VALIDATION DOCUMENTATION MATRIX

Validation Documentation Matrix Introduction

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 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.

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The use of the Matrix.

All production process equipment must be listed in an multi-column matrix.  Column 1, of this matrix designates the priority that the equipment is to receive in this validation task.  Number one will be the first equipment qualified, and then the validation of the listed equipment will follow in chronologically order.  Column 2, 3 and 4 are used to identify the item and its location.  Columns 5 indicates whether the system generates data that is the subject of a predicate rules requirement.    Column 6 will be generated from the execution of the risk assessment against the equipment.  Column 7, 8, 9, 10 and 11 are used to assess progress.

This correct execution of this procedure will define whether the equipment under assessment must be validated, what the scope of the validation should be and whether the "equipment produces data" that is classified as predicate data.  It therefore enables column 5 and 6 of the matrix to be completed, thus defining the scope and depth of validation that this piece of equipment demands.        

• Sheet 1 - Utilities & Facilities Validation Matrix.
  
  
• Sheet 2 - Process Equipment Validation Matrix.
  
  
• Sheet 3 - Laboratory Equipment Validation Matrix.
  

Validation Packages an introduction.

During a regulatory visit the inspectors do expect to see a complete suite of validation documents in place for each validation task.  The use and scope of the individual documents has been documented, discussed and explained in detail.  It is therefore obviously best policy to have in place exactly what the regulator is looking for.  The use of a document packages ensures a multitude of regulatory requirements are catered for and possibly a similar multitude of pitfalls, blunders and omissions are anticipated and negated

VALIDATION DOCUMENTATION MATRIX