About Novatek International
Quality software built by industry specialists
Since 1996, Novatek has developed quality, manufacturing and contamination control software for the teams responsible for product release. The company was founded by a quality director who could not find a system that fit his own process.
Our Origin
Why Novatek was founded
In the mid-1990s, one of Novatek's founders was a quality director at a pharmaceutical manufacturer. The laboratory systems available at the time could record and store results, but they could not enforce specific processes required for stability studies, environmental monitoring, or produce the detailed trending and data analysis that an inspector would request. Much of the process therefore remained on paper and in spreadsheets.
This is how our team of founders was put together; to properly document requirements that truly match the process executed in the quality control lab rather than on a list of software features, and working with trusted engineers, a system was built in accordance to those specifications. Novatek International was founded on that work in 1996. The software has been structured around specific process workflows rather than broad data tables ever since.
Many of the engineers and specialists involved in those early systems remain with the company today.
- Mid-1990s
Stability studies and environmental monitoring still run on paper and spreadsheets.
- 1996
Novatek International founded on the first system built to those specifications.
- Ever Since
Structured around process workflows rather than broad data tables.
- Today
Many of those original engineers are still with the company.
Compliance
Built for environments that get inspected
Any system used in a regulated manufacturing environment must be defensible during an inspection. Novatek is developed, validated and maintained on that basis.
Development and quality management
Software developed according to ISO, GAMP 5 and cGEP
Independently audited for internal quality practices, including cybersecurity
Product compliance
Systems compliant with 21 CFR Part 11 and EU GMP Annex 11 — full audit trail, electronic signatures, version control and role-based access across the suite
Developed and compliant with cGMP, ICH and current data integrity regulations from FDA, MHRA and PIC/S
Built to support EU GMP Annex 1 contamination control strategy requirements
Validation deliverables
IQ/OQ protocols provided with every implementation
PQ assistance
21 CFR Part 11 compliance verification
User and installation guides, sample SOPs, training materials and training certification
Deployment
Thin-client and validated cloud deployment options
Data segregation by site and by user role for multi-site rollouts
Our Clients
Used at regulated manufacturing sites worldwide
Novatek systems run at some of the most heavily inspected manufacturing sites in the world — global pharmaceuticals, biotechs, biologics, sterile injectables, medical devices, animal health and consumer health — across North and South America, Europe, Asia, Africa and Australia.
The Company Beyond the Product
Local support in 50 countries
Novatek is headquartered in Montreal, with teams and partners across North America, South America, Europe, Asia, Africa and Australia. Multi-site clients get one system, consistent global configuration, and support in their own time zone.
Industry participation
Novatek staff publish, present and serve as subject matter experts at industry conferences, including PDA. Issues raised in those forums inform our development priorities.
Beyond the software
Novatek supports Hope for Dementia, a charity funding research, education and assistance for mental disorders. Hope for Dementia is a federal non-profit charitable organization whose mission is to support the cause of safeguarding healthy brains in our aging population. Hope for Dementia is dedicated to supporting prevention, early diagnosis and treatment of dementia and other cognitive disorders.
Tell us about your process
Whether you are replacing a system that doesn't meet all your requirements or moving off paper for the first time, the conversation starts the same way: tell us how your process runs.