Systems for pharmaceutical companies

Our advanced database systems are designed to collect, analyse, store, and share data related to monitoring/trending of product quality, product stability, and manufacturing environment. We can also provide Product Life Cycle System designed to support the product life cycle according to Annex 15. The solutions are tailored to individual user requirements.

Design, implementation, testing, and validation – in accordance with GMP requirements.

Key functionalities of our systems include:

Scheduling actions on a weekly, monthly, or yearly basis
Generating reports of actions/studies planned for a given timeframe
Automatic notifications of upcoming activity deadlines
Integration of all data critical for quality into a central database
Data security – access rights management
Data integrity ensured by tracking and recording of all database modifications (Audit Trail)
Statistical analysis results easily available for key personnel
Easy and intuitive information/data search
Monitoring of results and trends in critical quality data
Alerts for results exceeding predefined limits