Serialization Program
Management

Workshop
on Serialization

  • Overall business requirement gathering
  • High level business process
  • Team selection - steering commmittee and program sponsoring team
  • Core Working Team Selection - Roles and responsibilty
  • Budget and resource planning (hardware software license fee/cloud fee/capital vs opex)

L1 to L5 Product and Vendor Level Assessment

  • Vendor Selection - RfI (Request for Information)
  • Criteria for vendor selection - Recommendation
  • Vendor Finalization
  • SOW / MSA /SLA Preparation
  • Contract Signoff
Vendor Level Assessment
Project Managemen

Project Management

  • RACI Matrix (responsible / accountable / consulted / informed)
  • Project Kick off Meeting
  • Kick off meeting - agenda / priority and timeline discussion
  • Project Charter
  • Weekly Biweekly Meeting Conduct
  • Steering Committee Meeting Set up
  • Project Status Udpate and Escalation
  • CMO/CPO on Board
  • On Board document preparation and following through completion
  • Project Tracking

Validation Documentation

  • Vendor evaluation
  • Master validation plan
  • User requirement specification
  • Functional specification
  • Change control IQ, OQ, PQ
  • Validation summary report
  • Traceabilty matrix
  • Risk Assessment.
Validation Documentation
Technical Support

Technical Support

  • License support if required (microsoft / sql / oracle / cloud /aws / hosting )
  • Client and server backup/restore/disaster recovery plan
  • Master data management
  • Other system integration (ERP, middleware etc.)
  • 3rd party integration tool
  • Integration with warehouse management system and documentation
  • Techno functional documentaiton
  • Risk assessment and mitigation documentation