Computer system validation must be supported at
different levels within the organization through policies, standards and
documentation.
This chapter describes the responsibilities for
validation at the following levels:
·
Validation, Qualification, and
Protocol Development and Executing (D&E) Personnel
·
Business Sector / Unit
·
Site or departmental personnel
(End Users)
·
Quality Assurance and
Regulatory Units
·
Corporate Management
·
Information Management, IT or
IS departments |