Project Process

Padmini Pisipati

Compliance / Process Consultant

Mobile: 978-***-****

Email: ************@*****.***

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Keywords: CMMI, ISO 9001:2000, ITIL, Six Sigma, CSV, Software Quality,

COBIT, CSQA, SoX, HIPPA

Software Quality Consultant with 4+ years of experience including

specialization in Auditing, CoBIT, 21 CFR Part 11 Compliance & SoX.

Profile Overview

Software Quality:

. Model-based Gap Analysis, Process Definition, Process Implementation,

Process Facilitation, Process Improvement, Project Management.

. Extensive experience with all the stages of the System Development

Life Cycle (SDLC), Test Lifecycles, approach to computer systems

development.

. Good Knowledge of statistical processes such as SPC, Six Sigma, Design

of Experiments, Trend Analysis, NP Charts,Pareto Analysis, Fishbone

diagrams, etc.

. Exposure to Quality Frameworks like CMMI, ISO, ITIL

Computer System Validation:

. Experience in CSV including Compliance Assessments, Validation Plans,

User Requirement Specifications (URS), Functional Requirement

Specifications (FRS), Design Specifications (DS), Validation protocols

( IQ/OQ/PQ) and Summary reports in compliance with GxP.

. Excellent experience of performing GAP analysis, preparing Remediation

Plans and Retrospective Validation.

. Developed strategies and plans to install different types of systems

that fall under GxP (cGMP, GCP and GLP) and GAMP.

. Developed User Requirements (URS) in coordination with the end users

and System owners.

. Experience in writing protocols (IQ/ OQ/ PQs), Test Plans, Test

Scripts and Test Cases.

. Prepared and reviewed Traceability Matrix (TM).

. Worked with a SOP committee in writing/reviewing/revising software and

hardware Standard Operating Procedures (SOPs) and User Manuals to

ensure they meet FDA requirements

. Extensive experience in 21 CFR Part 11 compliance with client/server

and/or web enabled applications and Laboratory applications.

. Involved in the validation training programs to ensure Regulatory

Compliance.

. Ability to work within the company IT Corporate policies to ensure

Compliance and investigate and develop strategies for process

improvements.

. Strong hands on experience with MS-Office tools including, MS-Project,

Word, Visio, Access, Outlook, Excel and Power Point.

ACADEMIC

< Masters in Business Administration (Information Systems and Finance) -

Institute of Public Enterprise, India

< Bachelors in Technology in Electronics and Communication Engineering

(JNTU), India

TECHNICAL SKILLS

Operating Systems MS-Dos, Windows (NT, 95, 98, 2000), UNIX, XP, Vista

Web Related HTML, DHTML

Testing / Quick Test Professional, UAT, and Regression tests,

Test Management Test Strategy and Planning, Test Metrics Reporting,

Tools Test Scenario Identification, Test Case Preparation

and Execution, and Bug Reporting.

Bug Tracking Tools HP Quality Center 9.2

Others FrontPage, Adobe Photoshop, Adobe Acrobat, MS Visio

Tools & Utilities Share Point, Visual Source Safe, MS Project Plan,

Lotus Notes, HP SM7, Electronic Document Management

Tool (eDM)

PROJECTS PROFILE

Philips IT Health Care, Boston, MA

Mar'09 - Present

Philips Medical Systems (PMS), subsidiary of Philips Electronics

headquartered in Netherlands is one of the industry leaders in developing

tools that deliver value throughout the complete cycle of care - from

disease prevention to screening & diagnosis, to treatment, health

management & monitoring - in key areas including cardiology, oncology,

critical care and women's health.

Client is already on SAP, which provides them the global control needed to

optimize their business processes. PMS has purchased SAP version 4.6C as

the basis for the implementation of reengineered business processes. SAP

provides information management capabilities to PMS by helping to manage

their financial, manufacturing, sales and distribution functions, among

others, that are essential to enterprise operations. The Master Protocol

addresses the need for compliance and validation activities to be focused

on the identified SAP modules and programming language

Satyam takes the responsibility of providing Consulting in Validation Space

to the Client PMS GLASS (Philips Medical Systems Global Application Shared

Services).

Contribution:

. Mentor the project teams regarding application of policies and procedures

related to System Development Life Cycle (SDLC), Computer System

Validation (CSV), Software Quality and Change Management.

. Assist the project teams in developing project quality plans to ensure

compliance with applicable policies and procedures, identify required

activities and deliverables, review and approve the project quality plans.

. Review/Audit of project deliverables such as Validation Plans, System

Requirements Specification, Design Specifications, Test Plans, Test

Reports, Software Verification and Validation Reports.

