Pharmaceuticals and Medical Devices are organizations in highly regulated industries and thereby continue to face pressure to maintain the high degree of quality in every facet of their operations. Various stakeholders such as international regulatory authorities, global customers and other key stakeholders mandate stringent quality management processes. Hence these organizations, in order to maintain top level of quality, needs to implement robust Quality Management Processes. Hence, the need to have best-in-class quality management system in place is crucial to an organization. Compliance to regulatory norms and adoption of key stakeholders from user community is critical for the success of these systems. Hence it is most important to have a blend of domain and technical skill to implement these systems.

Why Quality Management Systems?

  • Increased scrutiny of quality due to high visibility quality complaints and adverse events
  • Ensuring regulatory compliance as per the requirement of different agencies
  • Reduce costs through improvement of quality
  • Integration of suppliers in the quality management processes

How Can Navitas Life Sciences Help?

Navitas Life Sciences has helped organizations strategize and implement Quality Management Systems as well as providing robust support for these systems. We are one of the key partners of Sparta Systems in the quality management space. We have a strong team highly experienced the enterprise quality management processes such as Deviations, CAPA, Change Control, Audit Management, Out Of Specifications/Out Of Trends, Supplier Quality Management, Complaint Handling etc.

Navitas Life Sciences qualityREADY is a proprietary framework designed for enabling rapid deployment of TrackWise EQMS Application. This framework ensures high quality regulatory compliant deployment within a short timeframe. This framework comprises of accelerators for Process Design, Configuration, Validation, Data Migration and Training.

Offerings

  • Implementation
  • Reports, Integrations, Configurations & Enhancements
  • Upgrade & Migration
  • Training

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