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
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