Q-Diss: The Validation Software for all Dissolution Testers
Q-diss is a new software package for ensuring correct and consistent validation for all brands of dissolution tester including VanKel, Distek, Hanson Research, Erweka, Pharmatest, Sotax and Electrolab.
Q-Diss guides the operator through a standard procedure, defined by you. A step-by-step process ensures that all of the key parameters of the dissolution tester are measured correctly, recorded correctly, and are fully traceable.
Once complete, the test criteria, procedures, observations, results and tooling used are combined to form an electronic logbook for each individual tester. This then forms a traceable history which fully conforms to inspection requirements.
Key features
- Compliant with USP or ASTM requirements
- Guides the user through complete validation
- Simple to select the individual tests that you require for your laboratory
- Produces complete electronic logbook including calibration certificates
- Ensures consistency between any dissolution testers
How does Q-Diss work?
Preparation
Q-Diss contains a library of all visual and mechanical procedures that conform to all aspects of the USP or ASTM guidelines for validation.
The Q-Diss 'Administrator' creates a protocol for a specific dissolution tester from the test library. For example, if only paddle tests are run on one dissolution tester then no basket tests are included.
Once complete, the validation protocol is locked, linked with a specific dissolution tester (via serial number and description), and available for the Q-Diss 'Users' to run. Security access ensures that 'Users' do not have administrative rights and therefore cannot modify a defined protocol.
Operation
The Q-Diss screens guide the user step-by-step through the procedures, providing instruction as required. Essential information must be entered to ensure the protocol is completed correctly. All tools used are also recorded along with their traceability.
As each procedure is performed, it either passes or fails and is entered into the data 'bank' that is used to create the final logbook. A certificate also becomes available for that individual procedure.
Once all the procedures are complete, the logbook may be viewed, stored as a PDF, or printed as required. A successful validation protocol will result in a comprehensive and fully compliant document that will satisfy even the most demanding inspection.
The Q-Diss guarantee
It is simply impossible to cut corners, perform tests incorrectly or make mistakes with Q-Diss. Once the validation protocol is defined, any authorised user can perform the same set of procedures at a later date for a specific dissolution tester.
What do I need?
Q-Diss-S is the basic validation software. It contains everything that you need to complete two dissolution tester validations (i.e.1 year). It includes all SOP's, the software and procedures for the USP and ASTM.
Q-Diss-L contains a license to run two more validations for a single dissolution tester. Multiple licenses (for multiple dissolution testers) can be applied to the same basic Q-Diss software meaning only one basic software package is required per laboratory or department.
