The Cipher dissolution control software is a Windows-based application designed and developed by Distek which can be installed locally or networked providing full access to any Distek dissolution instrument on the network. Cipher offers the flexibility to set the level of security appropriate for your laboratory. When enabling all available security features and audit trails and combined with the appropriate customer-developed policies, Cipher will meet 21 CFR part 11 compliance. Easy to use and intuitive, the Cipher software features make preparing, running, monitoring, and reporting dissolution test results quick and easy.
21 CFR PART 11 COMPLIANCE
Combined with the appropriate customer policies, Cipher balances the requirements of compliance with limited intrusion into user activities.
The user is walked through the method setup for a dissolution instrument and autosampler.
When configuring the system, two clicks of the mouse permit the automatic exporting of result files in an ASCII format for access and use by a LIMS package.
The use of electronic signatures guarantees that only approved methods can be used, and reports released.
Users are able to log on to a client workstation and view the current status of any Distek system on the network. Permits real-time, remote instrument setup and monitoring.
Event, system, and method changes are tracked 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 user can set the specific tolerance parameters for rpm and temperature requiring the system to alert the user should a reading fall outside the acceptable range.