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.)

Team Discussion

Our Trackwise QMS Consulting Practice

Strategic Consulting

Our team of Trackwise Digital QMS Subject Matter Experts can provide strategic guidance with best-practice frameworks to complete:

  • Performing System Selection and Fit-Gap Analysis
  • Defining QMS Technology Roadmap
  • Identifying Use Cases
  • Documenting System Requirements Specification
  • Preparing Trackwise system implementation plan

QMS System Implementation & 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 for Trackwise implementation includes:

  • System Requirements Specification, Risk Management Report, Validation Master Plan
  • IQ/ OQ Test Scripts and Reports, Requirements Traceability Matrix and Validation Summary Report

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 (Roles, permissions, access grant / revoke, etc.)
  • Resolving incidents by working with Sparta product management group
  • Addressing new Trackwise configuration requirements
  • Facilitating IT  change management

Trackwise Hosting, Data Migration & Application Upgrade

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

  • Fully-managed Trackwise hosting on Techsol Cloud
  • Source Data Migration & Testing
  • Performing Application Upgrades
  • 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?

Latest Insights

4 Effective Strategies to Accelerate Site Selection to Activation

Introduction to the site selection process Clinical research organizations (CRO) predominantly rely on the internal networks and investigator database to support a clinical study for a drug. As the clinical sphere continues to expand at a rapid pace, there is an upsurge in demand for clinical trial sites worldwide. CROs are striving for new sites […]

Aggregate Reporting – Significance, Classification and Challenges

Aggregate reports are the cumulative reports in the database that emphasise on evaluation of safety profile and risk-benefit analysis of a drug. Aggregate reporting is the process of compilation and submission of aggregate reports to the regulatory agencies over the period of the product’s life cycle (during pre-marketing and post-marketing phase) to provide a comprehensive [...]

Literature Screening – Process overview, challenges en-route and the scope for automation

Medical and scientific literature is a valuable source of safety information that helps in monitoring benefit-risk profiles and emerging safety issues of medicinal products. Literature screening is conducted to ascertain abstracts and articles that provide crucial information on serious and non-serious Individual Case Safety Reports (ICSR) reports and risk-benefit assessment of a drug. The scientific […]

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