Reducing the Cost of Computer Systems Validation Efforts Through Risk Assessment

Computerized systems have been widely adopted by the pharmaceutical industry and are frequently used for instrument control and data evaluation, documentation, transmission and archiving in laboratories. The FDA requires that all computer systems in regulated environments be validated in a documented process known as computer system validation (CSV). CSV serves to verify that a computerized system does exactly what it is designed to do in a consistent and reproducible manner.

For regulatory compliance purposes, CSV confirms the accuracy and integrity of data created, modified, archived, retrieved and transmitted by a computer system in order to ensure product safety and effectiveness. Computer system validation is required when configuring a new system or making a change in a validated system (upgrades, patches, extensions, etc.).

Depending on the complexity and functionality of computer systems, CSV can be a significant undertaking. Pharmaceutical companies have even been known to delay upgrading applications to avoid the validation effort required. In this blog, we will provide some tips on performing a risk-based CSV in order to dramatically lower the costs of validation efforts.

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