| 摘要 |
The present invention is a solution for problems associated with batching, analyzing and viewing data from computerized and process control systems used in the manufacture of pharmaceutical products. Utilizing the hardware and software networking standards already implemented by a corporate IS/IT group as a platform, the present invention automatically captures (via 3<SUP>rd </SUP>party software), processes, archives, reports on and distributes data for any computerized equipment at a facility. Data formats for all equipment regardless of manufacturer, plant location, or hardware/software platform used, are standardized. A single data repository is provide so that any authorized user connected to the company/facility network will have the ability to query this secure data and can generate any number of different reports. Once data is collected, it is batched or grouped according to user defined rules. A batch is given a distinct number, which will then be used to identify the data. Within seconds of batching, data is automatically analyzed using process macro code. This code can be simple or complex as needed to provide only the most important details about a batch. Such analyzation eliminates the manual processing of data, which is usually complex, time-consuming and prone to error. Via the Intranet or Internet, authorized users can view or trend data and access reports including adding electronic signatures. Additional process information such as standard operating procedures, and cycle descriptions may be uploaded and attached to a batch. Any action a user performs that creates, modifies or deletes data in the data repository will be audited.
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