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Distek, Inc.
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Distek Cipher - Dissolution Control ...

Distek Cipher - Dissolution Control Software for 21 CFR Part 11 Compliance

The Cipher Dissolution Control Software, developed by Distek, is a versatile Windows-based application that, when paired with properly developed customer policies, ensures full compliance with Data Integrity and 21 CFR Part 11 regulations. Cipher can be installed either as a self-contained local installation or on a network. It controls Distek dissolution testers, dissolution autosamplers, and tablet disintegration testers. Designed with flexibility in mind, Cipher Software allows users to customize security settings to meet both regulatory requirements and specific company policies.

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21 CFR PART 11 / DATA INTEGRITY

Complete 21 CFR Part 11 and Data Integrity compliance for Distek dissolution, autosamplers, and disintegration instruments.

eSIGNATURES

Electronic signatures can be applied to both methods and reports. Signatory levels can be set to originator, approver, or reviewer, with customizable permissions.

METHOD WIZARD

Guides the user through method creation and optimization for dissolution, autosampler, or disintegration measurements.

LIMS COMPATIBLE

Provides simple automatic export of result files in an ASCII format for access and use by any user LIMS package.

INSTRUMENT NETWORKING

Users can log on to a client workstation and view the current status of any compatible Distek instrument on the network, allowing real-time, remote instrument setup and monitoring.

AUDIT TRAIL

Tracks event, system, and method changes with a computer generated date and time stamp. Additional information logged includes the user, old and new values, and the reason for the change. The report is in a human-readable format.

COMPENDIA ALERTS

Allows the user to set specific tolerances for critical operating parameters. The system alerts the user if a reading falls outside the acceptable range.