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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
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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
Computerized Risk-Based Worst-Case Evaluation
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.
Fully Automated MAC Calculations
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.
System Defined Protocol
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.
Dedicated Risk Control Feature
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.
Process Dedicated Change Evaluation
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.
Pros And Cons of Nova-Cleaning Validation
Pros
Automates complex calculations instantly
Achieves complete contamination control
Fully paperless system reduces manual errors.
Cons
Integration often requires third‑party API connections
Might require initial training for better software adoption
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Frequently Asked Questions
Does Nova-Cleaning Validation have a mobile app?
No, Nova-Cleaning Validation does not offer a dedicated app.
What other apps does Nova-Cleaning Validation integrate with?
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 and Oracle.
What language does Nova-Cleaning Validation support?
Nova-Cleaning Validation software primarily supports English Language.
Who are the typical users of Nova-Cleaning Validation?
The typical users are in pharmaceutical manufacturing, biotech manufacturing, life sciences, and other healthcare industries.
Does Nova-Cleaning Validation offer an API?
No, Nova-Cleaning Validation does not offer an API.
What level of support does Nova-Cleaning Validation offer?
Nova-Cleaning Validation offers support via email, phone, and online submission form.
What types of pricing plans does Nova-Cleaning Validation offer?
The Nova-Cleaning Validation pricing is customized according to the specific business requirements. Get a detailed Nova-Cleaning Validation cost breakdown tailored to your specific requirements.