This whitepaper discuss why standalone instruments cannot be 21 CFR Part 11 compliant and the importance of ensuring reliable electronic records and electronic signatures in computerized systems.
主页 产品 溶出度 21 CFR Part 11 Compliant 21 CFR Part 11 Compliant 中国总部 | 其他分公司 北京市朝阳区望京北路 3 号 100102 全球电子邮件 +86 800-820-3278 +86 400-820-3278 全球联系电话 关于安捷伦 新闻中心 公司信息 投资商关系 工作 社会关系 与安捷伦合作 大学关系 环境、社会和公司治理 ...
MasterControl's FDA 21 CFR Part 11 Compliant Quality System MasterControl has developed state-of-the-art document control and quality management solutions that are 100% compliant with FDA 21 CFR Part 11 regulations. MasterControl's solution features provide the following benefits: Part 11 Section ...
21 CFR Part 11 Compliant Cutting Edge Technology By AlexanderwerkAlexanderwerk, Inc
Benefits of 21 CFR Part 11 Compliant Software Data Integrity and Security 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 ...
21 CFRPart11概述 2121 CFRPart11内容解读CFRPart11应用 什么是21CFRPart11 美国法规 CFR=CodeofFederalRegulations美国联邦法规21章第11款电子记录和电子签名http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=11 概述 1997年8月20日颁布实施的法规适用于包括现有...
CFRPart11概述 21 CFRPart11内容解读CFRPart11应用 21 21 CFRPart11概述 2121 CFRPart11内容解读CFRPart11应用 什么是21CFRPart11 美国法规 CFR=CodeofFederalRegulations美国联邦法规21章第11款电子记录和电子签名http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfr...
Part 11. It enables users to create complex barcodes such as the 2D DataMatrix barcode, Health Industry Bar Code (HIBC), GS1 Databar, and more. Ensure a secure and compliant process by establishing user permissions and applying electronic signatures to your labels throughout their entire ...
Features • 0 to +100%RH Measurement Range • -35 to +80°C (-31 to +176°F) Measurement Range • Dew point indication via Windows control software • Operation is 21CFR Part 11 compliant • USB Interface for Set-up and Data Download • User-Programmable Alarm Thresholds for ...
Tamper-proof and paperless documentation in accordance with GMP The FDA CFR 21 Part 11 regulations of the American Food and Drug Administration (FDA) are the international industry-wide standard for the digital documentation of medical technology, medica