사용자:서진선

데이터 무결성

데이터 무결성(data integrity)은 데이터의 완전성과 일관성 및 정확성을 의미한다. 즉, 제조와 관련한 모든 데이터가 그 생성, 수정, 처리, 유지, 보관, 검색, 전송이라는 데이터의 라이프 사이클 전반에서 일단 생성되면 더 이상 임의로 조작하거나 삭제할 수 없고 지속적으로 잘 보관하고 관리되어 신뢰할만하고 정확하다는 것이다. 이는 ALCOA를 만족시켜야 한다.

ALCOA

• Attributable (출처): 데이터를 작성한 사람, 날짜, 시각 등을 확인할 수 있어야 함.
• Legible (가독성): 데이터 항목을 읽고 이해할 수 있어야 함.
• Contemporaneous (동시성): 데이터는 활동이 이루어지는 당시에 기록되어야 함.
• Original (원본): 데이터는 최초 기록 또는 진본이어야 함.
• Accurate (정확성): 데이터는 일어난 일을 반영해야 함.

건 당국은 모든 데이터가 신뢰할만하며 정확하길 요구하는데, CGMP 규정과 가이드라인은 data integrity문제를 예방하고 감지하기 위해 유연하고 위험에 기반한 전략을 취하는 것을 허용한다. 회사는 공정에 대한 이해와 지식에 기반하여 data integrity를 관리할 의미있고 효율적인 전략을 시행해야 한다. 이러한 전략은 설계와 운영, 환자, 공정, 제품에 대한 위험분석에 기반한 시스템 모니터와 통제를 고려한 것이어야 한다. 경영진은 이러한 전략에 참여하고 영향을 발휘해야 하며.. quality culture

The agency recommends that audit trails that capture changes to critical data be reviewed with each record and before final approval of the record. Audit trails subject to regular review should include, but are not limited to:

• Change history of finished product test results
• Changes to sample run sequences
• Changes to sample identification; and
• Changes to critical process parameters.

The FDA judges integrity of electronic records and data in part by the effectiveness of a firm’s ability to demonstrate control over audit trials on cGxP systems.

국가행위이론(Act of State Doctrine)은 is a principle in English and United States law which states that every sovereign state is bound to respect the independence of every other sovereign state, and the courts will not sit in judgment of another government's acts or act of any sovereign national done within its own territory.

The doctrine is not required by international law (neither customary international law nor treaty law), but it is a principle recognized and adhered to by United States federal and state courts. In the United States, the rationales for the doctrine include respect for other nations' sovereignty and protection of the U.S. Executive's prerogative in foreign affairs, both of which may be frustrated by a decision issuing from U.S. courts.

The Act of State Doctrine enters consideration most often in cases where a foreign sovereign has expropriated the property of a U.S. national located in that foreign territory (e.g. through nationalization). Rather than pursuing recourse through the courts, United States nationals are to take their claims against foreign sovereign governments to the Executive so that the government can either espouse the claims of all U.S. nationals as a group or seek recourse through diplomatic channels. The United States employs the Act of State Doctrine more broadly and with more frequency than other countries.

Background

The Act of State Doctrine, which arose out of colonial practice in the 17th Century, entered into American jurisprudence in the case Underhill v. Hernandez, 168 U.S. 250 (1897). In an 1892 revolution, General José Manuel "Mocho" Hernández expelled the existing Venezuelan government and took control of Ciudad Bolivar, where plaintiff Underhill lived and ran a waterworks system for the city. Underhill, an American citizen, repeatedly applied to Hernandez for an exit passport, but his requests were refused, and Underhill was forced to stay in Ciudad Bolivar and run the waterworks. Hernandez finally relented and allowed Underhill to return to the United States, where he instituted an action to recover damages for his detention in Venezuela. In finding for the Defendant, a New York Court determined that Hernandez had acted in his official capacity as a military commander so his actions were those of the Venezuelan government. The Court therefore refused to hear Underhill's claim against the government based on the Act of State Doctrine. The Court reasoned, "Every sovereign state is bound to respect the independence of every other sovereign state, and the courts of one country will not sit in judgment on the acts of the government of another, done within its own territory."

Banco Nacional de Cuba v. Sabbatino

In Banco Nacional de Cuba v. Sabbatino, 376 U.S. 398 (1964), the United States Supreme Court applied the Act of State Doctrine even where the state action likely violated international law. The case arose when Cuba nationalized its sugar industry, taking control of sugar refineries and other companies in the wake of the Cuban revolution. A large number of Americans who had invested in those companies lost their investments without compensation when the Cuban government assumed control. However, despite the loss suffered by United States nationals, the Supreme Court upheld the Act of State Doctrine by assuming the validity of Cuba's domestic action and therefore rejected the claim of US nationals against Cuba for their lost investments.

The Sabbatino Court stated that although the Doctrine is not found in the Constitution, explicitly or implicitly, it does have "constitutional underpinnings" in the concept of separation of powers. The Supreme Court reasoned that because the Executive had exclusive authority to conduct foreign affairs with other nations on behalf of the United States, disputes arising from the official actions of foreign sovereign powers should not be settled by the Judiciary because those decisions could interfere with the Executive's conduct of foreign affairs.

Second Hickenlooper Amendment

In response to the outcome of the case, Congress enacted 22 U.S.C. § 2370, more commonly referred to as the "Second Hickenlooper Amendment", named after the bill's sponsor, Bourke B. Hickenlooper, an Iowa Senator. Generally, under the Hickenlooper Amendment, courts are not to apply the Act of State Doctrine as a bar against hearing cases of expropriation by a foreign sovereign. There is an exception if the Executive requests that the courts consider the Act of State Doctrine because foreign policy interests may be damaged by judicial interference:

"this subparagraph shall not be applicable . . . (2) in any case with respect to which the President determines that application of the act of state doctrine is required in that particular case by the foreign policy interests of the United States and a suggestion to this effect is filed on his behalf in that case with the court."

English law

The foreign act of state doctrine applies in English law. In April 2018, the English Commercial Court ruled that it also applies in English arbitration.

See also

• Comity
• Rule against foreign revenue enforcement

External links

• A Brief Primer on International Law With cases and commentary. Nathaniel Burney, 2007.
• Official UN website on International Law
• Official website of the International Court of Justice