. Approve the Lotus Notes based Change Control (LNcc) Documents.

. Generating and communicating the LNcc Metrics through Weekly Monitoring

Reports.

. Prepared Consolidated Report on Change Control Requests once in 6 months

to know the Trend and performance.

. Performed RCA (Root Cause Analysis) for defects and issues that arise

during production.

. Develop the processes such as Training, On boarding, Off boarding.

. Develop compliance policies and procedures. Assists in the enforcement of

compliance policy, procedures and standards.

. Facilitated meetings with the Project Managers to gather and document

necessary process changes.

. Conduct Internal Audits and participate in External Regulatory Audits.

. Develop Training Materials and train the associates on the Processes,

Procedures and Templates.

. Manage and monitor Operations and Back Office Team.

. Undergone training on Share Point and implemented the same successfully

in Philips IT.

. Responsible for Run Book CMCC (Change Management Change Control) Analysis

and communicating the same to Management.

. Generating KPI Dashboards monthly.

. Worked on Camel Live Link.

. Played a key role in UAT for the new tool namely HP SM7( ITIL based

tool).

. Validated the tool HP SM7 in the Electronic Data Capture System to assure

that electronic records and electronic signatures are in compliance with

21 CFR Part 11.

. Perform CAPA as and when required to attain continual improvement.

. Involved in the creation of Validation Plan, Validation Protocol and

Validation Summary report documents.

. Prepared Test Plan for Operation Qualification, Performance Qualification

(PQ), and prepared a Validation Summary Report.

. Developed Deviation Report for Validation, change control and QA findings

on Validation Protocols

. Trained all the associates in Philips from migrating from existing tool

ie Lotus Notes to new tool ie HP SM7

. Generating and communicating the SoD (Segregation of Duties) Conflict

Reports monthly.

. Performing Role Clean Up Analysis every quarter to ensure the

Authorizations are current.

Glaxo SmithKline (GSK), Hyderabad, India

Feb'07 - Feb'09

GSK headquartered in the UK with operations based in the US, it is one of

the industry leaders, with an estimated seven per cent of the world's

pharmaceutical market. It also involves in helping to developing countries

by providing discounted medicines where they are the most needed.

Satyam takes the responsibility of supporting major projects within GSK

namely Production Support, MERPS, MERPS2, BEBOP, and MBD (MERPS Benefit

Delivery). MERPS Benefit Delivery is the Development project in GSK. MBD is

responsible for all the developments that take place in GSK involving

complete life cycle.

Contribution:

Process Analysis:

. Conducting Gap Analysis for AS-IS client processes and suggesting GAMP 4

based TO-BE

Processes for the client on a need basis

Process Definition:

. Defined process for Incident Management, Test Process, Configuration

Management, Document Management

Process Implementation / Improvements

. Involved in project management and coordination effort for the Computer

Systems enhancements implementations according to FDA Guidelines, GLP, GMP

and 21CFR Part 11.

. Involved in the creation of Change control Proposal, GAP analysis, SOP

development and project plan.

. Prepared Risk Assessment in compliance with 21 CFR Part 11, SoX.

. Developed local level Standard Operating Procedures (SOPs) which included

both the User and the Administrative SOPs.

. Reviewed URS and FRS interacting with internal departments like quality,

project engineering, production, and other Lead Users.

. Developed Traceability Matrix (TM) to track requirements

. Prepared Installation Qualification (IQ), Operation Qualification (OQ),

Performance Qualification (PQ), and prepared a Final Validation Report.

. Developed Corrective Action/ Preventive Action(CAPA) for the variances

and deviations in the Qualification process.

. Prepared summary report for the project.

. Compute and publish Delivery Metrics every month as per the ITSA to

appropriate stakeholders

. Publish account snapshot for projects & services

. Monitor compliance with GSK Policies and Procedures by reviewing/auditing

project deliverables such as project quality plans, Validation Plans,

System Requirements Specifications, Design Specifications, Test Plans,

Test Specifications, Test Results, Test Reports

. Envisage and discuss Process Improvements for GSK SAP projects with GSK

SAP FLCLs(Full Life Cycle Leaders).

. Reviewing the metrics for Quality of deliverables for every phase of SDLC

and implementing process change CAPA (Corrective and Preventive Action) to

attain Continual Improvement.

. Analyzing Incidents (defects) using Statistical Tools and methodologies

like Trend Analysis, Pareto Analysis, Why-Why and How-How Analysis.

. Performed RCA (Root Cause Analysis) & FMEA for defects and as well as for

projects when the project is behind the schedule.

