FDA withdraws pharmaceutical guidelines on electronic records

Article Abstract:

The United States Food and Drug Administration (FDA)has withdrawn enforcement guidelines for the Code of Federal Regulations (21 CFR Part II), laws regulating how pharmaceutical manufacturers may use electronic signatures and records. The agency issued a new draft document of these guidelines in an effort to reduce the amount of electronic records under regulation.

Pharmaceutical industry, Company systems management, Information management, Digital signatures, Digital signatures (Authentication), Electronic records, Digital signature

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Irradiation nation: can electron beams and X-rays make our food safe?

Article Abstract:

The US Food and Drug Administration (FDA) is likely to approve irradiation for almost all food sold throughout the country. Irradiation facilities are also being constructed in other countries, such as Brazil, Saudi Arabia and Vietnam.

Strategy & planning, Forecasts, trends, outlooks, Planning, Usage, Forecasts and trends, Market trend/market analysis, United States. Department of Agriculture, Company business planning, War on Terrorism, 2001-, Radiation preservation of food, Food irradiation

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Alarm management for regulated industries

Article Abstract:

The safety and environment regulatory requirements for alarm management are discussed. The practices and challenges faced by automation venders in helping customer implement more effective process alarm systems are also discussed.

Analysis, Environmental aspects, Process control, Electric alarms, Alarms

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