Purpose

Set of procedures that prove that expected results can be consistently reproduced in system(s), equipment, process(es), method(s), or instruments.

Capabilities

Creation Process

Preliminary Assessment of necessary documents

Diagrams / Layouts

Drawings

Schematics
Manuals Procurement

Design

Writing / procuring

Approval process

Execution Process

Execution of validation protocol and test cases

Deviation and Corrective Action Process

Re-execution of deviated sections

Report Process

Raw data assessments

Review of executed code(s), protocol(s), and test cases.

Approval Process