We develop our products according to the GAMP5 requirements and ISO 9000 standard.
Nine out of 10 of our clients report our products and services as outstanding, according to our recent poll in 2016. The rest are completely satisfied.
We are proud of our service and product’s quality.
Computer system validation is the key activity in development, implementation, and maintenance of our software products.
Validation is an integral part of the computer system life cycle, from the planning stage to the stage of retirement. This is clearly stated in Annex 11 of the European GMP and the FDA’s “General Principles of Software Validation.”
By validating your computer system you confirm that the system is functioning properly and according to the requirements specifications, which is important for data consistency and reliability.
Our certified experts can help perform validation through all stages of the validation process:
- Assistance in creating user requirement specifications
- Performing risk assessment
- Creating functional and design specification
- Assistance through DQ, IQ, OQ, and PQ
- Creating validation reports.
We are trained and experienced in the validation of computerised systems according to GAMP®5 principles, and by introducing practical approaches we can help you decrease the costs of the validation process.
Nanokinetik Quality Management System
Our Quality System is certified according to the ISO 9001 international standard.
This standard covers both core and support business processes. The certified quality management system gives you the assurance that the products and services we deliver are well-managed and documented.
Everyone at Nanokinetik is highly devoted to quality in all aspects of our business – development, implementation, validation, and support services.
Our satisfied customers are the proof of the quality of products and services we deliver.