Novatek International software

A holistic and process-specific risk mitigation system. Nova-Cleaning Validation significantly enhances product integrity by managing changes and assessing the risks associated with cross-contamination and product impurities within a dynamic production environment. All changes to methods, APIs, products, equipment, and family groups are automatically evaluated to ensure product integrity and regulatory compliance. Nova-Cleaning Validation complies with 21 CFR Part 11 and EU Annex 11. The system uses a risk-based approach and is designed based on PDA Technical Reports 29 and 49, ISPE MaPP, 21 CFR Part 211.67.

The Novatek Environmental Monitoring (EM) Software Solution is an industry proven standard with over 20 years of industry use, for managing controlled environments. As a true “Off the Shelf” solution, the core of our Environmental Monitoring software has evolved in response to years of user specifications, and regulatory requirements, through a continuous improvement process. The result is a powerful and compliant solution, designed to evaluate, manage, and reduce the risks associated with everyday Environmental Monitoring.

Monitoring the quality of incoming water and gases is critical for the quality of the finished product. Water is used in several areas of pharmaceutical production (i.e. rinsing, cleaning and a component of the product) and if contaminated can lead to poor quality product. The same applies to gasses used in production. This increases risk of adverse patient reaction from the final product and that may lead to regulatory citations.

Novatek Environmental Monitoring Mobile effectively executes the real-time labeling (barcode), collection, and tracking of environmental monitoring samples in the cleanroom environment. The EM Mobile module is comprised of the software, a rugged wireless tablet PC, wireless barcode scanner, wireless barcode printer and mount that can be used to store and transport sampling media and equipment in the cleanroom. All hardware is cleanroom ready and can be sanitized using standard chemical disinfectants without harming the devices. Our EM Mobile system is integrated with Novatek Environmental Monitoring providing a paperless cleanroom data management system for the entire environmental monitoring process.