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.
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