Sparta Systems, a Honeywell Company

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Our Synergy with Sparta Systems

Sparta Systems, a Honeywell Company, brings leading-edge quality management solutions to regulated industries. With nearly three decades of experience, Sparta provides enterprise and cloud-based QMS software solutions that help companies go to market faster while minimizing product risks and ensuring compliance. Sparta is an innovator in its field and is driving smart quality with first-of-its-kind AI-enabled quality solutions.

Core Quality Processes

QUALITY EVENTS

Digitize and connect quality events to quickly act on issues.

NONCONFORMANCE AND OUT OF SPECIFICATION

Manage and trend nonconforming product, investigations and approval of resulting actions and product dispositions.

DEVIATIONS

Manage deviations in a centralized location, with associated investigations, approvals and resulting records.

CORRECTIVE AND PREVENTIVE ACTIONS

Fully integrated CAPA system with automated routing, notification, delivery, escalation and approval capabilities.​

AUDIT MANAGEMENT

An integrated tracking and workflow engine that automates audit findings, responses, corrective actions, approval and reporting.

CHANGE CONTROL

Manage changes from request, through pre-approvals, change execution, follow-up approvals and implementation.

DOCUMENT AND TRAINING MANAGEMENT

Manage quality content throughout the value chain and automate company-wide training policies and regulatory requirements.

COMPLAINT HANDLING

Manage the entire complaint lifecycle, from investigation to resolution, and gain insights for continuous improvement.

PRODUCT REGISTRATION TRACKING

Significantly reduce the time, cost and resources needed to track product submissions with regulatory agencies around the globe.

Techsol's Specialized Services Offered for TrackWise® QMS

As a channel partner of Sparta Systems, a Honeywell Company, we specialize in providing managed technology services and process consulting expertise to implement, upgrade and support the TrackWise® Quality Management System (QMS) for Pharma, Biopharma, Life Sciences and Medical Device companies.

Team Discussion

How We Help Clients

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) and completing client QMS Requirements Fit-Gap Analysis
  • Defining TrackWise Technology Stack
  • Identifying Use Cases and laying out the QMS implementation roadmap
  • Documenting Functional Requirements Specification
  • Preparing TrackWise system implementation and validation plan
  • Providing knowledge support for selecting, implementing and configuring the right solution choice based on industry best practices for Quality Processes such as:
    • Deviation Management
    • Root Cause Investigation
    • Corrective and Preventive Actions
    • Change Management
    • Risk Assessment
    • Out Of Specification and Out of Trend (OOS / OOT)
    • Complaints Management
    • Document Management
    • Audit Management
    • Training Management
    • Vendor / Supplier Quality Management
  • Defining TrackWise System Integration Design for Quality Processes with:
    • Enterprise Resource Planning (ERP) Systems
    • Customer Relationship Management (CRM) Applications
    • Laboratory Information Management Systems (LIMS)
    • Product Lifecycle Management (PLM) Systems
    • Manufacturing Execution Systems (MES)
    • Learning Management Systems (LMS)
    • Document Management Systems (DMS)
  • Identifying KPIs for Quality Metrics

CSM Coding

TrackWise System Implementation / Upgrade / Migration & Validation

Using the GAMP 5 Risk-based validation methodology, we have developed TrackWise implementation accelerators that reduces overall effort for completing setup, validation, and  system rollout. 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

TrackWise Upgrade Services:

  • We perform TrackWise upgrade from 8.x to 10.x or 9.x to 10.x
  • Help clients to move from TrackWise On-premise to TrackWise Digital
  • Define TrackWise System Upgrade and Validation Plan
  • Perform Functional Risk and Impact Assessment for Retired and New Features
  • Designing of Intelligent Forms and implementation
  • Execute upgrade related IQ/OQ validation activities and generate relevant documentation

Quality management

Post-Implementation Configurations Management & Application Support

We offer SLA-based TrackWise application support through our Service Desk across time zones. This includes:

  • Handling user requests (Application help, Password reset, Configuration Change, etc.)
  • Performing user access management (Login and Person Account Creation,  Roles & Permissions access management, Deactivation, etc.)
  • PR Import (Due Date Update, Person Name Update and PR State Update)
  • Performing RCI, Impact Assessment and CAPA
  • Application / Database Performance monitoring and tuning
  • Liaising between Client and Sparta for any product related support
  • Addressing new TrackWise configuration requirements under Change Management

Techsol MedTech FSCA

Other Value-focused TrackWise Services

If you are planning to move away from another QMS to TrackWise, our team can provide both process and technology consulting services for:

  • Source Data Migration & Testing
  • Establishing System Integrations with TrackWise
  • Developing new reports and dashboards to provide insights on QMS processes

Are you planning to implement a next-generation, Digital QMS Platform that gives you the power of establishing proactive Quality Management with advanced analytics and artificial intelligence?

Get in Touch With Us and We Will Help You Get Started.

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