Validation Accelerator
Digitise the Computer System Validation (CSV) for Pharmaceutical, Life Science and Chemical Industries.
A PwC India Product
A Validation tool to digitise the Computer System Validation (CSV) activities which will enable, enhance, and increase the efficiencies in the CSV process and be audit-ready ensuring compliance. The “Validation Accelerator” tool offers paperless validation, configured form/template-based CSV deliverables creation and easy review/approval, dashboards, one-click data availability, risk assessment, integrated execution & discrepancy reporting, automatic traceability matrix, and digitised vendor assessment.
Challenges
Productivity loss in task tracking
Consolidation of review comments
Reusability of CSV documentation
Inefficiencies in defect tracking and management
Key Benefits for Validation Accelerator
Efficiently prepare and manage deliverables using robust execution, review, and approval workflows, incorporating reusable or cloning script capabilities, automated traceability with summary reporting, and digital vendor assessment and management, all optimised for tablet and mobile device compatibility.
01
Digitised and Automated Process
Prepare and manage deliverables efficiently through robust execution, review and approval workflows,reusable/cloning script capabilities, automated traceability with summary reporting, and digital vendor assessment and management.
02
Task Management
Ensure visibility and monitoring of all assigned tasks, tracking day-by-day progress with execution priority clearly defined.
03
Easy Configuration
Easy setup and configuration of dropdowns, templates, document previews, data export options, risk matrix, project access controls, user access management, and vendor assessment functionalities. Dashboard with project statistics to track, analyse, and monitor the projects and tasks.
04
Tablet and Mobile Device Accessibility
Validation Accelerator is accessible on tablet and mobile devices via Intranet connection.
05
Compliance
Ensure comprehensive oversight and seamless execution with audit trails as per 21 CFR part 11 and EU Annexure 11, contemporaneous execution capabilities, in-built validation checks, live automated traceability, and integrated defect management.
06
Intuitive Interface
Easy and attractive navigation that helps to increase the user adaptability with
minimal training.