Companies operating in regulated industries such as pharmaceuticals, medical devices, and food and beverage must comply with strict regulations to ensure product quality, patient safety, and data integrity. In the United States, the FDA introduced 21 CFR Part 11 to govern electronic records and electronic signatures, while the European Union established Annex 11 under EudraLex to regulate computerized systems used in pharmaceutical manufacturing for human and veterinary products. These regulations define requirements for data security, traceability, and system validation. This paper explains the key provisions of 21 CFR Part 11 and Annex 11 and describes how LabVantage software helps organizations meet compliance requirements while maintaining efficient, secure laboratory operations.

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