Enabling Organizations to Transition to a Digital QMS for Increasing Quality, Compliance and Productivity
Quality Management is increasingly getting complicated move away from traditional paper-based Quality Management System (QMS) to a sophisticated Digital QMS platform. This transition is not a straightforward change as it requires a well-planned collaborative transition effort from all stakeholders across Quality, IT, and Business Process functions.
Sparta Systems, a Honeywell Company, is a pioneer in providing next-generation enterprise and cloud-based QMS software solutions to regulated industries to establish proactive quality management processes while minimizing product risks and ensuring regulatory compliance.
As a channel partner of Sparta Systems, Techsol specializes in providing technology and process consulting expertise to get the maximum value from the TrackWise® Quality Management System (QMS) for Pharma, Biopharma, Life Sciences and Medical Device companies.
Using the GAMP 5 Risk-based validation methodology, we have developed TrackWise implementation accelerators that reduces overall duration and eliminating manual errors during the setup, validation, and system rollout. Following are our key strengths to deliver value for our clients:
Manikanda Poopathy, Head of Quality Technology
Our TrackWise EQMS Services
Strategic QMS Technology Consulting
Our team of Subject Matter Experts can provide strategic guidance for:
- Performing System Selection (TrackWise Digital / TrackWise On-premise / Hybrid model)
- Completing QMS Requirements Fit-Gap Analysis
- Defining a cost-effective TrackWise Technology Stack
- Identifying Use Cases and laying out the QMS implementation roadmap
- Documenting Digital Quality Management Process Requirements
- Preparing TrackWise system implementation and validation plan
- Defining TrackWise System Integration Design for Quality Processes
- Identifying KPIs for Quality Metrics
TrackWise Digital Demo
TrackWise EQMS Implementation / Upgrade / Migration & Validation
Our team of Subject Matter Experts can provide strategic guidance right from gathering system requirements, defining TrackWise technology roadmap, to incremental digitalization of quality processes. We can also help your quality team to successfully migrate from a manual paper-based QMS or from another digital QMS to TrackWise.
Our key validation deliverables and activities for TrackWise implementation includes:
- Validation Plan
- Functional Requirement Specification
- Functional Risk Assessment
- TrackWise Installation Qualification (IQ) Protocol and Scripts
- Execution and documentation of Installation Qualification (IQ)
- Configuration Requirements Document
- Configuration & Customization of TrackWise extended features
- Operational Qualification (OQ) Protocol and Scripts
- Execution and Documentation of Operational Qualification (OQ)
- Requirement Traceability Matrix
- Performance Qualification (PQ) / UAT Scripts
- Validation Summary Report
To ensure a succesful TrackWise EQMS software implementation, it is very important to define the ‘As-is’ and ‘To-be’ quality processes. As part of this requirements definition, you need TrackWise SMEs who can document configuration specifications, master lists, and digital process workflows.
To save time, its important to use a requirements and configurations management utility to quickly setup the TrackWise EQMS to avoid manual errors. To minimize the time and effort for validation of TrackWise, you need SMEs who are well-versed in drafting test scripts in pre-defined templates to test your organization specific quality process workflows.
End-user training and having continous support for business users is crucial while your organization is in the process of adopting the TrackWise EQMS.
Yes, Techsol offers SLA-based TrackWise application support services to address user requests, address reported incidents, and facilitate ongoing change management.