PROJECT INITIATION REPORT

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1 PROJECT INITIATION REPORT March TradeTicity LLC, USA Pharmaceutical Serialization implementation for XXXX Project initiation report Author XXXX Company TradeTicity LLC Version 1.0 Date: Document name: PIR_Demo.docx

2 Document revisions Final revision: Author: Date: Approvals: Previous versions Version Date Description Initial draft Approvers signatures We, the undersigned, confirm with our signature that document has received the status of Approved final revision List Name Project Role Date Signature Project sponsor Project manager Distribution list Document has been distributed to following team and customer members List Name Project Role

3 Glossary of Acronyms Following acronyms with corresponding explanations are used in the document List Acronym Meaning Explanation PM Project management SOW Statement of work Explanation of tasks and activities necessary to complete the project

4 Table of content Purpose of the document Project definition XXXX /TradeTicity - Serialization (Support to Implementation of TradeTicity Serialization system for XXXXX) Purpose and goals of the project Project team with description of roles and responsibilities Project organization structure Communication plan Project time schedule Project control points (Milestones) Project deliverables Risk management and mitigation measures plan Quality management plan Description of the project scope Activity 1: Defining success criteria, detailing the project plan and kick-off Activity 2 - defining current state and information flow Activity 3 implementing the serialization system Activity 4 Moving to production and closing the project... 18

5 Purpose of the document Purpose of this document is to define project team and organizational structure, milestones, deliverables, project management procedures, project plan and scope of work, project responsibilities and roles. 1 Project definition XXXX /TradeTicity - Serialization (Support to Implementation of TradeTicity Serialization system for Galex) In this chapter following will be described 1. Purpose and goals of the project 2. Project team, with description of the roles and responsibilities 3. Project Organization Structure 4. Communication plan 5. Project management plan 6. Overview of the phases and time schedule 7. Project milestones 8. Project deliverables with Table of content for each deliverable 9. Project risk management plan 10. Quality assurance plan 1.1 Purpose and goals of the project The goal of the project is to prepare Galex for pharmaceutical serialization in EU countries, as defined by EU directive 2011/62 and national law of Republic of XXXX. During the Phase I of the project, confirmed by signed agreement of the cooperation numbered WW 01/2014 TradeTicity will support XXXXX d.d. to: Define the requirements for serialization Prepare serialization blueprint Perform necessary process transformation Integrate TradeTicity QRLogic system for serialization into production Align with regulatory requirements for XXXX by Prepare for serialization on EU level Produce initial test series of drugs printing the obligatory label in form of Datamatrix on limited test number of packages Once the pilot printing of the tags is completed, and all necessary documentation submitted to Galex this project will be considered completed. 1.2 Project team with description of roles and responsibilities Role Team members Responsibilities Project sponsors/ Supervisory board XXXXX:, CEO TradeTicity: XXXXXX XXXXX: Final project implementation confirmation Project deliverables approval Overall project support Project issues and change request resolution TradeTicity: Project support

6 Role Team members Responsibilities Project management XXXXX: TradeTicity: Krešimir Đuračić Prepare reports for supervisory board Prepare meeting minutes from PM meetings Leading the project securing the timely implementation according to project plan Project change management documentation Updates to project plan and schedule Management of project documentation Scheduling and leading the project meetings Overall management of project teams Project team XXXX: head of drug manufacturing, head of packaging, legislation and licensing expert, sales manager, head of supply chain, head of procurement, head of quality assurance. head of marketing, head of IT TradeTicity: XXXXXX, system integration XXXXX, IT architect XXXX, legislation and operational environment XXXXX, change management & strategy XXXXX, business analyst Team members are responsible to project manager for timely execution of project plan. Team members are responsible for providing exact, precise and honest information in order to timely complete project tasks and activities

7 Team members contact details Address book Name Company Phone number

8 1.3 Project organization structure xxxx Project sponsors xxxx xxxx Tradeticity Krešimir Đuraćić Legislation and business requirements Head of drug manufacturing (production) Organization change management and strategy Head of packaging Business processes and analysis Legislation and licencing System integration Sales manager IT architecture and solutioning Supply chain manager Head of procurement Head of QA Head of marketing Head of IT Tradeticity Galex 1.4 Communication plan In order to secure successful and timely project implementation communication during the scope of the project is of extreme essence. TradeTicity expects xxxx to respond to all business inquiries within 2 working days. Official communication, beside standard documents is also considered to be all electronic communication. Project official language is English.

9 Meeting schedule Meeting description Frequency Purpose Supervisory board Monthly Determination of the meeting project status, acceptance of the deliverables, risk analysis, key decisions agreement PM meeting Weekly Project health assessment, project performance and closed tasks and activities, definition of the activities for the next period Team meeting Per request by Delegation of business PM activities and issue resolution Deliverable Meeting Documentation moderator, Meeting minutes, TradeTicity xxxx, TradeTicity Project report health Meeting minutes 1.5 Project time schedule Time schedule for this project is defined in format.mpp, which will be used during the scope of the project. Responsibility for keeping the project plan updated is on TradeTicity project manager. Time schedule should have visible or major project milestones. Upon entering each Activity, project managers will prepare more detailed project plan, in order to secure timely project execution.

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