VxP Validation Platform

VxP Validation Platform is a cloud-based software solution developed by DHC Business Solutions for automating validation processes and managing validation documentation digitally. It is designed specifically for highly regulated industries, including pharmaceutical, chemical, and life sciences companies operating under GxP requirements. The platform is pre-validated and available immediately after registration, requiring no implementation project, installation, or initial training.

Traditional validation processes are document-intensive and largely paper-based, creating risks around data integrity, incomplete signatures, incorrect document IDs, missing audit trails, and outdated templates. VxP addresses these challenges by providing a fully digital, paperless environment where all validation activities can be performed remotely and on mobile devices. The platform follows the V-model methodology in accordance with GAMP® and complies with GxP guidelines, FDA, EMA, PIC/S, ICH requirements, and 21 CFR Part 11.

Validation Document Management

• Template-based support for planning, definition, specification, risk analysis, test planning, test execution, and reporting
• Integration with MS Office
• Audit-proof storage and management of validation documents
• Status management and versioning
• Complete version history and audit trail
• Workflows for document creation, review, and approval processes
• Real-time publication of validation documents with automatic conversion to PDF
• Notification, reminder, and escalation mechanisms
• Controlled printouts and authorised paper copies

Maintaining the Validated State

• End-to-end process support across the full system lifecycle
• Best practice workflows for managing deviations, CAPAs, and changes
• Intuitive data entry via web dialog
• User-centric task dialogs, input masks, and forms
• Integrated linking of validation documents
• Flexible catalogue management for errors, root causes, CAPAs, and related items
• Reminder and escalation mechanisms
• Controlled printouts and authorised paper copies

Analytics and Traceability

• High-performance cognitive search including full-text search
• Extensive status tracking mechanisms and traceability reports
• Point-in-time analyses of validation documentation and ongoing processes
• Detailed reports with visualisation for identifying trends, risks, opportunities, and frequencies
• System-supported monitoring of deadlines and document validity
• Role-specific dashboards displaying aggregated key figures and relevant information
• Display of all validation documents by current status

Included Document Templates

• Validation Report, User Requirements Specification (URS), Functional Specification (FS)
• Risk Analysis (RA), Part 11 Analysis, Design Specification (DS)
• Installation Qualification Plan and Report (IQ)
• Operational Qualification Plan, Test Case, and Protocol (OQ)
• Performance Qualification Plan, Test Case, and Protocol (PQ)
• Standard Operating Procedures (SOPs)

Document Management System (DMS) Capabilities

• Audit-proof management of all validation documents
• Workflow engine with electronic signature support compliant with 21 CFR Part 11
• Systematic procedures for invalidation, validity extension, reactivation, archiving, and controlled printing
• Export of all documents in MS Office and PDF formats, with no vendor lock-in

Deployment and Scalability

• Available immediately after registration with no implementation project required
• No installation, integration, or formal training needed; eTutorials and quick guides are included
• Multisite concept supports rollout across departments, locations, countries, or the entire organisation
• Scales dynamically to serve as a central platform for all global validation activities
• Customer-specific validation documents can be created within the platform on request

Compliance and Validation Package

• Complies with GxP guidelines and regulations from FDA, EMA, PIC/S, and ICH
• Conforms to 21 CFR Part 11 for electronic records and signatures
• Includes a Validation Package consisting of Validation Accelerators (a complete documentation set for system validation) and Validation Services for adapting documentation to individual customer requirements
• Each module includes User Requirement Specification, Functional Specification, Operational Qualification, and Risk Analysis documentation

VxP Validation Platform is part of the broader DHC VISION product suite, which also includes modules for training management, CAPA, deviations, complaints, change control, and audits. The platform is offered as a cloud-based SaaS solution and is positioned for use across pharmaceutical, chemical, and other highly regulated life sciences environments.