PMP for Development Projects

Project Management Planfor

PharmaReady Implementation

Template Change History

Copyright © TAKE SOLUTIONS. This document contains confidential information. No part of this document may be reproduced or distributed without prior permission (All Quality documents in the Repository alone shall be termed as CONTROLLED) Page 1 of 24

Table of Contents

1.Introduction

1.1Project Overview

1.2Project Milestones

1.3Payment Milestones

1.4References

1.5Acronyms and Descriptions

2.Project Organization

2.1Project Team Structure

2.2Important Contacts

2.3Stake holder matrix

2.4Project Communication

2.5Problem Escalation

3.Project Specific Practices

4.Project Life Cycle Model

5.Project Planning

5.1Initial Estimation

5.2Detailed estimation

5.3Assumptions, Dependencies and Constraints

5.3.1Assumptions

5.3.2Dependencies

5.3.3Constraints

5.4Manpower Resources

5.5Training and Skill upgrade

5.6Hardware Resources

5.7Software Resources

5.8Work environment

5.9Organization process assets

5.10Risks

6.Metrics

6.1Process and Product Metrics

6.2Quality Assurance Metrics

7.CBRM

7.1Configuration and Data Management

7.2Change Management

7.3Build Management

7.4Release Management

7.5Backup and Archival

7.6Do’s and Don’ts

8.Decision Analysis and Resolution Plan

9.Causal Analysis and Resolution Plan

10.Project Tracking, Monitoring and Control

10.1Project Tracking Records

10.2Audit Tracking Mechanism

10.3Project Plan Revisit

11.Change History

Copyright © TAKE SOLUTIONS. This document contains confidential information. No part of this document may be reproduced or distributed without prior permission (All Quality documents in the Repository alone shall be termed as CONTROLLED) Page 1 of 24

1.Introduction

Project Overview

TAKE has its own product “PharmaReady”, offering for Pharma Companies on the following business functions:

Electronic Submissions to different market agencies on the products

Structured Product Labeling

Document Management System

Training Records Management System

Paper publishing Module

This project is for Implementation of the PharmaReady Product for its clients. Take will perform implementation of the Product based on the license procured by the client, by performing IQ and OQ in TAKE’s Custom IQ OQ template that was followed from its 4.3 version of the product.

Any Project management, Risk assessment pertaining to specific implementation will be taken care by the respective customers.

For L0 support the customers will either call the support No. to raise an issue or send a mail to the PharmaReady support mail address. On receiving the Issue support engineer will analyze and provide appropriate resolution to the customer

These issues will be then logged in to the internal Logging system for future references and tracking.

Project Milestones

Payment Milestones

Since this is a support and implementation to the product, payment milestones are not applicable.

References

Acronyms and Descriptions

2.Project Organization

Project Team Structure

Important Contacts

Note : since this is a support to all the PharmaReady clients specific customer is not highlighted.

Stake holder matrix

Project Communication

Problem Escalation

3.Project Specific Practices

1. Hardware and software requirement documents license wise.

1. PharmaReady Implementation plan
2. Implementation Completion Report – project closure document from client on project completions.
3. Validation documents:

1. User Name- TRAINING CERTIFICATE
2. PharmaReady Training Guides

4.Project Life Cycle Model

1. Take will perform implementation based on the implementation plan prepared and accepted by customer
2. Take will perform IQ and OQ with TAKE’s Custom template
3. On successful completion of the implementation “Implementation completion Certificate” will be obtained from the customer
4. For L0 Support on receiving issues entire by mail or phone call Support engineer will analyze and provide appropriate solutions. Record the issue in the internal logging system for future tracking.

5.Project Planning

Initial Estimation

Detailed estimation

Assumptions, Dependencies and Constraints

5.1.1Assumptions

1. TAKE will participate only in the Implementation and support to customer and all the Project management for the individual customer will be taken care by respective customer
2. TAKE will perform IQ and OQ with its template that was in place since the 4.3 version of the product
3. Temporary additional resources if any will be addedon need basis.

5.1.2Dependencies

Delay in clarifications (if any) from the customer will delay the problem resolution

If there are any issues that requires deep troubleshooting would require support from the product engineering team

5.1.3Constraints

Not foreseen any as of now

Manpower Resources

• Project Management Skills
• Domain skills
• Communication
• Leadership
• Inter Personal skills
• Problem Solving and Facilitation skills
• Measurement techniques
• Review techniques

• Process awareness and understanding
• Implementation Skills

• Domain skills
• Communication
• Leadership
• Inter Personal skills
• Problem Solving and Facilitation skills
• Measurement techniques
• Review techniques
• Configuration Management

• Process awareness and understanding
• Implementation skills

• Communication
• Process awareness and understanding
• Implementation skills

The required resources have already been identified. Since the identified resources have the expected skill and no gaps found between required and available, no training is envisaged at this juncture. In case of any change in the stakeholder matrix and if there is any gap in the expected skill, necessary training would be planned and imparted

Training and Skill upgrade

Since the identified resources for this PharmaReady implementation have already been worked in various modules of the existing application and if required, the training needs would be identified and tracked to closure.

PharmaReady product Skills required as follows

1. Product Orientation -Learner Level

In case of external training, necessary approval shall be obtained from GDH and the training request would be sent to the Training department for further course of actions.

Hardware Resources

Software Resources

Work environment

Organization process assets

This project shall inherit and use the following from the organization’s process assets viz. Process Capability Baseline, Risk database, Best practices and Lessons learnt.

Risks

All the project risks are listed and tracked through Risk Track Sheet, which is available in the following path

Add the SVN path
Metrics

Process and Product Metrics

Quality Assurance Metrics

6.CBRM

Configuration and Data Management

SVN is identified as the configuration management tool for artifacts and document base.

The list of configurable items would be identified and tracked in the CI Data Track sheet, which is available in

The following work sheets (Tabs) would be made available in the CIDTS

• Folder Structure Rights: In this sheet, SVN folder structures that are created for this product is mentioned. This sheet would contain the information of top two levels of folder structures, “access rights for each folder and roles” and “the snapshot of SVN folder structure that is created for this product”.

.

• Configurable Items: The configurable items (CI) for this project are identified and mentioned in this sheet. The following are a few key info of each CI that are being tracked here i.e. “file naming convention”, “baseline criteria & version”, etc,.
• Data and Records: All the documents and the records that are maintained for this product with its full path and naming convention are recorded here.
• Managed and Controlled: Managed and Control items are identified and mentioned in this sheet. The following are a few key info of each Managed and Control that are being tracked here i.e. “file naming convention”, “baseline criteria & version”, etc,
• CI Version History: The version of the CI’s is tracked here specifying the current and obsolete versions. Movement to the controlled area is also recorded in this sheet along with the baseline request information.
• CI Baseline: The entire work product’s baseline versioning information is maintained here along with the common baseline

Change Management

NA

Note: Since this is a Support project Build management is not applicable

Build Management

Note: Since this is a Support project Build management is not applicable

Release Management

Note: Since this is a Support project Build management is not applicable

Backup and Archival

Respective customer will take care of backup of their servers based on their internal policy. For the local assets and repository will be backed up as per Infra team backup process.

Do’s and Don’ts

7.Decision Analysis and Resolution Plan

This section will be filled when DAR is performed

8.Causal Analysis and Resolution Plan

This section will be filled when CAR is performed.

9.Project Tracking, Monitoring and Control

Project Tracking Records

Audit Tracking Mechanism