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...
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.
21CFRPart11requirements. 11.10controlsforclosedSystems 11.10(a) •Validationofsystemstoensureaccuracy,reliability,consistentintendedperformance,andtheabilityto discerninvalidoralteredrecords •SolidWorksEnterprisePDMmanagesrecordsandversionsthemeachtimetheyarecheckedin.Uponcheck-in ...
21 CFR Part 11是针对电子记录和电子签名的FDA法规，对于药厂和医疗器械使用的众多电子记录和电子签名提供了详尽的要求和规范。Subpart A--General Provisions A部分—通用规定 11.1 Scope.11.1 范围 (a) 本部分的法规制定了接受标准，用于机构评估电子记录、电子签名、电子记录加手写签名的可信性、可靠性，以及...
The Software Development Life Cycle steps and the Computer Validation steps that were used in developing InstantGMP™ MES, InstantGMP™ VAPE, InstantGMP™ MD and InstantGMP™ PRO assure compliance with 21 CRF part 11 requirements for closed systems. ...
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.
11.100 General requirements.一般要求 Subpart C—Electronic Signatures电子签名 11.200 Electronic signature components and controls.电子签名组件和控制 Subpart C—Electronic Signatures电子签名 11.300 Controls for identification codes/passwords.识别码/密码的控制 ...
User Bulletin: Memory Upgrade Requirements for 7500 Software v2.0 (English) Quick Reference: RapidFinder Express Software Version v2.0 User Bulletin: Installation of Applied Biosystems RapidFinder Express Software v2.0 and SDS Software v1.4.2.1 ...
FDA 21 CFR Part 11 compliance is crucial for organizations handling electronic records and signatures. AssurX software provides the necessary controls and configurations to meet these regulatory requirements. This white paper explores how our software supports compliance with FDA 21 CFR Part 11, enhancin...
2100 expert security pack A powerful software supporting 21 CFR Part 11 requirements Take advantage of the digital data and speed up review and release processes. Benefit from the many advantages of the Agilent 2100 bio- analyzer and the 2100 expert soft- ware combined with the superior 2100 ...