VALIDATION DOCUMENTATION MATRIX
The Validation Documentation Matrix, gives a very concise overall picture of your validation program. This four part matrix allows you to list all the equipment and systems that must be qualified. Each entry is allocated a row in the matrix. The row consists of eleven headings as shown below, these may be edited as required. In this matrix there is room to enter the document number, prefixed by, A to D. The document number gives you the instant cross reference to the current document and the A to D prefix, indicates the progress stage. The basic philosophy underlying the use of a matrix for data verification and validation is to establish clear expectations and requirements that have been ground-tested for practicality and reasonableness this enables the organizations to succeed rather than fail for lack of direction. An allied concern is that data verification and validation will be viewed as an integral part of validation. The incremental approach affords time for exercising leadership, changing organizational culture, refining processes, and establishing clear accountability. It avoids imposing a large front-end reporting burden that could meet with resistance and might end up significantly impacting other priorities.
VALIDATION DOCUMENTATION MATRIX
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