Computer System Validation

ACC provides a full range of computer system validation services to customers in regulated industries. These services can be provided regardless of whether the target system was implemented by ACC, although validation is typically simplified when the system is developed following good system life cycle practices such as ACC's GAMP-based methodology. Depending on the customer's requirements, ACC can take primary responsibility for system validation, provide support as needed, or provide recommendations and guidance with respect to system compliance, such as 21 CFR Part 11 issues.

ACC believes that a successful and efficient computer system validation effort begins with thorough knowledge of the system, the underlying technology, and accepted industry validation practices. ACC's experience with the systems, components, equipment, and processes used in the life science industries enable ACC to add value beyond a traditional validation services firm. In many cases, ACC is responsible for computer system validation in coordination with a third party firm responsible for overall validation efforts.

Successful CSV begins with a well-organized plan. The Master Plan should describe the overall validation methodology and purpose of each protocol. Plans to leverage other test documents, such as factory and site acceptance tests, should be fully described. Validation protocols need to completely and accurately verify that the system has been installed and functions in accordance with a set of pre-defined requirements.

Validation Consulting

• Validation Planning
• Configuration Management Systems and Procedures
• Development of validation procedures, document and protocol templates (often to equipment vendors and other system integrators)
• Part 11 Assessments, Recommendations, and Remediation

Validation Documentation

• Computer System Validation Master Plan
• Installation Qualification
• Operational Qualification
• Validation Summary Report

Protocol Execution

• Execution of IQ/OQ
• Documentation of Test Results
• Incident Remediation and Retesting
• Coordination with customer and third-party personnel

Retrospective Validation

• Development of System Life Cycle (SLC) documents on existing systems
• Development and Execution of IQ/OQ
• Periodic Validation Assessments