administrator, while the password (6-12 characters) is selected by the user and can be changed at any time if the user suspects it has become known by another party. The password remains valid for a period of between seven and 60 days, as set by the system administrator, at which point it must be renewed. If it expires, the user is permanently disconnected and must be readmitted by an administrator.

For further protection, there are three access levels: Administrator, which gives full access to the menus; Service, which is reserved for maintenance personnel and allows access to functions that stop the production line; and Operator, which does not allow access to functions that could be dangerous to the process. When no user is logged in, a 'protected' mode comes into force, which allows no changes to any variables.

Audit trail records can be created in response to a range of events, including alarms reset, statistics clearing, product change, copy product, dynamic, static and speed calibration, tare zeroing and enabling/disabling options. Each record consists of date and time, user ID, event description, variable description, and new and old value of the variable. They are stored in files on a hard drive and can be exported to disk.