Key Features
Risk-Based Validation Approach
Novatek employs a structured risk assessment framework to prioritize cleaning validation efforts based on the potential impact residues may have on product quality and patient safety.
Standard Operating Procedures (SOPs)
The solution provides clearly defined and detailed SOPs for cleaning procedures, ensuring consistency, reliability, and repeatability across validation processes.
Robust Analytical Testing Methods
Novatek utilizes advanced analytical techniques—including HPLC, UV-Vis spectroscopy, and precise surface sampling—to accurately quantify residues and validate cleaning efficacy.
Comprehensive Documentation and Reporting
The system offers powerful documentation and reporting capabilities to streamline regulatory submissions, maintain detailed validation records, and demonstrate ongoing compliance.
Personnel Training and Ongoing Support
Integrated training modules ensure personnel are fully educated on cleaning validation protocols, promoting compliance, knowledge retention, and organizational readiness.
Automated Workflow Management
Automated data collection and analysis tools enhance operational efficiency, streamline the validation process, and significantly reduce risks associated with manual errors.
Why choose Cleaning Validation?
Rapid ROI Through Time Savings
The automated and streamlined nature of the system delivers significant time savings over traditional manual processes, accelerating return on investment.
Enhanced Data Security and Compliance
Fully compliant with FDA 21 CFR Part 11, the solution provides robust data integrity, secure electronic records, and comprehensive audit trails.
Reduced Errors Through Digitization
By eliminating paper-based records, Novatek minimizes human error, ensuring accurate data capture, secure data management, and improved compliance.
Efficiency with Electronic Master Data Management
Digitally manages and approves master data, reducing the complexity and administrative burden associated with traditional processes.
Automated Protocols and Sampling Plans
Automatically generates system-defined protocols and sampling plans tailored to specific validation requirements, increasing consistency and accuracy.
Advanced Reporting and Analysis
Comprehensive reporting features enable users to quickly generate detailed standard reports and perform statistical analyses, facilitating informed, data-driven decisions.