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General

The American National Standards Institute (ANSI) is a private, non-profit organization that administers and coordinates the U.S. voluntary standardization and conformity assessment system. The Institute's mission is to enhance both the global competitiveness of U.S. business and the U.S. quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems, and safeguarding their integrity.

ARMA International is a not-for-profit association that provides education, research, and networking opportunities to information professionals, to enable them to use their skills and experience to leverage the value of records, information, and knowledge as corporate assets and as contributors to organizational success.

Cadalyst magazine is the most complete source for essential information about CAD and related CAM/CAE/PLM technologies in the key market segments of AEC, MCAD and GIS serving an elite audience of 60,000 subscribers. The magazine's objective business and technical reporting and product reviews lead high-level corporate managers, CAD managers and CAD users through management and purchasing decisions to realize higher productivity and profits.

International Organization of Standardization (ISO) is a network of the national standards institutes of 148 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.

The National Society of Professional Engineers (NSPE) is the only engineering society that represents individual engineering professionals and licensed engineers (PEs) across all disciplines. Founded in 1934, NSPE strengthens the engineering profession by promoting engineering licensure and ethics, enhancing the engineer image, advocating and protecting PEs' legal rights at the national and state levels, publishing news of the profession, providing continuing education opportunities, and much more.

The Occupational Safety and Health Administration (OSHA) works to save lives, prevent injuries and protect the health of America's workers. To accomplish this, federal and state governments must work in partnership with the more than 100 million working men and women and their six and a half million employers who are covered by the Occupational Safety and Health Act of 1970.

The U.S. National Archives and Records Administration (NARA) is America's national recordkeeper, a public trust on which our democracy depends. NARA ensures, for the citizen and the public servant, for the President and for the Congress and the Courts, ready access to essential evidence.

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Energy

The American Nuclear Society serves its members in their efforts to develop and safely apply nuclear science and technology for public benefit through knowledge exchange, professional development, and enhanced public understanding.

The U.S. Department of Energy (DOE) advances the national, economic and energy security of the United States; to promote scientific and technological innovation; and to ensure the environmental cleanup of the national nuclear weapons complex.

The Nuclear Energy Agency (NEA) assists its Member countries in maintaining and further developing, through international co-operation, the scientific, technological and legal bases required for the safe, environmentally friendly and economical use of nuclear energy for peaceful purposes.

The Nuclear Energy Institute (NEI) is the policy organization of the nuclear energy and technologies industry and participates in both the national and global policy-making process. NEI’s objective is to ensure the formation of policies that promote the beneficial uses of nuclear energy and technologies in the United States and around the world.

The Nuclear Information and Records Management Association (NIRMA) is a non-profit, professional association established in 1977, which uniquely supports regulated nuclear and selected energy-related industries that must deal with stringent information management regulations. Its goal is to assist individuals and their companies in developing and maintaining the technical foundation required to handle the increased pressures that mark our quickly advancing information age.

The U.S. Nuclear Regulatory Commission (NRC) regulates the Nation's civilian use of byproduct, source, and special nuclear materials to ensure adequate protection of public health and safety, to promote the common defense and security, and to protect the environment.

The United States Energy Association (USEA) is the U.S. Member Committee of the World Energy Council (WEC). USEA is an association of public and private energy-related organizations, corporations, and government agencies. USEA represents the broad interests of the U.S. energy sector by increasing the understanding of energy issues, both domestically and internationally.

The World Energy Council (WEC) is the foremost global multi-energy organization in the world today. WEC has Member Committees in over 90 countries, including most of the largest energy-producing and energy consuming countries. The 80-year-old organization covers all types of energy, including coal, oil, natural gas, nuclear, hydro, and renewables, and is UN-accredited, non-governmental, non-commercial and non-aligned. WEC is a UK-registered charity headquartered in London.

