Manager, Quality Assurance

TrackWise 8 Validation Plan

Document Version 2.0

May 2012

Document Version 2.0/ May 2012

Information in this document is subject to change without notice and, except as otherwise expressly agreed in writing by Sparta Systems, Inc., does not constitute in any way a representation, warranty or commitment on the part of Sparta Systems, Inc. The software described in this document and the documentation itself is furnished under a license agreement and/or nondisclosure agreement. The software and documentation may be used, copied, disclosed, transmitted, modified, and stored only as expressly permitted by those agreements.

TrackWise® and Sparta Systems® are registered trademarks of Sparta Systems, Inc. All other marks referenced herein are the trademarks or registered trademarks of Sparta Systems, Inc. or their respective owners. No license to any trademarks is granted herein.

Sparta Systems, Inc.
Holmdel Corporate Plaza
2137 Highway 35
Holmdel, New Jersey 07733
888.261.5948
/ Sparta Systems Europe, Ltd.
1 Hachoshlim Street
Herzliya, Israel 46724
972.9.970.6000

· Sparta Systems, Inc.
· 503 Silvercord Tower 2
30 Canton Road
TST, Kowloon
Hong Kong
+852.2376.9345

Sparta Systems, Inc. / Test Case Title / Page
TrackWise 8 Validation Plan / 5 of 14

-Information contained in this document is confidential and proprietary-

Document Version 2.0/ May 2012

Contents

1 Introduction 6

2 Scope 6

2.1 Exclusions 6

2.2 Terms and Definitions 7

3 Project Description 7

4 System Description 7

5 Responsibilities 9

5.1 SSI Management Team 9

5.2 SSI Validation Team 9

6 Validation Strategy 10

6.1 Validation Rationale 10

6.2 Validation Lifecycle 10

6.3 Functional Requirements & Design 11

6.4 Validation Planning 12

6.5 Installation Qualification 12

6.6 Operational Qualification 12

6.7 Performance Qualification 13

6.8 Validation Summary 13

6.9 Standard Operating Procedures 13

7 Validation Deliverables 13

8 Qualification Script Format 14

9 Validation Maintenance 14

9.1 Maintenance of Validated Status 14

9.2 Maintenance of Documentation 14

Sparta Systems, Inc. / Test Case Title / Page
TrackWise 8 Validation Plan / 5 of 14

-Information contained in this document is confidential and proprietary-

Document Version 2.0/ May 2012

Document Review and Approval

Prepared By:

Regina Mackiewicz
Senior Analyst, Product Quality
Name / Title / · Signature / · Date

Reviewed and Approved By:

Brian King
Director, Quality
Name / Title / · Signature / · Date
Sparta Systems, Inc. / Test Case Title / Page
TrackWise 8 Validation Plan / 5 of 14

-Information contained in this document is confidential and proprietary-

Document Version 2.0/ May 2012

Document History

Version / Supersedes / Effective Date / Summary of Changes / Justifications /
1.00 / · n/a / · December 2010 / · Initial Release
2.0 / · 1.00 / · See Reviewed and Approved By date. / PR 15157:
-update prepared, reviewed and approved by names
-update section 8 OQ Script format to reflect new OQ template
Sparta Systems, Inc. / Test Case Title / Page
TrackWise 8 Validation Plan / 5 of 14

-Information contained in this document is confidential and proprietary-

Document Version 2.0/ May 2012

1 Introduction

This Validation Plan is the controlling document for a suite of documents required to support the validation of the TrackWise 8 that has been developed by Sparta Systems, Inc. (SSI).

The purpose of this Validation Plan is to identify the following:

· The persons responsible for the execution of the validation project.

· The validation activities to be undertaken.

· A broad overview of the methods by which the validation activities will be undertaken.

· Documentation required supporting the validation activities, which will provide evidence that the validation project has been specified, designed, constructed, installed, and commissioned to an agreed scope of work.

2 Scope

This Validation Plan applies to TrackWise 8 in an un-configured state (e.g., out of the box).

