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FDA Cleared vs. Approved

FDA assigns terminologies to a specific medical device. These terms include FDA cleared, and FDA approved. Companies need to understand these terminologies since using them wrong can lead to serious legal consequences for their business.          What is the difference between FDA Cleared vs. Approved?  FDA cleared    A medical device is considered FDA cleared if it …

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Document Retention Pharmaceutical Industry

Document retention is essential for quality assurance systems in the pharmaceutical industry. It helps to avoid errors in spoken communication. In addition, document retention helps to trace the performed activities. Companies should comply with regulatory requirements when it comes to document retention.    How long does a document retain?  Documents and records should be completed to …

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Data Integrity SOP In Pharmaceutical Industry

Data integrity is essential in the pharmaceutical industry to ensure products’ quality, efficacy, and safety. In today’s modern generation, pharmaceutical companies use computers and automated systems for generating data. With this, regulatory bodies require companies to comply with data integrity. Meanwhile, in this post, we will discuss data integrity SOP. What is SOP?    SOP stands …

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Consulting Firms Pharmaceutical Industry

Consulting firms in the pharmaceutical industry have a big role in offering new treatments, healthcare delivery optimization, and enhancing efficiency in various operational and healthcare technologies.  Consulting firms come with experts with a diverse range of specialization. They have extensive experience in optimization in the market. Additionally, consulting firms have knowledge of compliance and regulatory …

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Compliance Issues In Pharmaceutical Industry

Regulatory compliance is essential in the pharmaceutical, healthcare, and medical device industries. Companies should comply with the regulations of regulators, including the FDA. Thus, it is required to ensure the products’ quality.        Why is regulatory compliance important?  Regulatory compliance is important for pharmaceutical companies to reduce risks in manufacturing their products. It also helps to …

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Change Control Procedure In Pharma Industry

In the pharma industry, changes need to be reported through a change control system in quality control, production, stores, quality assurance, engineering, and R & D departments. Therefore, change control comes with an essential role in pharmaceuticals.         Change control defined  Change control is necessary for controlling changes made in the pharma industry. If change …

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cGMP Regulations Medical Devices

The cGMP or Current Good Manufacturing Practice by FDA are strictly enforced to ensure that the medical devices are effective and safe to use. cGMP regulations are essential to improve consumer confidence through offering systems that can provide proper monitoring and control of manufacturing procedures and facilities.        FDA provides CGMP regulations on products in different …

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