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Overview
Nova-Cleaning Validation is a specialized manufacturing software that manages validation and risk. Though the support may vary at times, it offers fully automated Maximum Allowable Carryover (MAC) calculations that significantly reduce human error and save time. Overall, Nova-Cleaning Validation's automated benefits make it a compelling choice for contamination control.
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Starting Price
Custom
Nova-Cleaning Validation Specifications
Quality Control
Compliance Management
Document Management
Reporting And Analytics
What Is Nova-Cleaning Validation?
Nova-Cleaning Validation serves as a cutting-edge contamination control platform, purpose-built to automate and accelerate cleaning validation and risk management processes. It offers unique features like system-defined protocols and comprehensive reporting to significantly enhance product integrity. The software is ideal for life science manufacturers, especially those in the pharmaceutical and biotech industries, who need to efficiently reduce the risk of cross-contamination, ensuring complete regulatory adherence, and achieving a total state of control.
Nova-Cleaning Validation Pricing
Nova-Cleaning Validation Integrations
Novatek integrates with critical third-party software systems, including Enterprise Resource Planning (ERP), Manufacturing monitoring Instrumentation, and Laboratory Information Management Systems (LIMS), such as:
- SAP
- Oracle
Who Is Nova-Cleaning Validation For?
Nova-Cleaning Validation software is ideal for a wide range of industries and sectors, including:
- Pharmaceutical manufacturing
- Biotech manufacturing
- Life sciences
- Healthcare industries
Is Nova-Cleaning Validation Right For You?
Nova-Cleaning Validation is a vital tool for organizations needing to enforce strict regulatory compliance, specifically 21 CFR Part 11 and EU Annex 11. The system is meticulously designed based on PDA Technical Reports 29 and 49, making it an authoritative solution for quality assurance. Its unique process-dedicated change evaluation feature provides a single, instant snapshot of risks resulting from multiple process changes, enabling proactive decision-making. If your goal is to transition from manual, error-prone processes to automated, audit-ready compliance, this software is the best fit.
Still doubtful if Nova-Cleaning Validation is the right fit for you? Contact our customer support staff at (661) 384-7070 for further guidance.
Nova-Cleaning Validation Features
The system allows users to define and control various risk factors, including toxicity, dosage, and solubility, either together or separately. This feature automatically determines and highlights the worst-case scenario across all validation groups, enabling teams to prioritize and mitigate the most significant risks to product quality effectively.
The software executes hundreds of Maximum Allowable Carryover (MAC) formulas within seconds, a task that typically consumes hours when performed manually. It automatically accounts for all possible product A and product B combinations for affected equipment, clearly displaying the lowest MAC values for quick and confident user review.
Sampling plans are automatically generated for all validation groups, deriving details from pre-defined sample points, MAC limits, and analytical methods. This automated process ensures that protocols are standardized and accurate, allowing users to efficiently schedule both validation events and interim monitoring based on approved, compliant procedures.
This functionality offers a holistic, process-specific approach to risk mitigation by actively managing changes in a dynamic production setting. It automatically evaluates modifications to cleaning methods, APIs, and equipment families, ensuring continuous product integrity and immediate adherence to all current regulatory requirements.
This unique feature consolidates the impact of multiple simultaneous changes into a single, comprehensive snapshot. It assesses risks and consequences related to adjustments in equipment, new product introductions, or modified batch sizes, providing an immediate and clear overview of how these factors affect the validated state of the cleaning process.
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