Similar to pharmaceutical companies, biotechnology organizations must comply with regulations in the areas of good laboratory, clinical and manufacturing practices. Harmonized guidelines such as ICH Q7, Guide for Good Clinical Practice or ICH Q8, Guide for Industry: Pharmaceutical Development or ICH Q10, Quality Risk Management may have to be observed in order to meet compliance requirements globally.

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Software Validation and Testing 21 CFR Part 11 Assessment Bioequivalence Research Manufacturing Process Validation Quality Assurance

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Pharmaceutical Software Development Company

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