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Many find 21 CFR Part 11 the FDA’s requirements for data safety and integrity, intimidating. This regulation provides the criteria under which electronic records and electronic signatures are considered trustworthy and reliable. Electronic records aren’t just limited to documents – they can ...

What are the complexities, nuances, and considerations in establishing a compliant, effective, and practical quality management system for combination products? Integrating two types of quality systems to comply with FDA combination product regulations can be overwhelming. Come and enhance your ...