Source: http://www.google.com/patents/USRE43527?dq=U.S.+Patent+%23+5,723,324
Timestamp: 2014-03-17 12:27:49
Document Index: 228543342

Matched Legal Cases: ['Art 25', 'Art. 26', 'Art. 26', 'art 11', 'art 11', 'art 11', 'art 4']

Patent USRE43527 - Methods, systems, and software program for validation and monitoring of ... - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsMethods, systems, and software program for validation of pharmaceutical manufacturing processes and quality assurance process are described and disclosed herein. Consequently, the methods provide a means to perform validation on an integrated level whereby the quality control unit can ensure data and...http://www.google.com/patents/USRE43527?utm_source=gb-gplus-sharePatent USRE43527 - Methods, systems, and software program for validation and monitoring of pharmaceutical manufacturing processesAdvanced Patent SearchPublication numberUSRE43527 E1Publication typeGrantApplication numberUS 12/313,804Publication dateJul 17, 2012Filing dateNov 25, 2008Priority dateMay 6, 2004Also published asUS7392107, US7428442, US7444197, US7471991, US7509185, US20050251278, US20060271227, US20060276923, US20070198116, US20070288114, US20090143892, US20100324716, US20110046770Publication number12313804, 313804, US RE43527 E1, US RE43527E1, US-E1-RE43527, USRE43527 E1, USRE43527E1InventorsShane M. PoppOriginal AssigneeSmp Logic Systems LlcExport CitationBiBTeX, EndNote, RefManPatent Citations (103), Non-Patent Citations (71), Classifications (11) External Links: USPTO, USPTO Assignment, EspacenetMethods, systems, and software program for validation and monitoring of pharmaceutical manufacturing processesUS RE43527 E1Abstract Methods, systems, and software program for validation of pharmaceutical manufacturing processes and quality assurance process are described and disclosed herein. Consequently, the methods provide a means to perform validation on an integrated level whereby the quality control unit can ensure data and product integrity and minimize cost.
1. A method for monitoring a pharmaceutical manufacturing process using at least a dry heat sterilizer, said method comprising:
a) deriving an algorithm implemented in computer executable instructions that performs data analysis on said pharmaceutical manufacturing process using at least a dry heat sterilizer;
c) performing �software safety code analysis� on said algorithm;
d) performing �software safety design analysis� on said algorithm;
e) performing �software safety requirements analysis� on said algorithm;
f) performing �software safety test analysis� on said algorithm;
2. The method of claim 1, wherein the �data analysis� is selected from the group consisting of �boundary value analysis�, �block check�, �branch analysis�, �control flow analysis�, �failure analysis�, and �path analysis�.
The computer product is integrated into the manufacturing system on a device-by-device basis. As previously set forth, the acceptance criteria of all devices used in the drug product manufacture for the purposes of the manufacturing process to are determined by the quality control unit. The analysis of the software and hardware occurs using any of the methods disclosed herein. (See for example FIG. 1 and FIG. 3). The program monitors and processes the data and stores the data using standard methods. The data is provided to an end user or a plurality of end users for assessing the quality of data generated by the device. Furthermore, the data is stored for comparative analysis to previous batches to provide a risk-based assessment in case of failure. Using the historical analysis will provide a more streamlined manufacturing approach and will provide cost-saving over time. In addition, the invention comprises monitoring the data from initial process, monitoring the data at the end process, and monitoring the data from a routine maintenance schedule to ensure the system maintain data integrity and validation standard predetermined by the quality control unit.
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Tech., May 2004, pp. 1-8.71Whitepaper, Emerson Process Management Manufacturing Execution Systems Capabilities, Mar. 2007, pp. 1-27.* Cited by examinerClassifications U.S. Classification700/110, 700/207, 700/109International ClassificationG06F19/00, G06Q10/00Cooperative ClassificationG05B23/0224, G06Q10/06, G05B2219/1112, G05B2219/11European ClassificationG06Q10/06, G05B23/02S4HRotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services©2012 Google