BIOVIA provides a scientific collaborative environment for advanced biological, chemical and materials experiences that allows science-driven companies access, organize, analyze and share data in unprecedented ways throughout the product lifecycle in regulated and non-regulated environments. BIOVIA’s sophisticated enterprise portfolio of Scientific Informatics, Molecular Modeling & Simulation, Data Science, Laboratory Informatics, Formulation Design, Quality & Compliance and Manufacturing Analytics helps drive innovation, increase productivity, improve quality and compliance, reduce costs and accelerate time to market.
Digital Laboratory Informatics capabilities allow for compliant and efficient lab workflows, harmonization and standardization.
Rely on BIOVIA as you trusted partner to meet regulatory requirements
According to GAMP 5 Software Categories, BIOVIA’s solutions fall under the category 4, configurable software. BIOVIA’s solutions are designed to enable compliance with different regulations like US FDA 21 CFR Part 11 and EU Annex 11.
Download the BIOVIA Quality Statement here to see a high level overview of our approach to Quality.
Regulatory checklists for risk assessment and reduction of validation efforts are available on request.