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Title 21 CFR Part 11
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21	Use of R in Clinical Trials and IndustrySponsored Medical Research Add to Reading List Source URL: user2007.org Language: English - Date: 2007-09-04 14:51:18 Pharmaceutical sciences Clinical research Pharmacology Food and Drug Administration Medical statistics Clinical trial Validation Title 21 CFR Part 11 Medical research Pharmaceutical industry Health Research
22	21 CFR Part 11 White Paper Version V8.00 SR1 ProLeiT AG Add to Reading List Source URL: www.proleit.com Language: English - Date: 2012-07-30 07:42:23 Government Computer law Food and Drug Administration Pharmaceuticals policy Title 21 CFR Part 11 Electronic signature Validation Electronic Signatures in Global and National Commerce Act Code of Federal Regulations Cryptography Pharmaceutical industry Law
23	DoDSTD, June 19, 2002 Add to Reading List Source URL: jitc.fhu.disa.mil Language: English - Date: 2011-09-20 18:15:47 Information technology management Public records Business Security Records management United States administrative law Title 21 CFR Part 11 Information security Code of Federal Regulations Content management systems Government Administration
24	LabArchives and 21 CFR Part 11 Background and Introduction 21 CFR Part 11 contains the regulations of the US Food and Drug Administration with regard to electronic records and electronic signatures. This document was pre Add to Reading List Source URL: www.labarchives.com Language: English - Date: 2013-03-11 22:22:24 Notary Computer law Electronic signature Key management Title 21 CFR Part 11 Password Electronic Signatures in Global and National Commerce Act Validation Digital signature Cryptography Security Pharmaceutical industry
25	White paper infoRouter in the Life Sciences Industry: 21 CFR Part 11 Compliance Overview of 21 CFR Part 11 The final version of the 21 CFR Part 11 regulation released by the FDA in 1997 provides a Add to Reading List Source URL: www.inforouter.com Language: English - Date: 2015-03-26 12:06:42 Technology Document management system Title 21 CFR Part 11 Electronic signature Password Portable Document Format Validation Active Directory Information security Computing Pharmaceutical industry Information technology management
26	MEDICAL DEVICE Electronic Medical Device Reporting (eMDR) For over a decade, AssurX systems have been used in heavily regulated Add to Reading List Source URL: www.assurx.com Language: English - Date: 2014-08-06 22:08:26 Pharmaceutical industry Pharmaceutical sciences Clinical research Pharmacology MedWatch Title 21 CFR Part 11 Medical device Eye movement desensitization and reprocessing Adverse event Medicine Food and Drug Administration Health
27	Bausch & Lomb customer case study Implementing a Global Add to Reading List Source URL: www.assurx.com Language: English - Date: 2014-08-06 22:02:08 Quality Business Management Validity Bausch & Lomb Validation Title 21 CFR Part 11 Workflow Corrective and preventive action Pharmaceutical industry Technology Medicine
28	U.S. Department of Defense Document: p50152s: Free Downloads Add to Reading List Source URL: www.usa-federal-forms.com Language: English - Date: 2007-02-17 20:04:21 Information technology management Public records Business Security Records management United States administrative law Code of Federal Regulations Title 21 CFR Part 11 Information security Content management systems Government Administration
29	G u i d a n t C a s e S t u d y Add to Reading List Source URL: www.assurx.com Language: English - Date: 2014-08-06 22:02:13 Quality Pharmaceutical sciences Food and Drug Administration Pharmaceuticals policy Title 21 CFR Part 11 Validation Quality management system Corrective and preventive action Guidant Pharmaceutical industry Technology Medicine
30	MEDICAL DEVICE Complaints Management and Regulatory Reporting For over a decade, AssurX systems have been used in heavily regulated Add to Reading List Source URL: www.assurx.com Language: English - Date: 2014-08-06 22:08:35 Health Pharmaceutical industry Clinical pharmacology Pharmacology United States Public Health Service Workflow Title 21 CFR Part 11 Medical device MedWatch Medicine Technology Food and Drug Administration

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