ValGenesis Process Manager

Ensure regulatory compliance and product safety with our purpose-built, risk-based cleaning validation software.

Our application scientifically validates and electronically documents your cleaning process effectively and consistently and reliably removes residues below established acceptance criteria throughout the product lifecycle.

Streamline Compliance and Ensure Product Safety

ValGenesis Process Manager gurantees regulatory compliance and product safety through scientific validation and electronic documentation. Discover the application of the FDA 2011 process lifecycle approach for design, qualification, and monitoring while being guided through the regulatory considerations and best practices for evaluating process or material changes. 

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 with TESCA, SSA, or equipment-specific.

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.

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

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 equipment images

Locate and mark sampling locations on 2D and 3D equipment images.

ValGenesis Process Manager Drives Efficiency Across the Lifecycle

System Controls and Management
Configuration Manager
Master Data Definition
System Administration

Stage 1 Cleaning Process Design

Validation Master Plan
Product Assessments
Cleaning Agent
Cleaning Test
Transfer Stage

Stage 2 Cleaning Process Performance Qualification

Worst Case Product and Equipment Assessment
Residual Limit Calculations
Cleaning Process Step Creation
Risk Management
Validation Protocol Creation (and Execution)
Summary Report
Approved Cleaning SOP
Transfer Stage

Stage 3 Continuous Cleaning Process Monitoring

Standard and Ad Hoc Reports
Process Inventory
Capabilities Part of the Entire Lifecycle
Study Methods
Content Management
Task Dependencies

Learn More From Our Experts

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Blog Post

Product Quality Review (PQR)

Avoiding the Pitfalls of PQRs with Digital Solutions

Read the Blog Post

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Industry Insight

Risk and Data as Knowledge Enablers: A Lifecycle Approach

Read the Article

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CQV: From a Painful Manual Approach to a Smooth Digital Process


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