In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component

FDA’s authority for CGMP comes from FD&C Act section 501(a)(2)(B), which states that a drug shall be deemed adulterated if “the methods used in, or the facilities or controls used for, its ...

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the...

2021年6月2日 · True Copy in GMP Regulations. A frequently used term in GMP is "true copy". EU GMP does not apply this term. The term originates from the US FDA and is first used in 21 CFR Part 211:

FDA responses to the questions regarding the process of certifying copies in clinical investigations. From Florence’s Complete Library of FDA eRegulatory and eSource Guidance

FDA uses the term backup in § 211.68(b) to refer to a true copy of the original data that is maintained securely throughout the records retention period (§ 211.180). The backup file should contain the data (which includes associated metadata) and should be in the original format or in a format compatible with the original format.

2023年3月23日 · The WHO guidance has detailed guidance on the retention of “true copies” under a section for “special risk management considerations for review of original records”, and clearly states that “2nd person verifier or technical verification process is required to compare the electronic copy to original” and that this 2nd person ...

2025年2月28日 · The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care...

2025年2月14日 · You can search the list by entering the DUNS NUMBER, BUSINESS NAME, or TICKER SYMBOL in the search criteria. Use the business name as your primary search criteria. You may separately search the...

The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor...