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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:

  • AUS TGA: PIC/S PE 009-13 1 Jan 2017 Guide to Good Manufacturing Practice for Medicinal Products
  • US FDA: 21 CFR Part11 (1997) Pharmaceutical, biotech, and Medical Device Industry

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