With the Protocol Manager software, the methods used in the dissolution tests, the generated reports, event and error lists can be collected and stored in an advanced way.
The dissolution testers, samplers and filter changers belonging to the Hanson Vision G2 family collect, use and store a significant amount of information during their operation: 50 users and 100 methods can be created, the instruments retain the results of the last 8 tests and store the last 331 errors and the records of 543 events. The easiest way to manage, sign, and long-term preserve the resulting data is to print them, thus, the printed results can be signed and archived. The instruments provide the possibility of saving the data on a USB flash drive and collecting them on a computer. The methods and users saved on the USB flash drive can be transferred to another Vision G2 instrument as well, ensuring that the tests are performed based on the same protocols.
With the Protocol Manager software the management of dissolution test results and events can be taken to the next level to meet the data integrity requirements in every way. The software is suitable for handling the Teledyne Hanson Vision G2 Elite8 and Classic6 dissolution baths, the Dissoscan and Maximizer samplers, and the AutoFilter filter changer. From the listed modules, an unlimited number of instruments can be registered in a software and data can be collected from them. The Protocol Manager is compatible with Windows 10 and uses an SQL database to store data. The server-client design and the data traffic through the TCP/IP (“Internet”) protocol allow flexible installation solutions. As the simplest solution, a computer located near the dissolution tester can be used both as a server and a client. In the case of several dissolution testers, as a complex solution it is possible to store the data on a central server and install the client module on one or more computers in the laboratory or offices using the company’s internal Internet network. By permitting the remote access, the results can be approved and signed even from home.
The Protocol Manager has an easy-to-understand interface that provides simple drag-and-drop data movement. The software includes all the security features that allow the user to provide the 21 CFR Part 11 data security compliance. All the data – except the user information – are transferred to the Protocol Manager from the registered dissolution test modules. The protocols in the database can be modified or copied without any modification into the memory of another instrument. There is a familiar structure for writing and modifying the protocols on dissolution tester modules, thus, users who have already written a method on a Hanson dissolution tester or sampler can use this feature immediately. Changes made to the protocols are recorded in the audit trail. The user with the help of the built-in function of the Protocol Manager can detect and correct any protocol errors (e.g. “time conflicts”) still on the computer. The completed protocols can be copied onto one or more instruments, and can be used as if they have been created on that instrument. It is not possible to log in into an instrument from the Protocol Manager, thus, tests cannot be started from the computer either. A test can still only be started from the instrument after the user – standing in front of the instrument – is confident that everything is available to perform the test.
The events, possible errors and also the completed reports of the dissolution tests are automatically recorded in the database. The reports are stored in pdf format and can be signed electronically. The data can be sorted, filtered and searched in several ways. Because the amount of data that can be stored is limited only by the size of the SQL database (10 GB in the case of free SQL Express) or the storage capacity of the computer, an infinite amount of information can be managed with the Protocol Manager for dissolution test data collection.