. Conduct monthly Kaizen Meetings to review the status of continual

improvement initiatives and prompt appropriate action.

. Collect and analyze data related to lessons learnt and best practices,

document findings and recommendations.

. Review meetings with the GCV (Global Computer Validation) on the project

deliverables, metrics and continual improvement action initiates.

. Implemented Green Belt projects in the project teams.

Process Verification:

. Manage & facilitate PPM, Client & CMMI Audits.

. Conducted Internal Audits for various GSK projects and played a lead role

in submitting the Audit Closure Report.

. Conduct monthly PMO meeting with GSK SAP FLCLs

. Heading the client audits on various SAP Validation Projects.

Other Responsibilities:

. Manage and monitor Back Office Team & IT-Quality Team

. Manage Quality escalations with client.

. Assist the Project Teams in preparing for Internal and External Audits.

. Assist the team members to conduct Knowledge Sharing sessions on Industry

Standards and best practices related to implementation of FDA -regulated

information systems.

. Training Project and QA team members on

o GxP - Good Manufacturing/Clinical/Laboratory/Distribution Practices

o Validation Fundamentals

o GSOPs for SDLC phases

o Governance Documentation viz, Documentation Management Plan,

Configuration Management Plan and Incident Management Plan,21 CFR Part 11.

o Review Rigor

Solution Manager Project:

Contribution:

As a TIP & Test Manager, my responsibilities included:

. Responsible for overseeing the Documentation and Quality procedures

related to the project.

. Responsible for resolving issues faced during implementation of Solution

Manager.

. Managing all aspects of the Testing Process.

. Perform Test Initialisation i.e. all preliminary actions required to be

completed before the Tester can execute the Test Case.

. Drafting the Incident Records and ensure that all Incidents (defects)

raised during testing are completed and closed.

. Controlling the Test Pack documentation until the Testing Closure Report

has been approved.

. Review and approve executed Test Cases and Testing Closure Reports.

MERPS II Modular MRP Phase V - GSK:

Setup and Operationalize a Project Management Office (PMO) by establishing

IT process governance to provide process improvement. Align processes

between Satyam QMS and iQMS (Integrated Quality Management System).

Contribution:

. Identify, plan, setup and implement organizational need based Best

Practices for Project Governance

. Establish governance structures, policies, procedures and associated

templates & guidelines which are required for PMO

. Pilot and rollout new processes monitor and evaluate process

effectiveness through reviews & audits and fine-tune process to realize

continuous process improvements.

. Developing policies, processes, templates and guidelines based on PMI's

PMBOK.

. Conducting Process reviews of deliverables such as project quality plans,

validation plans

. Deployment and audit of the processes

. Identify training needs and training the team members on GxP, Validation

Fundamentals, GSOPs and other Project Specific Documents.

. Conduct periodic compliance audits to ensure process adherence.

Mahindra Satyam, Hyderabad, India

Dec'06 - Jan'07

Satyam's Consulting Division launched QVAL (Quality and Validation)

catering the need of Pharmaceutical Industry - IT Services. The QMS was

based on GAMP Framework and FDA Regulations.

Contribution:

. Process Definition

o Document Management

o Incident Management

o Infrastructure Qualification

o Business Continuity

o Metrics

. Developed templates and procedures for QVAL

. Reviewed the processes developed and recommended improvements

. Identified Gaps in Satyam QVAL based on Client (GSK) QMS.

. Lead the CMMI Version 1.2 Assessment for Mahindra Satyam Hyderabad

Organizational Unit conducted by KPMG (External Audit), for which the

assessment objectives have been met successfully.

Johnson & Johnson, Nutritionals, Hyderabad, India

Aug'06 - Nov'06

Nutritionals project maintains the list of all drugs based on departments.

Contribution:

As a Compliance Analyst, was responsible for:

. Process Implementation Support covering activities such as

o Project Planning

o Process tailoring

o Set up of project schedule on PM Tool

o Project records maintenance

o Metrics collection and analysis, software release audits etc.

. Conducted process compliance verifications to identify process issues and

escalate to Project Managers.

. Involved in Computer Systems Validation according to FDA Guidelines, GLP,

GMP and 21CFR Part 11.

. Regular interaction with designers, developers and Systems analysts to

gather requirement specifications.

. Reviewed URS and FRS interacting with internal departments like quality,

project engineering, production, and other Lead Users.

. Prepared Installation Qualification (IQ), Operation Qualification (OQ),

Performance Qualification (PQ), and prepared a Final Validation Report.

. Developed Corrective Action Response Report for QA findings on Validation

Protocols

. Performed testing of the application to verify the requirements.

