Serie GOT2000

Seguridad y características adicionales del sistema

Support FDA 21 CFR Part 11
Con respecto a la asistencia para FDA 21 Parte 11 del CFR

¿Tiene problemas?

How can I support FDA 21 CFR Part 11 easily?

¡GOT resolverá sus problemas!

GOT can be used to make your system meet the requirements of FDA 21 CFR Part 11.

*The users must construct an appropriate system for the compliance with the FDA 21 CFR Part 11. For the details, please refer to the Technical Bulletin No. GOT-A-0077-E (PDF).

Características de la función

GOT can be used to support FDA 21 CFR Part 11, the standards about electronic data recording of the traceability information, which is required in the food and pharmaceutical industries. Sample screens are available for helping you configure systems.

GOT functions related to FDA 21 CFR Part 11

• (1)Managing users who access the GOT
  Operator authentication and security level setting
• (2)Managing screen data
  User management, access control
• (3)Completeness of data
  Network drive, FTP client, FTP server
• (4)Security and viewing of data
  Operation log, alarm, logging, recipe
• (5)Audit trail
  Registro de operaciones
• (6)Validation of data and operations
  Verification (GT Designer3 function)
• (7)System development, operation, and management
  Security level setting

Access management per operator

The operator authentication function enables management of users who can login to GOT.
(See details of Operator authentication function)

*To prevent impersonations, user accounts should be managed thoroughly by the users.

Recording audit trails (histories for the follow-up survey later)

Audit trails can be recorded and operated by setting the operation log appropriately.
(See details of Operation log function)

<Information required to be recorded>

• Time stamp
• User name of the logged-in operator
• Description and details of the operation performed by the operator
  (logs before and after the data change)

Detalles de especificación y restricciones

●Range of supporting FDA 21 CFR Part 11

The range that GOT can support the regulation is limited. For the details, please refer to the Technical Bulletin No. GOT-A-0077-E (PDF).

●Cómo obtener pantallas de muestra

Sample screens are included in GT Works3. Comuníquese con su oficina de ventas local para obtener más información.
The sample screens are supported by the following GT Works3 versions: Versión 1.152J o posterior.

Industrias recomendadas

Tipos de GOT compatibles