Shimadzu Total Solution for PIC/S and FDA Compliance

Network System to Regulatory Compliance

Shimadzu Regulatory Compliance Network Supporting Database Management Software LabSolutions/CLASS-Agent Features

LabSolutions/CLASS-Agent complies with the requirements of the FDA 21 CFR Part 11 (Electronic Records, Electronic Signatures). CLASS-Agent provides secure data management and electronic signature operations for measurement results registered in a database acquired from a range of instruments, including HPLC, GC, GC-MS, LC-MS, UV, FTIR, and balances, as well as other manufacturers' products. The data is automatically saved in the database for subsequent easy searching. Additionally, the associated method and schedule information, date of measurement, operator's name, and analytical report image files (in PDF format) are stored together. Client/server capability allows centralized management of data from all instruments and simple data referencing from a client PC.

Effective User Management

LabSolutions’ user administration comprises the setting of rights groups and assignment of rights to users just as in Windows. It enables the easy setting of user access rights as well as rights groups matched to each user's required tasks. Functions such as these achieve effective user administration matched to laboratory operations from managerial tasks to data acquisition operations.

Firm Security

Features functions for setting an audit trail to ensure data reliability and formailing events occurring on the system. It includes various settings, such as setting the length, expiration date and complexity of passwords for user accounts, setting the lockout function to prevent illegal access, and registering settings for the deletion and alteration of registered users, to enable highly secure system operation. Settings for overwriting data files and other information and relating to items to output in reports also are supported.

Log Browser for Ascertaining System Operation Status

The Log Browser allows the user to easily ascertain system status from operation and administration to usage status and error status. Functions to search for log details, user names, instrument names, etc. also are provided in order to verify the necessary information.

Audit Trail for Achieving Change History Management

The change history of method files is managed by the audit trail. Application of the audit trail to all methods can also be set in the security policy settings. This prevents inconsistencies in compliance with regulations. A history of postrun analysis after data acquisition can also be managed by applying the audit trail to data files.

For Research Use Only. Not for use in diagnostic procedures.

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