9 Tips To Comply with 21 CFR Part 11

For highly regulated medical device companies and life science industries, it has become a challenge to achieve 21 CFR Part 11 compliance and a matter […]

The 3 Q’s in Computer System Validation

When it comes to the FDA regulated businesses, the industries always follow the Computer System Validation approach. Managing the computer system validation process is often […]

FDA Transition to Computer System Assurance: The New CSV

The FDA 2003 guidance has paved the road for implementation of efficient computer system validation for the pharmaceutical industry. Following the FDA guidelines, the life […]

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