Project Management Methodology

When you decide to work with TradeTicity, we will help you to define the scope and plan for your serialization project. The Project Plan that we create will define the key objectives, organization, scope, applied methodology, activities and deliverables. This detailed plan helps you to control the budget and the timelines effectively and minimise disruption to your current operations.

Tradeticity emphasizes quality management. The Project plan provides the quality and validation framework, ensuring the deliverance of your fully validated software solution. Project phases, milestones and activities are thoroughly defined in the Project Plan and are managed through the Activity Plan tool. The Initial Activity Plan is delivered to the customer as an appendix to the Project Plan, while ongoing project scheduling is managed through a working copy of the Activity Plan, throughout the project life cycle.

Our Quality management model is based on the principles of EU GMP Annex 11 and GAMP 5 guidelines.


The primary quality objectives are:

  • Seamless user requirements definition through formal URS document,
  • Establishment of a formal Validation Plan,
  • Preparation of IQ, OQ and PQ protocols and test cases,
  • Validation review and approval, preparation of the Validation Summary Report.


Software Deliverables

Software deliverables are divided into three separate sections of the CureSync software:


Test environment

This environment is used for informal testing, user education and presentation purposes.


Validation (QA) environment

This environment is used for formal validation (IQ, OQ, PQ) testing.


Pre-production/ Production environment

After validation testing is successfully completed in the Validation environment, the pre-production environment becomes “production” environment, ready for go-live.

Documentation Deliverables

  • Project Plan (PP) with subsidiary management documents and records
  • Configuration Specification (CS)
  • Functional Specification (FS)
  • User Manual (UM)
  • Administration Manual (AM)
  • Integration Manual (IM)
  • Risk Assessment (RA)
  • Validation Plan (VP)
  • Installation Qualification (IQ) protocol, test cases and report
  • Operational Qualification (OQ) protocol, test cases and report
  • Performance Qualification (PQ) protocol, test cases and report
  • Traceability Matrix (TRM)
  • Validation Summary Report (VSR)