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April 15, 2003 | Companies with low budgets and lots of computer systems that aren't compliant with 21 CFR Part 11 must prioritize which ones to fix first. One way is to estimate the data-security risk for each system and the cost of Part 11 validation, then plot that system on a matrix like the one below. Systems and processes falling in the risk range of 60 percent or higher should get high priority.  
A Central database for inventory management  92% 
B Lab spreadsheets and databasesfor data collection  80%
C Systems for quality processes and standard operating procedures  79%
D Systems for manufacturing processes  75%
E Systems for liquids processes  73%
F Systems for company financials  63%
G Systems for other R&D data  58%
H Systems for customer relationship management  46%
I Systems for packaging  25%
J Systems being decommissioned  22%

Source: Clarkston Consulting

Back to Easing the Pain of Part 11 








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