内容提示: Guidance for Industry Part 11, Electronic Records; Electronic Signatures August 2003Page 1 of 13Guidance for IndustryPart 11, Electronic Records; Electronic Signatures— Scope andApplicationAugust 2003Pharmaceutical CGMPsFDA 工业指南联邦法规 11 分 部分 电子记录和电子签名— 范围和应用2003 年 8...
a吉林省中鼎药业有限公司 In Jilin Province tripod with two handles pharmaceutical industry limited company [translate] a如果你们有设计的款式,也可以发给我们报价。 If you have the design design, also may issue us to quote price. [translate] aThe high cost of raw materials is keeping prices up 原...
Supporting the Pharmaceutical Industry with 21 CFR Part 11 Compliance ReadinessPANalytical BV
Our qualification approach is also based on industry best practices, including the International Society for Pharmaceutical Engineering (ISPE) GAMP series of Good Practices Guides and the Pharmaceutical Inspection Cooperation Scheme (PIC/S) Good Practices for Computerized Systems in Regulated GxP ...
最新-21-CFR-PART-11-企业指南---中英对照[1]Guidance for Industry Part 11,Electronic Records;Electronic Signatures August 2003 Page 1of 13Guidance for Industry Part 11,Electronic Records;Electronic Signatures —Scope and Application August 2003Pharmaceutical CGMPs FDA 工业指南联邦法规11部分电子记录和电子...
美国FDA 指导原则 符合21 CFR第4部分工业指南的某些眼科产品政策 英文原版.pdf,Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry This guidance is for immediate implementation. FDA is issuing this guidance for i
Process transformation for better IT service delivery in the pharmaceutical industry The need for computer system validation further adds to costs. Thus, on the one hand, the pharmaceutical industry is trying to leverage technology-driven ... K Biswas 被引量: 3发表: 2007年 Chemistry, Manufacturing...
内容提示: Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application August 2003 Pharmaceutical CGMPs FDA 工业指南 规 联邦法规 11 部分 电子记录和电子签名 — 范围和应用 2003 年 8 月 药物 CGMPs TABLE OF CONTENTS 目录 I. Introduction ... 2II. Background .....
material technical requirements should be consistent with national standards, industry standards and technical requirements related to the alloy spectrum review should be carried out; 3) pipe supports and hangers part plant product quality certificate for each variable spring supports, constant support hange...
This article discusses the FDA ruling 21 CFR Part II, Regulation on Electronic Records and Electronic Signatures and the status of the industry's readiness... AP Road,A Park,KB Patterson 被引量: 90发表: 2003年 Multi-scale-Reinforced Prepregs for the Improvement of Damage Tolerance and Electric...