Nova-CVM Reviews & Product Details

Nova-Cleaning Validation software 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.

Novatek International is a company that specializes in providing compliant software solutions and services to pharmaceutical and biotech industries around the world. The company is known for its innovative approach to automating and managing quality, compliance, and regulatory processes. Novatek's products help organizations enhance operational efficiency, improve quality, and ensure regulatory compliance.Their suite of software solutions is designed to handle various aspects of the pharmaceutical manufacturing and quality control lifecycle, including environmental monitoring, sterility test management, stability studies, cleaning validation, and more. Novatek's commitment to continuous improvement and customer support ensures that their clients receive not only cutting-edge technology but also expert guidance and service.