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FDA Regulations Timeline

While there are many concerns in the vape community about upcoming FDA regulations, they may not take effect as quickly as some may think. When the first regulations for the pharmaceutical industry were drafted in 70's, it took 20 years…

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Risk Management – Manufacturing Software Validation

Quality risk management is a systematic process for the assessment, control, communication, and review of risks. It is an iterative process used throughout the entire computerized system life cycle from concept to retirement. Risk Management is based on clear process…

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Manufacturing Software Validation – Security Scheme

In manufacturing software validation, a security scheme is used to establish a permission set for each user role. This prevents users from accessing screens or functions that are outside their responsibility or authority. Security is managed through roles, objects, actions…

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