Light Pharma CPV
Digitized Continued Process Verification
Continued Process Verification (CPV) monitors critical process parameters throughout the product lifecycle to ensure manufacturing processes remain in control. Light Pharma CPV digitizes the entire lifecycle with statistical analytics, seamless integration, customizable reporting, and built-in regulatory compliance.
The CPV Challenge
CPV identifies trends, anomalies, and variability to maintain compliance with regulatory standards. However, organizations struggle with managing large datasets and adhering to structured guidelines consistently.
Introducing Light Pharma CPV
A state-of-the-art automation platform designed to digitize the entire CPV lifecycle.
Statistical Analytics
Advanced data analysis capabilities for process monitoring.
Seamless Integration
Connect with LIMS, ERP (SAP, Oracle, etc.), TrackWise, and other systems.
Customizable Reporting
Flexible templates tailored to your needs.
Regulatory Compliance
Built-in adherence to global standards.
Structured Workflow & Collaboration
Development
Create CPV protocols with built-in e-signature support.
Review
Capture comments for transparency across teams.
Approval
Track status visibility and ensure accuracy.
Completion
Achieve timely collaboration and compliance.
Centralized Data Repository
Unified Integration
Light Pharma CPV integrates with key systems to unify data from multiple sources:
- LIMS
- ERP (SAP, Oracle, Microsoft Dynamics)
- TrackWise
- EDMS
Real-Time Visibility
Centralized access enables:
- Batch information and materials tracking
- Analytical methods and process data
- Process deviations and recalls
- Investigations and corrective actions
Smart Scheduling & Tracking
Annual Planning
Schedule CPV protocol creation and re-evaluations.
Periodic Reports
Organize report schedules and addendum creation.
Management Tracking
Generate reports to monitor CPV statuses effectively.
Notifications
Automated emails inform stakeholders of deadlines.
Export options to Word or PDF formats simplify audits and archiving.
Automated CPV Protocol Management
A structured workflow that enables efficient protocol review and execution while maintaining compliance standards.
Data Collection
Gather CPPs and CQAs from manufacturing processes.
Data Analysis
Establish limits using SPC charts and trend analysis.
Re-evaluation
Periodic protocol reviews maintain control standards.
Streamlined CPV Report Generation
Configurable Templates
Support for single or multiple product strengths and markets.
Flexible Import
Import standardized Excel files or enter data manually.
Data Validation
Configurable rules ensure accuracy and consistency.
Export Options
Generate Word or PDF formats for audits and archiving.
Robust Role Management
Role-Based Access Control
Light Pharma CPV enables secure operations through precise privilege assignment:
- View, edit, approve, or export permissions
- Clear accountability across teams
- Minimized user errors
- Restricted access to sensitive data
AI-Augmented Summaries
Automated Intelligence
Generative AI creates summaries and recommendations based on CPV data.
User Control
Override AI-generated content as desired to maintain accuracy.
Data Security & Regulatory Compliance
Audit Trails
Secure tracking of all changes and approvals for complete transparency.
E-Signatures
Embedded digital signatures ensure data integrity and authenticity.
Global Standards
Compliant with CGMP, 21 CFR Part 11, and EU Annex 11 regulations.
Inspection Ready
Exportable change histories prepared for regulatory inspections.
Light Pharma CPV In Action
See how Light Pharma CPV transforms Continued Process Verification - from centralized data and automated protocols to AI-augmented reporting.
Centralized Data Repository
Real-time visibility into batches, materials, analytical methods, deviations, and corrective actions - across LIMS, ERP, TrackWise, and EDMS.
Automated CPV Protocol Management
Gather CPPs and CQAs from manufacturing, establish limits using SPC and trend analysis, and run periodic re-evaluations to maintain control.
Streamlined Report Generation
Configurable templates, flexible Excel import, configurable validation rules, and one-click export to Word or PDF for audits and archiving.
AI-Augmented Summaries
Generative AI creates summaries and recommendations from CPV data - quality professionals review and override every output to maintain accuracy.
The Light Pharma CPV Advantage
Minimize Manual Effort
Reduce errors through automation and streamlined workflows.
Enhance Capability
Improve process and product quality with advanced analytics.
Regulatory Readiness
Maintain compliance with embedded regulatory features.
Frequently Asked Questions
What is Continued Process Verification (CPV)?
CPV is Stage 3 of process validation (per FDA Process Validation Guidance and EMA Annex 15). It is the ongoing assurance during routine production that the process remains in a state of control. CPV monitors critical process parameters (CPPs) and critical quality attributes (CQAs) using statistical tools throughout the product lifecycle.
How does Light Pharma CPV streamline protocol management?
Annual planning for protocol creation and re-evaluation, periodic report schedules, addendum creation, management tracking dashboards, and automated notifications - with one-click export to Word or PDF for audits.
What statistical capabilities does it provide?
Cpk/Ppk capability metrics, SPC control charts with trend analysis, X-bar/R charts, histograms, and capability analysis graphs for ongoing evaluation of newly manufactured batches.
Which systems does it integrate with?
LIMS for laboratory data, ERP (SAP, Oracle, Microsoft Dynamics) for enterprise data, TrackWise for quality events, EDMS for documents, plus standardized Excel imports where direct integration is not available.
How does the AI work?
Generative AI creates summaries and recommendations from CPV data. Quality professionals retain full editorial control - every AI output can be overridden, and a complete audit trail captures every change.
Is it 21 CFR Part 11 and EU Annex 11 compliant?
Yes. Audit trails, embedded e-signatures, role-based access controls, exportable change histories for inspection, and compliance with CGMP, 21 CFR Part 11, and EU Annex 11.
Ready to See It in Action?
Book a 30-minute live demo. We will walk through your data, your workflow, and your compliance requirements - whatever matters most to your team.
Or copy our address: support@lightpharma.com · we usually reply within one business day.