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 1. 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. Nova-CVM comprises of unique capabilities and features such as a computerized worst case evaluation. Risk factors including dosage, toxicity, cleanability, solubility and more can be defined together or separately, allowing the user to have complete control over the evaluation settings.