What Makes Paper-based Process Validation So Challenging?
Benefits of Digitizing Your Process Validation Efforts
Complete, compliant system: ValGenesis offers users a lifecycle approach to process validation in compliance with 21 CFR Part 11, Annex 11 and ALCOA data integrity principles. The solution also complies with the FDA Guidance for Industry: Process Validation: General Principles and Practices (2011) and enables cGMP regulations for validating pharmaceutical (drug) manufacturing processes to meet all the attributes they are intended to possess: 21 CFR 211.100(a) and 211.110(a).
Holistic validation management: The solution is tightly coupled with other ValGenesis solutions, including analytical method validation, cleaning validation, and equipment and instrument validation, for a holistic approach to validation management.
Risk-based approach: Using risk assessment models, our VLMS helps you conduct a risk assessment and mitigation plan for process design, parameters and attributes (e.g., CMA, CPP and CQA). The risk assessment approach is also used to identify the number of batches to be taken as part of process performance qualification (PPQ) with required justification and approvals.
Increased data integrity: Our VLMS dynamically collects the critical control points (CCPs), as per the predefined schedules, and updates batch records to eliminate human error and provide a higher degree of data integrity.
100% paperless: With ValGenesis, all validation deliverables are created, reviewed and approved electronically, entirely eliminating paper from the validation process.
Process validation master plan: Our process validation master plan drives all stages of process validation and enforces the required studies and deliverables at every stage with required dependencies between studies and deliverables.
Improve Process Validation with These Unique Features
With ValGenesis VLMS maintaining your organization's process validation efforts, you'll enjoy a host of robust features and functions, including:
- Assessments powered by decision-tree logic
- Real-time information on the validation status of your products
- Applied critical thinking with procedural risk assessments at system and functional requirements levels
- Automatic task notification, schedules, and nudging features with email
- Integrated close-looped process validation lifecycle management
- Controlled template management and approval
- Workflow management
- Automated trace matrix generation
- Real-time collaboration with remote and distributed teams
- 21 CFR Part 11-compliant features like time-stamped audit trails, reporting, and electronic signature capabilities
Ready to join the digital validation revolution?
"We reduced cycle time more than 50% and gained data integrity in our validation process."
"Validation-related observations dropped 90% after implementation."
"We can easily manage validation deliverables and change requests across global sites with full data integrity."