Integrated approach of analytics, technology, Six Sigma methodologies, medical and pharma expertise used in the phases of development, manufacturing, and quality.


A robust quality management system in the pharmaceutical industry (21 CFR Part 211 for companies under FDA and Article 6 of Directive 2003/94/EC and Directive 91/412/EEC for companies under EMA) is considered as a basic requirement and a critical element of regulatory compliance. Indegene offerings are coupled with AI and NLP techniques in delivering process performance and product quality monitoring system, CAPA system, change management system, and management review of process performance and product quality as a part of ICH Q10. We have a pioneering delivery of innovative solutions like automation of triaging of complaints (AE vs MI vs PQC) and workflow management. We also provide a platform that leverages current QMS data to create deep insights and visibility into quality information. Combined with our business process capabilities to handle complaints, CAPA, NC, Hazard Analysis and Risk management, our automation capabilities and analytics enables setup of a modern efficient quality operations driven by automation and insight generation.


  • Audit Management
  • Document Management
  • CAPA Management
  • Non-conformance
  • Change Management
  • Recall Management
  • Compliant Management
  • Supplier Quality Management
  • Deviation Management
  • Training Management
  • Risk analysis
  • Complaints and recalls
  • Supplier production and analysis
  • Continuous improvements
  • Deviation and incident management
  • Effective quantitative risk management methods
  • Out of Specification Management
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We are compliant with:

ICH Q10 principles, cGMP, ISO 9000 series, 21 CFR Part 211, and Article 6 of Directive 2003/94/EC and Directive 91/412/EEC

Current Good Manufacturing Practice
International Council for Harmonisation
International Organization for Standardization

Industry best practices we follow to complement our QMS offerings:

  • Total Quality Management philosophy

  • Lean methodology

  • Six Sigma methodologies