The ComSoft 21 CFR Part 11 software means you get validatable software for programming and readout of Testo data loggers and for archiving data. It fulfils all the FDA's 21 CFR Part 11 requirements.
Attune NxT Software 21 CFR Part 11 is for use with the Attune NxT Acoustic Focusing Cytometer and supports compliance with 21 CFR Part 11 FDA guidelines for security, auditing, and electronic (SAE) signatures using an SAE console. The software helps
21 CFR Part 11 compliance is supported by STARe thermal analysis software. Part 11 gives detailed guidelines on how to manage electronic records and electronic signatures in order to maintain accuracy and security.
21 CFR Part 11 (Part 11)1 applies only to those records “that persons create, modify, maintain, archive, retrieve, or transmit under any records or signature requirement set forth in the Federal Food, Drug, and Cosmetic Act (the Act), the Public Health Service Act (PHS Act), or any ...
Specification sheet | Qubit Flex SAE Software 21 CFR Part 11 compliance Qubit Flex SAE Software for 21 CFR Part 11 support The FDA issued the Electronic Records and Signatures Rule known as 21 CFR Part 11 in August 1997 [1]. This rule defines the requirements for use of electronic ...
The FDA released the Electronic Records and Signatures Rule, known as 21 CFR Part 11 in August 1997.* This rule defines the requirements for use of electronic documents in place of paper documents. The law specifies the...
Metal detection software complies with 21CFR part 11Metal detector specialist Lock Inspection Systems has collaborated with industry experts to develop software that enables metal detection systems to deliver highly accurate inspection of tablets, capsules and granules while at the same time meeting the ...
A centralized solution for 21 CFR Part 11 label creation, printing, tracking, and approval Want to see a demo of TEKLYNX CENTRAL CFR in action? REQUEST DEMO Get your questions answered and find out if TEKLYNX CENTRAL CFR is right for you. ...
摘要 31:32 分钟 语言:English 产品 热分析超越系列 使用我们全面的仪器组合、功能强大的软件以及多种配件和坩埚进行材料表征。 热分析软件 STARe 超越系列 由于采用模块化设计,STARe 具有很大的灵活性,允许用户根据其当前和未来的需要量身打造测试方案。
For regulated GxP documents, CFR Part 11 outlines specific FDA requirements for the use of electronic signatures. In order to comply with CFR Part 11, electronic signatures must include: The printed name of the signer The date and time the signature was executed A unique user ID Digital adopted...