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Original research LIFECYCLE MANAGEMENT OF STABILITY CHAMBER WITH COMPUTERIZED SYSTEM USED IN PHARMACEUTICAL INDUSTRYPages 292-304
Abstract
For the pharmaceutical industry to ensure product quality, operational efficacy, and regulatory compliance, effective lifecycle management of computerized systems. The following crucial phases are included in a systematic lifecycle approach: decommissioning, operation, maintenance, validation, and planning. Validation processes confirm that the system is reliable and that it complies with Good Automated Manufacturing Practices (GAMP) and legal standards. Risk-based methods are employed to identify and resolve any problems that can compromise a product's efficacy or safety. Examples of cutting-edge technology that enhance data integrity, speed up procedures, and lower regulatory hurdles include automation and digital workflows. The pharmaceutical business depends significantly on the lifecycle management of computerized systems to guarantee data integrity, operational effectiveness, and regulatory compliance across crucial processes like engineering, testing, production, warehousing, and planning. Lifecycle management is further improved by modern tools like automation, artificial intelligence, and machine learning, which accelerate regulatory submissions, simplify processes, and improve decision-making.
Keywords:
Computerized system, GAMP, Risk- based method, Lifecycle management, Regulatory submission.
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Sonia K., 
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