版次CFR 標題 21 概觀美國聯邦法規 (CFR) 包含美國聯邦政府執行部門和機構的規則和法規。 CFR 的 50 個標題中的每一個都會處理不同的管制區域。在《美國食物與藥物管理》 (、) 、美國國家藥物管理局和國家藥物控制政策辦公室的管轄下,所有在 美國 中製造或取用的 CDC CFR 標題 21 會規範食物和藥物。 CFR 標...
FDA CFR タイトル 21 の概要 連邦規則コード (CFR) には、米国連邦政府の執行部および機関の規則と規制が含まれています。 CFRの50タイトルのそれぞれは、異なる規制領域に対処します。 FDA CFR Title 21は、食品医薬品局 (FDA)、薬物取締局、および国家医薬品管理政策局の管轄下にある、米国で...
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Focuses on the United States Food and Drug Administration's (FDA) Rule 21 CFR Part 11 which provides criteria for acceptance by the FDA of electronic records and electronic signatures. Basic two parts of part 11; When records must be kept electronically; Importance of security of laboratory ...
Substituting paper records and handwritten signatures with electronic records and electronic signatures is a must for medical device manufacturers to achieve fast compliance with FDA 21 CFR Part 11. With Polarion's template you can exceed the requirement out-of-the-box....
LABELING SOFTWARE FOR FDA 21 CFR PART 11 Regulatory compliance through label management LABEL ARCHIVE for label Storage & security Multi-stage approval of label designs by reviewers Establish permissions to control access Keep record of changes, comments, revisions, and print history of every label ...
21 CFR Part 11 is a regulation that defines the criteria for ensuring trustworthy and reliable electronic records and electronic signatures in computerized systems of FDA regulated pharmaceutical industries. It is only meaningful for instruments connected to a computer and using software. ...
内容提示: December 21, 2011 21 CFR Part 11 Compliance Approval Processes, Security, Technology and 21 CFR Part 11 For anyone automating regulatory compliance document flows, there's clearly a challenge in defining what's required to conform to 21 CFR Part 11. When applying 21CFR Part 11 ...
21 CFR Part 11 compliancemaintainsthe integrity of electronic recordsandsignaturesto ensure that data isaccurate, reliable,and complete. Incomplete or inaccurate data records can lead toissues of quality or safety concerns for patients. Regulatory Compliance ...