Chapter 1. Validation Responsibilities



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

Corporate Responsibilities



This topic looks at Development and Execution (D&E) Personal and Business Unit validation responsibilities.


D&E Personnel responsibilities

·         Computer System Validation and Computer System Validation Policy

The (CSV) Computer System Validation and Computer System Validation Guide (this document), provides guidance on how to achieve conformance to the above policy.


Business Unit responsibilities

Each business unit is responsible for establishing a policy on computer systems validation requirements.


Business Unit policy

The Business Unit policy may apply to an entire Business Unit, or to some other logical business grouping, for example, site or department.

The Business Unit policy should be based on and comply with the (CSV) Corporate policy as a minimum requirement.

The policy should also take into account additional Business Unit specific validation requirements. These additional requirements may result from other policies within a Business Unit or a regulatory requirement.

Note: If a Business Unit policy requires higher standards than the (CSV) Corporate policy, then the Business Unit policy should be followed.



Site or Departmental Responsibilities



This topic looks at site or departmental validation responsibilities.



Sites or departments are responsible for:

·         Computer system validation Standard Operating Procedures (SOPs)

·         System inventory and assessment

·         System specific validation protocols

·         System specific validation documentation


Standard Operating Procedures (SOPs)

SOPs provide specific procedures for validating computer systems at a site or within a department.

SOPs must:

·         Comply with the Computer Systems Validation Policy and any Business Unit policies that may apply

·         be approved by the appropriate management for that site or department

System inventory and assessment

Site or departmental management is responsible for compiling and maintaining details about their computer systems. This information includes identifying the systems that are being used and for what purposes those systems are being used.

The system inventory and assessment information is used to determine which systems need to be validated.

See Chapter 2 - Before You Perform System Validation for details on how to perform the system inventory and assessment.

Note: The systems that require validation will be incorporated into the Site or Departmental Validation Master Plan.

After the initial site/departmental inventory has been complied a mechanism must be established to capture new computer systems (preferably prior to purchase / development) and to add them with the inventory and Validation Master Plan.

System specific validation protocols

Validation protocols are documents associated with each system identified as requiring validation.  The protocol describes the scope, procedure to be followed, responsibilities and acceptance criteria for the validation.

Validation protocols should comply with the SOPs.

System specific validation documentation

Documentation that verifies each validation activity must be generated and stored with the validation protocol in the appropriate archive.

Validation documentation may include:

·         test data

·         summary reports

·         procedures

·         certification forms produced during the validation process



Introduction to CSV Validation Responsibilities Before You Start Validation The Process Establish Teams(s) Determine Activities
Write the Protocol System Development Details Perform Qualification Activities Develop &  Review  Procedures Certify the System Review Periodically