2.1 Exclusions

The following items fall outside the scope of this validation:

· Execution of Installation Qualification (IQ) at a customer site

· Approval of the results of the IQ at a customer site

· Performance Qualification (PQ)

· Physical hardware

· TrackWise WebServices and Outbound WebServices

· TrackWise Electronic Reporting

· TrackWise Audit Execution Package

· Execution of the TrackWise Single Sign On OQ Scripts

Software products not developed by Sparta Systems to include the following, but not limited to:

· Operating Systems

· Oracle and MS SQL Server

· Apache Tomcat

· Crystal Reports XI, Crystal Reports 2008 and Business Objects Enterprise

· Documentum

· SharePoint

· Microsoft Office products

· Internet Explorer

· Single Sign-On

2.2 Terms and Definitions

Term / Definition /
CFR / · Code of Federal Regulations
· DS / · Design Specification
· FDA / · Food and Drug Administration
· FRS / · Functional Requirements Specification
· IQ / · Installation Qualification
· OQ / · Operational Qualification
· PQ / · Performance Qualification
· SOPs / · Standard Operating Procedures
· SSI / · Sparta Systems, Inc.
· TWBase / · An instance of TrackWise® that is used internal to SSI for tracking enhancements, new features, and discrepancies within the TrackWise® products.
· Validation / · Validation is the process where documented evidence provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics is evident.

3 Project Description

It is the intention of SSI to market a validation package to current and prospective clients that will minimize SSI clients risk and shorten their timeline for performing their own validation.

TrackWise 8 is a computerized system that can process and store data that is regulated by the Food and Drug Administration (FDA). As such, before TrackWise 8 can be used in this type of environment it must be validated in accordance with FDA regulations, specifically 21 CFR Part 11.

4 System Description

Almost every type of operation, whether performed by an individual or a group of people, requires some sort of tracking procedure for it to succeed. Whenever goals are set, tracking the progress towards these goals is of great importance. By tracking a process, all the people involved can tell what stage the process is in at any given moment, how much work has already been done, and what still remains to be done

TrackWise is designed to be a fully integrated and extremely configurable tracking system used for managing any event or action item, including, but not limited to, problem reports, bugs/defects, change requests, customer complaints, investigations, audit observations, and corrective actions.

Any tracking mechanism will need a basic building block. It should contain a variety of descriptive fields, and it needs to have a unique identifier that will enable the system to distinguish it from all other building blocks. In TrackWise, this building block is called a PR, which stands for Product Request. Each organization using the TrackWise system can designate any other code for this, according to its own need. Examples are: SR - for Service Request, AI - for Action Item, AR - for Action Request, MR - for Modification Request, LD - for sales leads, etc.

The principle objective of keeping track of tasks (Action Items, PRs) is to be able to know the status of the task at any given moment in time. A good tracking system should provide easy answers to questions such as: ‘How much progress was made on the task?’ ‘What is the status of this customer’s request?’ ‘Has problem X been resolved?’

Providing quick answers to such questions is of great importance, not only to managers and project leaders who need to prepare progress reports and the like, but also to team members and co-workers who can benefit greatly from coordinated work. The status of a PR is an important descriptor field, since it provides a qualifier that can immediately answer the aforementioned questions. TrackWise calls this qualifier the State of a PR.

The possible States of a PR can be pre-determined at each organization by the TrackWise administrator. They describe the various stages in the life cycle of a PR. For example: ‘Opened,’ ‘Work in Progress,’ ‘Test in Progress,’ ‘Closed’ and ‘Re-Opened’ are all possible states that may exist for PRs on the TrackWise system.

The work that is done in order to move a PR from one state to another is best described in terms of actions. Examples of ‘Started Work,’ ‘Called Customer,’ ‘Meeting,’ ‘Review,’ etc., are all appropriate descriptions of steps taken to further advance a certain PR. Accordingly, TrackWise uses the term Activity to describe actions that are taken in order to bring a PR closer to completion. Each PR can have many Activities performed during its life cycle. A group of Activity types is defined as a Task. When all of the activities are performed, the PR will go through a state change. The list of Activities posted becomes the Activity History of the PR.

