DISTEK Dissolution and Pharmaceutical Test Instruments
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Cipher Dissolution Control Software
Cipher dissolution control software developed by Distek is a windows based application designed to be provide either local or network to any Distek dissolution instruments on the network. With various and fully customizable levels of security, the software allows the user to bring the instruments within compliance to the match your developed policies. All of which are designed to meet 21 CFR part 11 compliance.
Fully Customizable Access Levels
Allows for a wide range of access levels from system administrator, to customized access roles such as analyst where only methods can be selected or for QC where document viewing and approval is allowed. All of which can be tailored to your local policies. Most of which can be setup through an easy to use tick box system.
Customized System Policies and Reporting
Allows for a range of auditing and customizable report authorization levels from full access to multiple layers of report authorization required before the analysis report can become fully authorized and the results released, with ASCII LIMS compatibility if required. All levels of authorization can be tracked and viewed on the finished analysis report.
Remote System Control
The network capability of Cipher allows for systems to be monitored anywhere on the network that the systems are linked. This allows for the performance of the instruments to be monitored in the safety of an office. The advanced tracking capability of Cipher allows for a wide range of integer time points to be monitored, ensuring that the system remains within USP guidelines throughout the experiment. However, once a Cipher method has started on the instrument. it is not possible to control the instrument locally until completed, except for emergency stop.
Method and Event Audit Trail
The method audit trail is an integral requirement of an electronic record, ensuring the validity and integrity of the record. Cipher records all changes to a method, when it was accessed and by whom. The same applies to the event audit trail. Allowing for auditing of the entire process, even for systems such as the 4300, 6100 and 6300 which did not originally come with such features built in.
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)
Cable, USB 2.0 for Cipher and Printer, 16 Feet
IQ/OQ Installation and Operational Qualification including Documentation for Distek Cipher Dissolution Software.
Additional Seat for Cipher Software. Requires Host ID of Security Server
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.