Common Mistakes in Computer System Validation
Modern scientific laboratories increasingly rely on computerized informatics systems (e.g., LIMS, ELN, CDS, etc.) to process and manage data. To ensure product safety and effectiveness, it is important for these systems to be validated in a process known as computer system validation (CSV) to confirm the accuracy and integrity of processed data.Regulatory agencies like the FDA, in fact, require CSV to verify and document that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. CSV is required by the FDA when implementing a new system or when making a change to an existing system (upgrades, patches, extensions, etc.) that has been previously validated.
[Read More]
