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The Role of FDA Benefit-Risk Assessment in Regulatory Decision Making

April 7th, 2015 by

FDA RegulationsPharmaceutical manufacturers can’t sell their products without first convincing regulators of their safety. Firms that fail to do so sustain fiscal losses when they [...] Read More

Meeting Compliance Goals With Deviation Management And CAPA Systems

June 2nd, 2014 by

Deviation ManagementYour firm will experience compliance failures from time to time. In the realm of complex GxP-regulated processes, like automated pharmaceutical manufacturing and medical device quality assurance, things can go wrong with little advance warning.

While it would be nice to prevent such issues [...] Read More

GxP-CC Earns ISO 9001:2008 Certification

May 8th, 2014 by

ISO 9001:2008 Certified IQNetGxP-CC has achieved ISO 9001:2008 certification. Developed by the International Organization for Standardization, ISO 9001:2008 is recognized as the worldwide standard for [...] Read More