The competitive landscape and fast-paced direction of the Pharma and Life Sciences industry demands organizations to 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.

Techsol has helped companies to not only select the right technology vendor but also worked as an extended partner to implement and validate different types of QMS platforms. Our team's knowledge on global and regional regulations can be leveraged to successfully implement, configure and validate the QMS platform to account for regulatory compliance (ISO 13485 Standard, FDA’s 21 CFR Part 11, ICH’s GxPs etc.)

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 MetTech 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

Techsol QMS Solutions

QMS Modules

Our team of subject matter experts can provide knowledge support for selecting, configuring and implementing the right solution choice for:

  • Quality Management Process Oversight
  • Document Management
  • Product Complaints Management
  • Training Management
  • Integrated Risk Management
  • Supplier Quality Management
  • Audits Preparation
  • Quality Metrics & Reports

With our technology and validation expertise, we have helped clients to derive maximum value from their QMS platforms through external system integrations, advanced analytics and insights generation.

Are you planning to implement a next-generation, Digital QMS Platform that given 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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