Critical Efficiencies Gained from Digitizing the Cleaning Validation Lifecycle
Globally Harmonized Validation Program
Adhere to FDA 2011 process lifecycle approach for design, qualification, and continued monitoring with a comprehensive end-to-end digital platform.
Automated Documentation System
Minimize errors with an automated documentation system equipped with configurable templates for cleaning validation master plans, SOPs, cleaning tests, validation protocols, and more.
Streamlined Change Assessment
Leverage comprehensive frameworks that guide you through regulatory considerations and best practices for evaluating the impact of process or material changes.
Optimized Equipment Design Process
Implement a risk-based approach for contact parts, using 2D or 3D imaging to identify sampling locations, then associate cleaning tests with equipment design.
Establish a Plan
Systematically incorporate all variables into your overall validation master plan
- Include equipment and product vendor data in your models
- Get clear and precise residual limits based on a variety of configured criteria from integrated analytical methods
- Auto-calculate contact surface areas using shared surface area (SSA), total equipment surface contact area (TESCA), or equipment-specific modes
- Confidently determine analytically supported acceptance criteria
- Establish equipment and product groups for worst-case analysis
Calculate shared surface areas in three modes: TESCA, SSA, or equipment-specific.
Assess and Mitigate Risk
Streamline and optimize your cleaning process with an advanced risk management system
- Utilize prebuilt or custom risk models to determine appropriate risk levels, define failure modes, and create effective mitigation plans at every step of the process (all based on ICH Q9 principles for risk management)
- Reduce cross-contamination and ensure product safety with equipment design that incorporates risk assessment at each contact part level
- Determine sampling locations from risk assessments
- Systematically define failure modes and create mitigation plans
Assess risk at each step in the cleaning process.
Produce Scientifically Sound Results
Follow your scientific plan with frameworks, documents, and workflows
- Configure the unit of measure and critical cleaning process parameters
- Set acceptance criteria by comparing LOD and LOQ values for precise residual limits
- Perform residual limit calculations based on various criteria, including 10 PPM, HBEL, dose-based, toxicity-based, and more
- Employ our intelligent transfer stage gatekeeper to ensure each stage's tasks are completed
Automatically calculate residual calculations with criteria such as 10 PPM, HBEL, dose-based, and toxicity-based.
Monitor and Improve
Gain unparalleled system awareness
- Create dashboards for instant access to analytics at the global, site, group, product, or equipment level
- Schedule periodic reviews to monitor and maintain the health of your cleaning program
- Establish alert and action limits to notify the team of any out-of-specification (OOS) deviations
Locate and mark sampling locations on 2D and 3D equipment images.
Explore Solutions for Process Manager
Learn More From Our Experts
Blog Post
Computer System Validation (CSV)
Leveraging Vendor Testing: A Smarter Approach to Validation
See how ValGenesis can support your digital transformation.