With increasing regulatory expectations and ever greater scrutiny Life Sciences face significant pressure to maintain the high degree of quality in every aspect of their operations. These organizations, in order to maintain top level of quality, need to design and implement robust Quality Management Processes covering key areas such as Deviations, CAPA, Change Control, Audit Management, Out Of Specifications/Out Of Trends, Supplier Quality Management, Complaint Handling etc. Getting this right delivers a number of critical benefits.

Why Quality Management Processes Important?

  • Alignment of quality management initiatives with business goals
  • Implementation of best practice business processes for managing quality – efficiency and effectiveness
  • Sets clear direction and defines requirements for IT investments and support

How Can Navitas Life Sciences Help?

Navitas, with its strong domain expertise in quality management processes and has deep understanding of industry requirements.

  • As is business process understanding and analysis
  • Identification of quality process issues and regulatory compliance issues
  • Development quality management processes and strategy roadmap
  • Detailed QM process design and implementation

Offerings

  • Quality Management Strategy & Roadmap
  • Quality Management Process Re-engineering
  • User requirement specification and system selection support

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