Sold by: Tech Mahindra
Post Market Surveillance platform (PMS) is an agentic complaint disposition system for life sciences medtech organizations that automate complaint intake, triage, IMDRF Annex A-G coding, reportability, HSHA/FMEA risk workflows, and downstream compliance actions. It can be deployed as a standalone application or integrated via APIs into QMS platforms such as TrackWise, SAP, Veeva QMS, Oracle EQM, SFDC, CRM, portals, and other enterprise systems.
Overview
Overview:
PMS on AWS is a professional service offering that implements an end-to-end complaint disposition framework for regulated organizations. The solution uses specialized agents of 3Analytics across complaint intake, validation, complaint splitting, classification, IMDRF coding, reportability determination, follow-up, investigation support, HSHA/FMEA risk enrichment, QC, and trending or signal detection.
It supports intake from emails, CRM, web portals, distributor forms, call logs, PMS feeds, social media, and biomedical literature. The framework can run as a standalone complaint operations platform or integrate through secure APIs into existing QMS and safety ecosystems.
Built for AWS-based implementation , the solution is designed for modular deployment in the customer's environment with microservices, event-driven orchestration, managed storage, observability, and security controls aligned to enterprise standards.
Platform Highlights:
- Complaint triage and routing, including complaint vs non-complaint determination
- IMDRF Annex A-G extraction with structured outputs for downstream workflows
- SOP-driven reportability determination and regulatory timelines
- HSHA, FMEA, probability, severity, and investigation-ready risk enrichment
- Standalone deployment or API-led integration with TrackWise, SAP, and other QMS platforms
- Trending, clustering, and signal detection support for downstream analysis
Benefits:
- Faster complaint handling with near real-time core workflow processing
- Strong coding accuracy, consistency, and reduced manual effort
- Audit-ready operations with QC agents, traceability, and validation support
- Flexible deployment for both new programs and modernization of existing QMS landscapes
Key AWS Services Used
AWS Lambda Amazon Eventbridge Amazon SQS Amazon MQ Amazon ECS or AWS Fargate Amazon Bedrock Amazon Sagemaker Amazon OpenSearch Amazon S3 Amazon RDS AWS Direct Connect AWS DMS AWS KMS AWS IAM AWS Secrets Manager Amazon Cloudwatch AWS Cloudtrail AWS WAF Amazon Cognito
Highlights
- Automate triage, IMDRF Annex A-G coding, reportability, and risk workflows
- Deploy as a standalone app or integrate via APIs with QMS platforms
- Reduce manual effort with scalable, audit-ready agentic complaint processing
Details
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Delivery method
Deployed on AWS
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Vendor support
Deepak Gupta Deepak.Gupta11@techmahindra.com