Driving compliance and efficiency through Digital Transformation
Epiqure provides end-to-end support for the implementation, validation, and optimization of electronic systems within regulated environments. Our experts help organizations seamlessly adopt technology solutions that enhance compliance, data integrity and operational excellence across all GxP domains.
Computerised System Validation (CSV)
We deliver full computerised system validation support, from planning and documentation to testing and reporting, ensuring every system meets regulatory expectations and performs as intended.
Key Benefits
- Compliance with GxP and data integrity regulations
- End-to-end validation lifecycle management
- Reduced project risk through structured methodology
- Expert documentation and audit readiness
Our Validation Expertise Includes:
- High-Level Risk Assessment
- Validation Plan (VP)
- User Requirements Specification (URS)
- Functional, Technical, or Design Specifications
- Requirement Risk Assessment (RRA)
- IQ, OQ & PQ Protocols and Execution
- Traceability Matrix and Master Index
- Validation Report Compilation
- Review or Update of Vendor Deliverables
- Support in or execution of test activities
Business Transformation
We guide clients through the successful integration of electronic systems into their existing processes and governance models. Our experts ensure that every implementation aligns with both regulatory and business requirements.
Key Benefits
- Smooth adoption of new systems
- Optimized process alignment and workflow integration
- Improved data traceability and efficiency
- Sustained compliance through organizational readiness
Our Validation Expertise Includes:
- Assessing and leading optimal system implementation approaches
- Integration design and coordination with other systems
- Identification and update of impacted SOPs and Work Instructions
- Delivery of training and knowledge transfer
Project & Program Management
Our experienced project managers oversee the entire lifecycle of system implementation and validation projects, ensuring efficiency, communication, and accountability at every stage.
Key Benefits
- Clear visibility and control over project milestones
- Efficient coordination across teams and vendors
- Timely delivery within regulatory and quality frameworks
- Transparent governance and risk management
Our Support Includes:
- Project Charter & Governance Structure
- Project Planning and Gantt Chart Development
- Meeting Coordination and Stakeholder Alignment
- Governance, Escalation, and Communication Management