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21 CFR Part 11 Regulations

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Part 11, Electronic Records; Electronic Signatures Scope and Application
This Draft Guidance for Industry is intended to describe the Food and Drug administration's (FDA's) current thinking regarding the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures. FDA

 2003-08-20   PDF PDF file (220 KB) 

Part 11, Electronic Records; Electronic Signatures - Scope and Application
This Draft Guidance for Industry is intended to describe the Food and Drug administration's (FDA's) current thinking regarding the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures. FDA

 2003-02-20   PDF PDF file (44 KB) 

Withdrawal of Draft Guidance for Industry on Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records
The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance entitled ''Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records.'' Federal Register / Vol. 68, No. 23 / Tuesday, February 4, 2003 / Notices

 2003-02-04   PDF PDF file (38 KB) 

21 CFR Part 11; Electronic Records; Electronic Signatures; Maintenance of Electronic Records
This draft guidance presents key principles and practices and addresses some frequently asked questions, but it is not intended to cover everything about maintaining electronic records. The guidance provides two examples of approaches to electronic record maintenance. FDA

 2002-07-01   PDF PDF file (184 KB) 

Providing Regulatory Submission in Electronic Format - ANDAs
This is one of a series of guidance documents intended to assist applicants making regulatory submissions in electronic format to the Center for Drug Evaluation and Research (CDER) and to the Center for Biologics Evaluation and Research (CBER).

 2002-06-20   PDF PDF file (29 KB) 

General Principles of Software Validation; Final Guidance for Industry and FDA Staff
This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0, supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June 9, 1997.

 2002-01-11   PDF PDF file (165 KB) 

Statement by the National Archives and Records Administrationon the U.S. Court of Appeals decision on General Records Schedule 20


 2001-12-21   PDF PDF file (10 KB) 

Establishment of Electronic Reporting: Electronic Records
EPA is proposing to allow electronic reporting to EPA by permitting the use of electronic document receiving systems for the reception of electronic documents in accordance appropriate document submission requirements covered by EPA regulations, US. Environmental Protection Agency

 2001-08-31   PDF PDF file (239 KB) 

21 CFR Part 11 Electronic records electronic signatures - Glossary of Terms
The purpose of this draft guide is to define those terms that will be used in the Food and Drug Administration's (FDA's) preamble describing their current thinking on the principles and procedures for creating, modifying, maintaining, archiving, retrieving, and transmitting electronic records and electronic signatures, in accordance with the provisions of 21 CFR Part 11, the Code of Federal Regulations applicable to Electronic records; Electronic Signatures.

 2001-08-01   PDF PDF file (119 KB) 

Providing Regulatory Submission in Electronic Format - Postmarketing Expedited Safety Reports
This guide discusses the general issues relating to the electronic submission of post-marketing expedited safety reports for (1) drug products marketed for human use, together with new drug applications (NDAs) and abbreviated new drug applications (ANDAs), (2) prescription drug products marketed for human use without an approved NDA or ANDA, and (3) therapeutic biological products marketed for human use with biologic license applications (BLAs). This guide does not apply to vaccines, FDA

 2001-05-01   PDF PDF file (39 KB) 

Engineering Principles for IT Security (A baseline for achieving security)
This document is published by the National Institute of Standards and Technology (NIST) as a recommended guide for Federal departments and agencies. It is intended for use by government agencies, and also within the private sector. Its goal is to set out principles that will equally apply to all systems, and not just those used specifically in technology areas, NIST

 2001-02-01   PDF PDF file (118 KB) 

Uncitral Model Law on Electronic Signatures with Guide to Enactment
As approved by the UNCITRAL Working Group on Electronic Commerce at its thirty-seventh session, held at Vienna from 18 to 29 September 2000, United Nations Commission on International Trade Law

 2001-01-30   PDF PDF file (149 KB) 

Securing Electronic Government
This guide discusses issues relating to the electronic submission of advertising and promotional labelling of materials for prescription drug and biological products, including launch materials, FDA

 2001-01-19   PDF PDF file (161 KB) 

Providing Regulatory Submission in Electronic Format - ANDAs
This guide discusses issues relating to the electronic submission of abbreviated new drug applications (ANDAs), including supplements and amendments to those applications. FDA

 2001-01-11   PDF PDF file (30 KB) 

Providing Regulatory Submission in Electronic Format - Prescription Drug Advertising and Promotional Labeling
This guide discusses issues relating to the electronic submission of advertising and promotional labelling materials for prescription drug and biological products, including launch materials, FDA

 2001-01-01   PDF PDF file (28 KB) 

Legal Considerations in Designing and Implementing Electronic Processes: A Guide for Federal Agencies
The purpose of this Guide is to identify legal issues that agencies are likely to encounter when converting to electronic processes; and to provide suggestions on how to address them, U.S. Department of Justice

 2000-11-01   PDF PDF file (450 KB) 

Electronic Signatures in Global and National Commerce Act
An Act to facilitate the use of electronic records and signatures in interstate or foreign commerce.

