A quick guide to help cleanliness testing meet the requirements of Part 11 of Title 21 of the Code of Federal Regulations
The US “Chapter 21 of the Code of Federal Regulations” Section 11 defines the standards for electronic data integrity established by the US Food and Drug Administration (FDA). Industries regulated by the U.S. Food and Drug Administration (FDA), such as medical device manufacturers and pharmaceutical companies, must comply with the provisions of Section 11 of 21 CFR to ensure the accuracy of electronic records and … Continue reading A quick guide to help cleanliness testing meet the requirements of Part 11 of Title 21 of the Code of Federal Regulations