The World Nuclear Association (WNA) is the global industrial organization that seeks to promote the peaceful worldwide use of nuclear power as a sustainable energy resource for the coming centuries. Specifically, the WNA is concerned with nuclear power generation and all aspects of the nuclear fuel cycle, including mining, conversion, enrichment, fuel fabrication, plant manufacture, transport, and the safe disposition of spent fuel.

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Manufacturing / Facilities

The American Society of Mechanical Engineers (ASME) is a nonprofit educational and technical organization that works to promote and enhance the technical competency and professional well-being of its members, and through quality programs and activities in mechanical engineering, better enable its practitioners to contribute to the well-being of humankind.

APICS - The Association for Operations Management is a not-for-profit international educational organization founded in 1957 as the American Production and Inventory Control Society. APICS is respected throughout the world for its education and professional certification programs. With nearly 60,000 individual and corporate members in 20,000 companies worldwide, APICS is dedicated to using education to improve the business bottom line.

The Association for Facilities Engineering (AFE) provides education, certification, technical information and other relevant resources for plant and facility engineering, operations and maintenance professionals worldwide.

The Association for Manufacturing Technology (AMT), founded in 1902, represents and promotes the interests of American providers of manufacturing machinery and equipment. Its goal is to promote technological advancements and improvements in the design, manufacture and sale of members’ products in those markets and act as an industry advocate on trade matters to governments and trade organizations throughout the world.

The International Facility Management Association (IFMA) is the premier professional association for facility management. IFMA was established in 1980 as a not-for-profit, incorporated association dedicated to promoting excellence in the management of facilities. Globally, IFMA spots trends, conducts research, provides educational programs, and assists corporate and organizational facility managers in developing strategies to manage human, facility and real estate resources.

The National Association of Manufacturers (NAM) mission is to enhance the competitiveness of manufacturers by shaping a legislative and regulatory environment conducive to U.S. economic growth and to increase understanding among policymakers, the media and the general public about the vital role of manufacturing to America’s economic future and living standards. The NAM is the nation’s largest industrial trade association, representing small and large manufacturers in every industrial sector and in all 50 states. Headquartered in Washington, D.C., the NAM has 10 additional offices across the country.

Plant Engineering magazine. The problem-solving resource for plant engineers.

The Plant Maintenance Resource Center is the premier web resource for industrial Maintenance professionals. It includes links to maintenance consultants, CMMS and maintenance software, CMMS vendors, maintenance conferences and conference papers, articles on maintenance, and many other valuable resources.

The Society of Manufacturing Engineers (SME) is the world's leading resource Where Manufacturing Comes Together - both people and information - to advance manufacturing knowledge.

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Pharmaceutical

The Biotechnology Industry Organization (BIO) represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.

The GAMP Forum exists to promote the understanding of the regulation and use of computer and control systems within the pharmaceutical manufacturing industry. Whenever possible, GAMP will form relationships with like minded industry associations to create globally harmonized quality standards and will partner with suppliers to identify and share best practices in order to have a positive influence on the quality of computer products used in pharmaceutical operations.

The International Society for Pharmaceutical Engineering (ISPE) is a global, not-for-profit membership organization that provides education, training, and technical publications to Life Science professionals.

The Medical Device Manufacturers Association (MDMA) is a national trade association based in Washington, D.C. that represents independent manufacturers of medical devices, diagnostic products and healthcare information systems.

The National Food Processors Association (NFPA), the principal scientific and technical trade association for the food industry, provides leadership and value to its members on food safety, processing, health and nutrition issues by providing the highest quality of food science and technical expertise, assistance and programs in support of member needs; and translating its food science and technical expertise into public policy strategies and communications programs for assuring favorable issue results.

The PDA advances pharmaceutical and biopharmaceutical technology internationally by promoting scientifically sound and practical technical information and education for industry and regulatory agencies.

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

21 CFR Part 11. Electronic Records; Electronic Signatures; Final Rule Electronic Submissions; Establishment of Public Docket; Notice.
Click here to download the PDF

Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application.
Click here to download the PDF

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