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Issue:

Book Reports

 

Written by:

Wanda C

 

Date added:

October 27, 2015

 

Level:

University

 

Grade:

A

 

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5 / 1336

 

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With approximately 130 employees, they produce products that are made into Serum Albumin and IV products. The company's focus is Biologics and Contract Manufacturing serving multiple applications. {KISTLER-MORSE}           Problem The plant was expanding and the company wanted to look at new technologies...
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Due to the FDA's data collection requirements for 21 CFR Part 11, they wanted a way to check the data that the batch control system is acquiring to verify the system's accuracy. The data was currently being collected by a PLC and captured in an SQL Server. They also wanted to calibrate the vessels from the clean room, but the multi-vessel controller for the weight system was located in an unclassified area making this impossible for one person to accomplish...
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