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Will 21 CFR 11 Hinder My Compliance Efforts?

March 31st, 2015 by

Electronic Records ManagementElectronic records are complex by nature. While they ostensibly serve as evidence of compliance efforts and regulatory adherence, [...] Read More

What Should Drive Your FDA Medical Device Compliance Efforts?

March 27th, 2015 by

Medical Device ComplianceHow do your compliance efforts impact the profitability of the goods you produce? Medical device manufacturers must comply with FDA standards to spread their products to as many markets as possible.

While [...] Read More

Deciphering EU Cybersecurity Plans and Policies

March 25th, 2015 by

Cyber SecurityBy default, your desire to market products in Europe makes EU cybersecurity compliance one of your primary organizational goals. Unfortunately, the path to effective regulatory adherence [...] Read More

GxP-CC Completes GMQA’s Electronic Data Integrity Certification Training

March 3rd, 2015 by

Data Integrity Compliance TrainingTeam members of GxP-CC consultants have completed the full session of the Data Integrity Training Program in San Diego, CA, including a Train-the-Trainer session. The training entailed all aspects of regulatory requirements and perspectives concerning Data Integrity in the Life [...] Read More