. Developed Traceability Matrix (TM) to track requirements.

. Based on the verified inventory, Performed Gap Analysis to determine the

21 CFR Part 11 compliance and prepared the remediation plan.

. Involved in developing local level Standard Operating Procedures (SOPs)

. Involved in creation of Test Plan, test cases and test Scripts for

validating different tables, queries and forms.

. Assisted the end user in completing the User Acceptance Testing (UAT).

. Conducted Process Training for new members joining the project

EMC, Power link, Hyderabad, India

Jun'06 - Aug'06

Power link is a web logic portal application catering to the needs of

customers of EMC world wide. This project application accesses central

repository for documenting all product related information of EMC. Since it

is a world wide enterprise application, the information should be available

24/7 for the customer thus calling for effective and efficient processes to

ensure high end availability of information in the system.

Contribution:

. Process Implementation Support covering activities such as

o Project Planning

o Process tailoring

o Set up of project schedule on PM Tool

o Project records maintenance

o Metrics collection and analysis, software release audits etc.

. Conducted process compliance verifications to identify process issues and

escalate to Project Managers.

. Conducted Process Training for new members joining the project

. Conducted Internal Audits of projects and service functions

. Assist project team members in identifying risk management and identify

high risk projects upfront.

. Enable projects towards higher process maturity levels, anchor and enable

innovations.

. Ensure project's compliance to process and rate each project at CMMi

Levels.

Alliance IT Consulting, Hyderabad, India

Apr'06 - Jun'06

Conduct Internal Audit and ensure ISO 9001:2000 process compliance.

Contribution:

. Preparation of Audits Plan and Schedule.

. Preparing the Pre Audit Review (Audit program and checklist) for the

audit area allotted to them on discussion with the Team Leader

. Preparation of Advance Intimations to be sent to Auditees

. Conducting the audit

. Preparing the Draft and Final audit report.

. Escalating major audit observation to the respective department head

. Ensure closure of Non-Compliances

Process and project deployment for CMMI Level 5 (Staged Representation)

Assessment.

Contribution:

As an Assessment Team Member was responsible for

. Conducting interviews

. Reviewing project documents such as project quality plans and SDLC

Deliverables

. Consolidating & validating review data

. Preparing assessment report

As a Product and Process Quality Assurance representative, was responsible

for

. Facilitating the team in understanding and using the templates designed

for the CMMI process deployment

. Auditing the project documents

. Coordinating with the team

. Capturing the requirements of the project in Customer Requirements

Specification Document and System Requirements Specifications Document

. Maintaining the Requirement Traceability Matrix

. Reviewing the project documents

. Develop Training Materials.

. Reviewing project deployment progress

ACHIEVEMENTS

< Appreciation from the Client for the hard work and commitment to the ECC

6.0 Upgrade and Unicode Conversion project.

< Appreciation from the Client Philips IT Health Care for my consistent

performance throughout the year 2009-10 for which my contract has been

extended.

< Awarded "Key Associate Retention Scheme" for the Quarter Apr, 09 to Jun,

09 for my outstanding performance.

< Secured Staggered Cash Award of Hundred Thousand Rupees for my

meritorious performance in MahindraSatyam for the years 2008 & 2009

< Secured "BRAVO Award" in recognition of my services for increasing

significant value addition to our organization

< White Paper namely "Testing Times - Changing Customer Expectation during

Recession and Retaining Customer Confidence" has been selected for the

9th Annual International STC Conference, 2009 conducted by QAI

< Successful implementation of checklist for all the SDLC deliverables in

compliance with the client QMS

< Core Member for ISO 9001: 2000 surveillance audit.

< Appreciation mail for successfully meeting the Assessment Objectives for

CMM1 Version 1.2 Assessment conducted by KPMG.

< Monitored the customer services including periodical analysis of customer

concerns, Incident Analysis, customer feedbacks on quality complaints &

related countermeasure plans

< Appreciation from the client GSK for the Consolidated Incident Report for

the year 2007-08

< Received Justice Jagan Mohan Reddy Scholarship for standing first in

PGDBM

< Received Silver Medal in B.Tech for highest aggregate in Mathematics

< National Scholarship in Intermediate (awarded by Ministry of Human

Resources and Development, Dept. of Education, Govt. of India)

CERTIFICATIONS

< CSQA

< ITIL Foundation

< Six Sigma Green Belt (Mahindra Satyam)

< ISO 9001 : 2000

< Global Computer Validation from GlaxoSmithKline -UK

< Satyam Function Point Champion

DOMAINS

< Pharmaceuticals, Telecom, Finance, Retail

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