Novatek International

Novatek International builds quality software for pharmaceutical, biotech and other regulated healthcare manufacturers. It has worked in this field since 1996 and sells applications that can run alone or be linked together. Its products target sterile and non-sterile manufacturing alike.

What Novatek International offers

• Environmental monitoring — software for microbiological monitoring, from sampling plans and scheduling to excursions, trending and reporting.
• Stability management — handling study protocols, pull schedules, storage conditions, testing and shelf-life evaluation.
• Water and utility monitoring — sampling and testing data, trending and change control for systems such as purified water.
• LIMS — laboratory information management with modules that customers add as needs grow.
• Cleaning validation — one of its popular applications.
• Implementation support — deployment, training, integrations, equipment interfacing and validation documents.

Who it works with

Regulated pharmaceutical operations, biotech firms and healthcare manufacturers, with installations around the world. One published case describes Sanofi Genzyme digitising its monitoring.

Key facts

• Founded: 1996
• Standards: supports EU GMP Annex 1 contamination control expectations