Compliance with 21 CFR Part 11 – Strategies and Practices

Compliance with  US FDA’s 21 CFR Part 11 Regulations is very critical for medical device and pharmaceutical companies. However, there are some grey areas that companies often face when they try to comply with  21 CFR Part 11. There is a common opinion or perception that we have seen where many companies think they are complying (often due to misunderstanding the requirements), but in reality, they are not. [Read More]

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