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Regulatory Compliance

With the advent of global manufacturing, companies are now required to comply with a number of international standards, these include:

  • US FDA (1997): Pharmaceutical Industry
  • US GPEA Guidelines (2000): Government Paperwork Elimination Act
  • US FDA 21 CFR Part 11 (2001): Pharmaceutical, Biotech, and Medical Device Industry
  • US FDA (2002): Bio-Terrorism ActFDA, USDA, US EPA (2002): Food & Beverage Industry
  • HACCP (2002): Food Processing Operations
  • EFSA: European Food Safety Authority
  • US ATF: Bureau of Alcohol Tobacco & Firearms

The key regulation requirements effecting manufacturing in Australia include US FDA 21 CFR Part 11 (2001), HACCP (2002) and EFSA.

An MES solution can help you address the primary regulation requirements by providing track and trace, genealogy, e-signature and compliance services.