In the pharmaceutical industry, computerized systems (hardware, software, processes) play a critical role in creating and managing data, producing products, and ensuring compliance with regulatory requirements. 21 CFR Parts 210 and 211 contain aspects which drive the need for computer system validation (CSV). Of course, there is 21 CFR Part 11 (electronic records and signatures) […]
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Computerized systems (hardware, software, and processes) play a critical role in the medical device industry. They are used to create and manage data, produce products, and ensure compliance with regulatory requirements. Computer system validation (CSV) is the process of ensuring that computerized systems meet their intended requirements and can consistently produce accurate and reliable results. […]
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Pharmaceutical manufacturing is a highly regulated industry that requires strict adherence to quality and regulatory requirements. However, staffing shortages or a backlog of projects can put companies at risk of non-compliance and costly delays. In such cases, staff augmentation services can provide an effective solution for pharmaceutical manufacturers to meet their CSV needs. In this […]
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In Food and Drug Administration (FDA) regulated industries, computer systems and software play a critical role in managing data, controlling processes, and ensuring compliance with regulatory requirements. To ensure the safety, efficiency, and quality of pharmaceutical products, the FDA has established specific regulations and guidance documents that outline the requirements for computer system validation (CSV) […]
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