DISTEK Dissolution and Pharmaceutical Test Instruments
DISTEK > Software > Cipher
Cipher Dissolution Control Software
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.
FEATURES
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.
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LIMS COMPATIBLE
Provides simple automatic export of result files in an ASCII format for access and use by any user LIMS package.
21 CFR PART 11 / DATA INTEGRITY
Complete 21 CFR Part 11 and Data Integrity compliance for Distek dissolution, autosamplers, and disintegration instruments.
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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.
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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.
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.
GALLERY
Ordering Information, Accessories and Parts
Part Number | Description |
|---|---|
ORL-CIPHER-IQOQ | IQ/OQ Installation and Operational Qualification including Documentation for Distek Cipher Dissolution Software. |
ORL-6690-0151 | Cable, USB 2.0 for Cipher and Printer, 16 Feet |
ORL-6690-0001 | 4 Port USB to Serial Hub for use with Cipher Software. Includes One USB Cable. Must Order up to 4 RS-232 Cables p/n 4952-0013 and or 4952-0015 (7100 and 2500 Only) |
ORL-CIPHER-LIC | Additional Seat for Cipher Software. Requires Host ID of Security Server |
ORL-CIPHER-SFT | Cipher, 21CFR Part 11 Instrument Control Software for Distek Model 2100C, 6x00, 5100, 7100, 2500 Series, 4300 & 5300.
Full 21CFR Part 11 Compliance Requires Customer Participation. Software Provides Total Instrument Control and Monitoring Including Remote Access.
Software Includes One License. |