Computer System Validation
CSV is a systematic process that involves a number of critical and important activities during the product life cycle, verifying that the final product quality complies according to regulatory requirements and will produce information or data that meets defined requirements.
Pharmaceutical industries need to validate the systems that are in the manufacture of pharmaceutical impurities, active pharmaceutical ingredients APIs, and drug products including biotechnology and biological products. CSV is a distinctive process that maximizes effectiveness and enhances quality. Evidently, the computer systems which are involved in the manufacturing of pharmaceutical products should meet the standards as per the industry norms.
Computer system validation in the Pharmaceutical Industry
In the pharmaceutical industry, any computers involved in the following processes should be validated; research & development, laboratory lab notebook manual, batch record manufacturing process, analytical testing, stability process, and raw material storage & packaging.
The validation of computers helps to handle any unanticipated challenges and complications during processes, avoid loss of data, continuous improvement and updates increase the efficiency of the systems so that the quality is built in the entire system at all the steps. Overall the complete process is controlled in a defined manner so that the final results of the production will not differ over time.
The requirements for computer system validation
Computer system validation requires the validation plan, training, and documentation including standard operating procedure (SOP). FDA guidance as described in FDA 21 CFR 11; the requirement of validation of computer systems, specific controls, rule requirements, impact on reliability, availability, authenticity, and records.
As per the FDA guidance the quality system regulations require that “when computers or automated data processing systems are used as part of the quality system or production, the (device) manufacturer shall validate computer software or its intended use according to protocol”. Good manufacturing practice for Active Pharmaceutical Ingredients (Q7), as per the guidelines the computer system should be validated, and also it depends on the complexity, diversity, and criticality of the computerized system.
