Validation of Commercial Off-the-shelf Computer Systems

Product Provides:

• Overview of validation principles Responsibilities.
• Planning computer validation activities.
• Setting specifications Qualification of the vendor Installation and configuration.
• Testing prior to use (Operational qualification) Testing during use (Performance qualification)
• Change control Validation report
• Validation of existing systems

Purpose:

• Software and computer systems should be validated for compliance and business reasons.
• Validation helps to generate accurate, reliable and consistent analytical results.
• This SOP gives guidelines on how to validate computer systems.

Scope:

• Validation of computer systems that have an impact on product quality.
• Validation includes all life cycle phases from system planning to retirement.
• The focus is on validation of commercial off-the-shelf system planning to retirement.
• Exceptions to this procedure are possible but should be based on risk assessment and justified, documented and approved by operation�s management and QA.