Posting an Activity involves selecting from a pre-defined list of allowable Activities, which may vary depending on the State the PR is in. Certain Activities advance the PR to the next State, hopefully on towards its completion. At any State, authorized users must have the option of sending the PR back to a prior state by posting an activity. The order of activities is configurable based on the customer’s needs and is referred to as the “Workflow” for the specific project.

The TrackWise client interfaces will enable users to access centralized databases in real-time, allowing them to enter new PRs, update status (via posting activities), query, and report information. TrackWise will streamline the process and provide staff members and management with the necessary tools for achieving quick and timely resolutions and closure to problem and issue management.

TrackWise is designed to be a configurable tracking system, as it is clear that the validation of customized code is time consuming, labor intensive and very expensive.

5 Responsibilities

5.1 SSI Management Team

Title/Job Function / Responsibility /
President & Chief Executive Officer / · Responsible for the overall quality of the products that are developed and marketed by SSI.
· Vice President, Solutions Delivery & Support / · Manage all operations and services provided by the Solutions Delivery & Support department, including but not limited to: (a) production of software; (b) help desk to customers and members of Sparta Systems; (c) product support to Sales; (d) implementation and training services provided to our customers; and (e) IT.
Staff, train and supervise members of the Product Support department.
Ensure quality services are provided and that customer satisfaction is achieved with regard to same.
· Vice President, Research & Development / · Manages the Research & Development, Information Technology and Quality departments within SSI.
· Manager, Research & Development / · Participate in the design, development, enhancement, applying changes and fixes to our Windows and Web based software products. Supervise the activities of developers to ensure product quality and efficiency.
· Director, Corporate Quality / · Prepare and maintain all SSI’s Standard Operating Procedures (SOPs), and related documentation.
Oversee the Sparta Systems Quality Management System (QMS)
· Director, Quality / · Staff, train and supervise members of the Quality department. Ensure highest quality levels of SSI’s entire scope of operations, with a focus on the delivery of quality products, and services through product testing and documentation.

5.2 SSI Validation Team

The validation team consists of members of the management team along with the following:

· Title/Job Function / Responsibility
Quality Assurance Analyst(s) and Validation Engineer / · Development of Installation Qualification (IQ) Protocol and Scripts
Development of Operational Qualification (OQ) Protocol and Scripts
Execution of OQ
Development of an overall Validation Summary Report
· Technical Writer(s) / · Development of Standard Operation Procedures to include: TrackWise Administration; and TrackWise Configuration
Development of product documentation
· Product Specialist(s)/Solutions Delivery Analyst / · Subject Matter Experts in the operation and capability of TrackWise 8.
Execution of OQ

6 Validation Strategy

6.1 Validation Rationale

FDA regulations direct compliance with regulatory requirements for the validation and maintenance of computer systems used where data is to be used in support of a regulated process. Being that TrackWise 8 is used extensively in the FDA regulated environments, SSI has determined a business need to provide clients with a validation package for TrackWise 8 that would satisfy the FDA regulations for Installation Qualification and Operational Qualification. SSI has further determined that a business need exists for providing clients with Standard Operating Procedures (SOPs) for both TrackWise Administration and TrackWise Configuration. These SOPs provide the detail for the administration and configuration of TrackWise® as presented in SSI lead training.

6.2 Validation Lifecycle

SSI’s validation lifecycle is depicted in the following figure.

The approach to validation is to show documented evidence that a computer systems does what it is required to do. The SSI activities identified in this Validation Plan will provide the “documented” evidence [1]that TrackWise 8 does what it is required to do as specified in its Functional Requirements Specification.

6.3 Functional Requirements & Design

The Functional Requirements and Design Specifications are internal SSI documents that describe the features and functions from both a business and technical perspective. The Functional Requirements and Design Specifications have been developed in accordance with approved SSI SOPs. The Functional Requirements & Design, TargetProcess Users Stories and the TrackWise manuals listed below will be the foundation for the OQ.

· TrackWise Web Admin Guide

· TrackWise Audit Manager Guide

· TrackWise Configuration Migrator Guide

· TrackWise Coordinator Guide

· TrackWise Document Management Guide

· TrackWise Document Management Install Guide