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Novatek International

Saint-Laurent, QC · Canada

Quality & Compliancemid

Specialization: GMP quality software: QMS, LIMS and environmental monitoring

Key Differentiator

Its software is built for sterile and non-sterile GMP manufacturers and supports 21 CFR Part 11 and EU GMP Annex 11 requirements.

Core Services

Nova-QMS quality management; Environmental monitoring software; Stability, raw material and finished product LIMS; Calibration and preventive maintenance software; Cleaning validation management

Capabilities

Quality management system (deviations, CAPA and related records)Environmental and utility monitoringStability study managementCalibration and preventive maintenanceValidation evidence managementContamination control aligned with EU GMP Annex 1

Market Intelligence

Novatek is headquartered in Saint-Laurent, Montreal, with offices in the US, Mexico, Europe, Asia and Oceania. It says it has delivered quality software to regulated pharmaceutical operations since 1996.

Website

www.ntint.com

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