WinSort II Statistical Analysis Software for the Older "P-Series" SADE Sorters

WinSort Statistical Analysis Software

 

General Description:

With a strong emphasis on data security, WinSort II provides pharmaceutical manufacturers with the older model P2 and P4 weight sorters a secure means to store and analyze data from batches sorted on a SADE. All operator actions are recorded in logs and the program can be configured to require an electronic signature as confirmation. For further security, WinSort II can also be configured to prompt a second user to confirm approval. A batch report may be printed, showing batch details, operator name, sort statistics, calibration history, approvals, and with sort data presented as a histogram.

WinSort II is highly configurable, incorporating multi level security. WinSort II integrates with the Microsoft® Windows Security on the PC at local or Network level to limit access to authorised users only. Named users are allocated specific roles within Winsort ll. Roles such as supervisor, operator or administrator can be configured to limit access to specified actions. An auto log-off timeout can be set to increase security. Once a sort process has been started, the sort data is stored on a secure database located locally or on a network server.

These features make the WinSort II software compliant with the requirements as detailed under section 21 CFR Part 11 regulations regarding electronic records and signatures.

WinSort II can capture sort data from up to 4 SADE sorters simultaneously. It is also possible to view and print data from one sort, while running a separate one. There is context sensitive on-line help, and the system is user-friendly. WinSort II is available for retrofit to existing the older SADE units and is supplied with a comprehensive optional validation documentation pack, helping customers to save time and money on validation.

WinSort II is not for the new "SP Series" of SADE sorters since many WinSort II features are now included with the SP Series control system.