NOVA-CVM

NOVA-CVM (Cleaning Validation Management) by Novatek International is an automated cleaning validation and risk management software designed for pharmaceutical manufacturers. It significantly enhances product integrity by managing changes and assessing the risks associated with cross-contamination and product impurities within dynamic production environments. The system is built on a risk-based approach and is designed in accordance with PDA Technical Reports 29 and 49, ISPE MaPP, and 21 CFR Part 211.67, while maintaining full compliance with 21 CFR Part 11 and EU Annex 11.

NOVA-CVM replaces time-consuming and error-prone manual processes with a holistic, process-specific risk mitigation system. All changes to methods, APIs, products, equipment, and family groups are automatically evaluated to ensure ongoing product integrity and regulatory compliance, enabling teams to maintain complete contamination control across complex production environments.

Unique and Innovative Features

• Computerized Worst Case Evaluation: Risk factors including dosage, toxicity, cleanability, solubility, and more can be defined together or separately, giving users complete control over evaluation settings. The worst case is determined and displayed for all validation groups, and the assessment is automatically triggered whenever any validation group property is changed.
• Fully Automated MAC Calculations: Carryover limits are calculated for all sample points covering APIs, cleaning agents, and microbial testing. Hundreds of Maximum Allowable Carryover (MAC/MACO) formulas are executed in seconds rather than hours. Calculations account for all possible product A and product B combinations across affected equipment trains and validation groups, with the lowest MAC values highlighted for quick user review.
• Process-Dedicated Change Evaluation: This feature consolidates the impact of multiple changes into a single snapshot of risks and consequences. It covers changes to equipment, introduction of new products, modifications to batch sizes, and any other factor relating to product and equipment families that are part of equipment trains and validation groups.
• System-Defined Protocols: Sampling plans are automatically generated for validation groups, reducing manual effort and ensuring consistency.
• Comprehensive Reporting: Users can quickly retrieve in-depth standard reports and statistical analysis to support review and compliance activities.

Key Benefits

• Fast return on investment through significant time savings over manual processes
• Data security ensured through 21 CFR Part 11 compliance
reduced errors via a fully paperless system
• Improved efficiency through electronic management and approval of master data
• Real-time identification of risks associated with changes in the production environment

Regulatory and Compliance Framework

• Compliant with 21 CFR Part 11 and EU Annex 11
• Designed based on PDA Technical Reports 29 and 49
• Aligned with ISPE MaPP and 21 CFR Part 211.67
• Supports science-based, health-based, and risk-based limit calculations including MAC, MACO, and MSC methodologies

NOVA-CVM is part of Novatek International's broader contamination control product suite, which also includes Environmental Monitoring, Water and Utility Monitoring, and Disease Control and Hygiene software solutions. Together, these tools provide a comprehensive platform for contamination control and compliance management in pharmaceutical and life sciences manufacturing environments.