TrackWise Quality Processes

Accelerate Your Quality Management Processes
to the Next Level

Today’s companies in the life sciences industry are facing increasing compliance pressures than ever before, to meet and maintain the highest quality standards in order to stand up to inspections and scrutiny from both customers and regulatory bodies. Any undesirable audit result can directly affect the company’s profitability.

Driven by regulatory pressures and the constant need to streamline processes, reduce costs and protect brand reputation, life sciences companies are prioritizing EQMS as one of their top initiatives for IT enterprise solutions roll-out.

A scalable, flexible and reliable quality management system is paramount to the success of every life science company today to achieve their quality vision and to ensure future business sustainability.

Audit Management

The TrackWise Audit Management solution empowers companies to manage the full life-cycle of audits while helping to ensure that findings and observations are resolved in a timely and effective manner. TrackWise assists auditors to plan and execute audits more efficiently by providing an integrated tracking system and powerful workflow engine that automates all steps in the audit lifecycle including: scheduling, preparation, auditing, report approval, report issuance, response and corrective action tracking. TrackWise enables your organization to take a best practices approach to compliance and risk management and support all audit programs and activities using an enterprise market-proven solution.

CAPA

Corrective and Preventive Actions (CAPA) is essential to ensuring a closed-loop quality management process ranging from quality events, complaints, audits and so on. TrackWise CAPA solution captures all the related CAPA information using user-definable fields and forms with auto-creation of effectiveness checks for future reviews. Automatic notifications can be sent ensuring nothing falls through the cracks while complying with regulatory standards throughout the entire CAPA process.

Change Control

Change control systems must ensure there are consistent procedures in place to drive informed decision-making by qualified individuals and those decisions can be traced back to the justifications behind the changed processes. TrackWise Change Control solution enables companies to improve efficiency, increase control, and reduce defects by implementing a cohesive change control program that integrates with other components of the quality management system. TrackWise is designed to be flexible enough to manage all types of change using one centralized solution including equipment change, material change, product change and others.

Complaint Management

In any company, the key to maintaining customer retention, compliance with industry regulations and avoidance of potential product liabilities are the three cornerstones of an effective complaint management system. TrackWise Complaint Management solution can effectively log, track, respond, investigate and resolve customer complaints. Complaints are entered or captured into TrackWise which automatically creates investigation tasks and assigns them to the relevant individuals/groups. Protect brand reputation and increase customer satisfaction by ensuring that complaints are investigated and responded to in a timely manner.

Regulatory Compliance

TrackWise is the foundational element for regulatory compliance. Being 21 CFR Part 11 compliant and fully supporting similar regulations around the world including EU Annex 11, GxP Regulations, GAMP, ISO, etc, TrackWise is the gold standard EQMS widely recognized by global regulatory bodies. TrackWise optimizes the overall value chain by consolidating company-wide quality processes and standardizing workflows, which in turn helps Management executives make better business decisions based on real-time and factual quality data.

  • Deviation Management
  • Complaint Management
  • CAPA
  • Change Control
  • Audit Management
  • Effectiveness Check
  • Correction
  • Investigation
  • Planned Deviation
  • Quality Assessment
  • Due Date Extension
  • Out of Specification (OOS)
  • GMP Incident
  • Temporary Change Control
  • Training Management
  • Root Cause Analysis
  • And Many More