 2000-10-01   PDF PDF file (139 KB) 

Implementation of the Government Paperwork Elimination Act
Procedures and Guidance, Federal Register / Vol. 65, No. 85 / Tuesday, May 2, 2000 / Notices

 2000-02-05   PDF PDF file (175 KB) 

Electronic Common Technical Document Specification
The ICH M2 Expert Working Group has defined, in the current document, the specification for the Electronic Common Technical Document (eCTD).

 2000-01-01   PDF PDF file (17 MB) 

Records Management Guidance for Agencies Implementing Electronic Signature Technologies
An agency's decisions on how to adequately document program functions, risk assessment methodologies, and its records management practices are essential and interrelated aspects of an electronic signature initiative, National Archives and Records Administration

 2000-01-01   PDF PDF file (83 KB) 

Directive 1999/93/EC of the European Parliament and of the Council on a Community Framework for Electronic Signatures
The European Parliament and the Council of the European Union

 1999-12-13   PDF PDF file (126 KB) 

Electronic Signatures in Global and National Commerce Act (Referred in Senate)
An act to facilitate the use of electronic records and signatures in interstate or foreign commerce, The Senate of the United States

 1999-10-11   PDF PDF file (28 KB) 

Preparing Data for Electronic Submission in ANDAs
This guidance is intended to provide assistance to applicants submitting data in electronic format to the Office of Generic Drugs (OGD) in abbreviated new drug applications (ANDAs).

 1999-09-01   PDF PDF file (239 KB) 

United States Court of Appeals for the District of Columbia Circuit
About the Federal Records Act

 1999-08-06   PDF PDF file (185 KB) 

FDA Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures
This guidance document represents the agency's current thinking on what is required to be fully compliant with 21 CFR Part 11, "Electronic Records; Electronic Signatures" and provides that agency decisions on whether or not to pursue regulatory actions will be based on a case by case evaluation, FDA

 1999-05-13   PDF PDF file (37 KB) 

European Parliament and Council Directive on a Common Framework for Electronic Signatures
The Directive aims at ensuring the proper functioning of the Internal Market in the field of electronic signatures, by creating a harmonised and appropriate legal framework for the use of electronic signatures within the Community. Amended proposal, Brussels

 1999-04-29   PDF PDF file (81 KB) 

Opinion of the Committee of the Regions on the 'Proposal for a European Parliament and Council Directive on a common framework for electronic signatures'
Committee of the Regions, Brussels

 1999-01-14   PDF PDF file (70 KB) 

Providing Regulatory Submission in Electronic Format - General Considerations
This guidance discusses general issues common to all types of electronic regulatory submissions, FDA

 1999-01-01   PDF PDF file (57 KB) 

Providing Regulatory Submission in Electronic Format - NDAs
This guide discusses issues related to the electronic submission of new drug applications (NDAs), supplements and amendments to those applications to CDER.

 1999-01-01   PDF PDF file (218 KB) 

Computerized Systems Used in Clinical Trials
This document addresses issues pertaining to computerized systems used to create, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to the Food and Drug Administration (FDA).

 1999-01-01   PDF PDF file (47 KB) 

Opinion of the Economic and Social Committee on the 'Proposal for a European Parliament and Council Directive on a common framework for electronic signatures'
The aim of the directive is to establish a legal framework for certification services that are available to the public, in other words to make electronic signatures easier to use and to ensure their legal recognition. Economic and Social Committee, Brussels

 1998-12-02   PDF PDF file (72 KB) 

45 CFR Part 142 Security and Electronic Signature Standards
Proposed Rule, Federal Register / Vol. 63, No. 155 / Wednesday, August 12, 1998

 1998-08-12   PDF PDF file (165 KB) 

21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule Electronic Submissions; Establishment of Public Docket; Notice [Docket No. 92N0251]
Final rule, Federal Register/Vol. 62, No. 54/Thursday, March 20, 1997/Rules and Regulations

 1997-03-20   PDF PDF file (258 KB) 

21 CFR Part 11; Electronic Records; Electronic Signatures Electronic Copies of Electronic Records
This draft guidance focuses on furnishing FDA with electronic copies of electronic records that are subject to part 11. It identifies key principles and practices in generating electronic copies of electronic records so that the electronic copies are accurate, complete and suitable for our inspection, review and copying.

 1997-01-01   PDF PDF file (146 KB) 

General Principles of Software Validation
This draft guide outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop or manufacture medical devices.

 1997-01-01   PDF PDF file (154 KB) 

Glossary of Computerized System and Software Development Terminology
This document is intended to serve as a glossary of terminology applicable to software development and computerized systems in FDA regulated industries, FDA

 1995-01-08   PDF PDF file (254 KB) 

Pharmaceutical Industry Software Quality Assistance & Assessment to PDA Technical Report 32
Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations. Summary of the process defined by PDA Technical Report #32

    PDF PDF file (733 KB) 

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21 CFR Part 11 Issues
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