Automated cleaning validation and contamination control software for pharmaceutical manufacturing. 21 CFR Part 11 and EU Annex 11 compliant with computerized risk-based worst-case evaluation and automated MAC calculations.
Nova-CVM (Nova-Cleaning Validation) is cleaning validation software from Novatek International, part of its Contamination Control Suite with 20+ years of pharmaceutical industry use. The vendor states it speeds up the cleaning validation process, produces accurate results, and reduces non-compliance risk.
The platform automates worst-case determination and MAC (Maximum Allowable Carryover) calculations, executing hundreds of calculations in seconds instead of hours. Risk factors including dosage, toxicity, cleanability, solubility, and more can be defined together or separately, allowing complete control over evaluation settings. Worst case is determined and displayed for all validation groups.
Key capabilities include automated sampling protocol generation, process-dedicated change evaluation that consolidates the impact of multiple changes, and full traceability of all validation activities. The dedicated Risk Control feature consolidates the impact of process changes including changing equipment, introducing new products, modifying batch sizes, and factors that affect product and equipment families.
Designed per PDA Technical Reports 29 and 49, ISPE MaPP, 21 CFR Part 211.67, Validation of Cleaning Processes (7/93), and EU Annex 15. The vendor states ROI is almost immediate, with time and resource savings compared to manual processes: hours of work accomplished in minutes through automation.
Pharmaceutical Edition
Nova-CVM is pharma-specific by design. The product is built for GMP-regulated pharmaceutical and biotech manufacturing environments. Compliant with 21 CFR Part 11 and EU Annex 11. Designed based on PDA Technical Reports 29 and 49, ISPE MaPP, 21 CFR Part 211.67, and EU Annex 15 cleaning validation standards.
Core Capabilities
FDA & GxP Compliance
International Standards
Data Integrity & Validation
Web-based interface accessible via modern browsers. 21 CFR Part 11 compliant architecture providing data security and compliance. Part of Novatek's Contamination Control Suite which integrates with Environmental Monitoring and Utilities Monitoring modules.
Software designed for pharmaceutical manufacturing environments with automated calculations and paperless workflows. Integrates with existing manufacturing systems and can work alongside MasterControl QMS through partnership integration. Deployment options (cloud vs on-premise), API availability, and technical requirements are undisclosed.
Pricing is undisclosed; quotes are available directly from Novatek International. Software is available as part of the Contamination Control Suite (with Environmental Monitoring and Utilities Monitoring) or as a standalone module.
A demonstration is available on request through Novatek's sales team, served from its Montreal headquarters, Paris office, and international partner network.
Novatek markets Nova-CVM as an "off the shelf" solution, evolved through 20+ years of continuous improvement based on user specifications and regulatory requirements. Implementation support is available through Novatek's Montreal headquarters, its Paris office, and a network of international partners.
The vendor states ROI is almost immediate, with time and resource savings compared to manual processes: hours of work accomplished in minutes through automation of worst case determinations and MAC calculations. Implementation timelines, training programmes, and migration support details are undisclosed.
Anonymous feedback from pharmaceutical professionals using this solution
What Users Like
The vendor states automated MAC calculations and worst-case determinations cut cleaning validation work from hours to minutes, and describes the product as the "industry standard" for cleaning validation automation with 20+ years of pharmaceutical industry use. Design follows PDA Technical Reports 29 and 49 and ISPE MaPP. The vendor states paperless workflows reduce human error while maintaining data security and compliance.
What Users Dislike
Only one G2 review exists, limiting independent assessment. Pricing is undisclosed. No customer references or case studies are published. Technical requirements and deployment options are undisclosed.
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