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Security threats Toolkit

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Planning and Remediation of Systems for Part 11 Compliance

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9 out of 20 users found this white paper useful


Publisher Prime Technologies
Publisher Registration Direct Access
Topics Security Management Date added 01 Sep 2006
Downloads 9 Format HTML

In order to perform remediation planning, it is best to have a plan that details what is to be done, who is to do it and the time frames necessary to affect a speedy resolution. Create a project plan in both narrative and chart format that contains work breakdown structures for collecting information about each application, computer or computerized system. This information becomes part of the Validation Master Plan describing the details of the information collected. The outcome of the work from the Project Plan is a Validation Master Plan. From this, the various projects and their priorities are identified and created. Gap analysis or retrospective validation is performed. Procedural and System Controls are identified and put into place.

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