Manager, Quality Assurance

TrackWise 8.3 Validation Summary Report

Document Version 1.2

June 2011 Document Version 1.2/ June 2011

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.

Proprietary Information Notice Information contained herewith should not be disclosed to any other party without the explicit written permission of Sparta Systems, Inc.

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

888.261.5948 972.9.970.6000 [email protected] [email protected]

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

Sparta Systems, Inc. Test Case Title Page

+852.2376.9345 [email protected]

TrackWise Coordinator 7.0 Administration Guide Revision 1.00 / December 29, 2006 Document Version 1.2/ June 2011

Contents

Document Review and Approval Prepared By:

Lynn Ballas

Analyst, Quality Name / Title Signature Date

Reviewed and Approved By: Garry Heon

Director, Quality Name / Title Signature Date

TrackWise 8.3 Validation Summary Report 6 of 18 -Information contained in this document is confidential and proprietary- © 2011 Sparta Systems Inc. All Rights Reserved D O C U M E N T H I S T O R Y Version Supersedes Effective Date Summary of Changes / Justifications 1.0 n/a December 2010 Initial Release 1.1 1.0 December 2010 Changed the text in section 1.1 from “TrackWise 7.0 IQ/OQ Validation Package” to “TrackWise 8 IQ/OQ Validation Package” Added the cross reference to OQ scripts for the deviations identified in section 6.2 1.2 1.1 June 2011 Updated Legal page; updated the Current Deviations table.

TrackWise 8.3 Validation Summary Report 7 of 18 -Information contained in this document is confidential and proprietary- © 2011 Sparta Systems Inc. All Rights Reserved 1 Introduction 1.1 Purpose This document summaries the content of the TrackWise 8 IQ/OQ Validation Package. This includes: 1) summary of the results of the execution of the Operation Qualification scripts; 2) deviation summary; and 3) plans for upgrades and changes to the Validation Package. 2 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:

TrackWise 8.3 Validation Summary Report 8 of 18 -Information contained in this document is confidential and proprietary- © 2011 Sparta Systems Inc. All Rights Reserved ‘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. 3 Products Tested Applications that were tested as part of this effort include the following: TrackWise Web Admin TrackWise Coordinator TrackWise Migrator TrackWise Integration Manager Selection Import Utility PR Import Utility Person Import Utility Entity Import Utility LDAP Synchronizer Multiple Language Update Utility Full Text Admin Utility MedDRA Import Utility Sparta Systems, Inc. Test Case Title Page

TrackWise 8.3 Validation Summary Report 9 of 18 -Information contained in this document is confidential and proprietary- © 2011 Sparta Systems Inc. All Rights Reserved TrackWise Web TeamAccess 3.1 Build Dates Build dates for TrackWise 8.3 is included in the Build Listing located on the TrackWise DVD. 3.2 Release Content The content of this release is specified in TrackWise 7.0 FRS, the TrackWise 7.0 FRS Addendum, and the TrackWise FRS 8.3 Addendum. 4 TrackWise IQ/OQ Validation Package Listing

Identifier Description

n/a TrackWise 8 Validation Plan

n/a TrackWise 8 Risk Assessment

n/a TrackWise 7.0 Functional Requirements Specification

n/a TrackWise 7.0 Functional Requirements Specification Addendum

n/a TrackWise 8.3 Functional Requirements Specification Addendum

n/a TrackWise 8.3 Traceability Matrix

n/a SOP - TrackWise Administration

n/a SOP - TrackWise Configuration

n/a TrackWise 8.3 Validation Summary Report (this document)

n/a TrackWise 8 Installation Qualification Protocol

IQ-01 Installation DVD Verification

IQ-02 Database Installation Verification

IQ-03 TrackWise Installation Verification

IQ-04 TrackWise TeamAccess Installation Verification

IQ-05 TrackWise Web Admin Installation Verification

IQ-06 This number was intentional skipped.

IQ-07 TrackWise Crystal Reports Installation Verification

IQ-08 TrackWise 8.0 Upgrade Installation Verification

n/a TrackWise 8.0 Operational Qualification Protocol OQ-AEP-001 Audit Manager OQ-AEP-002 Audit Manager - Observations and Audit Record Composition OQ-AEP-003 Audit Records OQ-ER-001 E-Reporting - eMDR Mapping & Configuration OQ-ER-002 E-Reporting - eMDR Export & Processing OQ-ER-003 E-Reporting - E2B Mapping & Configuration OQ-ER-004 E-Reporting - E2B Export & Processing OQ-ER-005 E-Reporting - eMDV Mapping & Configuration OQ-ER-006 E-Reporting - EMDV Export & Processing OQ-ER-007 E-Reporting - CTR Mapping & Configuration OQ-ER-008 E-Reporting - CTR Export & Processing OQ-IM-001 Selection Import Utility Execution Mode OQ-IM-002 Selection Import Utility Service Mode OQ-IM-003 Import Translated Selection Values OQ-IM-004 Entity Import Utility Execution Mode OQ-IM-005 Entity Import Utility Service Mode OQ-IM-006 Person Import Utility OQ-IM-007 PR Import Utility Execution Mode OQ-IM-008 PR Import Utility Service Mode OQ-LDAP-001 LDAP Synchronizer Configuration OQ-LDAP-002 LDAP Synchronizer Execution OQ-MIG_8.0-001 Configuration Migrator - Migration Process OQ-MIG_8.0-002 Configuration Migrator - System Migration OQ-MIG_8.0-003 Configuration Migrator - Process Group Migration OQ-MIG_8.0-004 Configuration Migrator - Selection Values Migration OQ-SP-001 SharePoint Integration - Administration OQ-SP-002 SharePoint Integration - Execution OQ-SP-003 SharePoint Integration - Coordinator OQ-SP-004 SharePoint Integration - Configuration Migrator OQ-TA-001 System Flags OQ-TA-002 User Roles OQ-TA-003 Desktop Layout OQ-TA-004 Dashboards Sparta Systems, Inc. Test Case Title Page

TrackWise 8.3 Validation Summary Report 11 of 18 -Information contained in this document is confidential and proprietary- © 2011 Sparta Systems Inc. All Rights Reserved Identifier Description OQ-TA-005 Login Account Attributes OQ-TA-006 Desktop Search Classes OQ-TA-007 Group Category Permissions OQ-TA-008 Virtual Group Category Settings OQ-TA-009 Required Field Classes OQ-TA-010 Lock Field Classes OQ-TA-011 Clear Value Classes OQ-TA-012 Default Value Classes OQ-TA-013 Dependent Date Field Classes OQ-TA-014 Create Children Classes OQ-TA-015 Concatenated Field Classes OQ-TA-016 Project Specific Settings OQ-TA-017 Project Membership Settings OQ-TA-018 Notifications OQ-TA-019 Data Field Attributes OQ-TA-020 Reverse Field Dependencies OQ-TA-021 Dependent Fields OQ-TA-022 Ref. Record Field Behavior OQ-TA-023 Questions Field Behavior OQ-TA-024 Person Filter Classes OQ-TA-025 External Fields OQ-TA-026 TrackWise Reports OQ-TA-027 TrackWise Systems OQ-TA-028 User's Settings OQ-TA-029 Monitor Users OQ-TA-030 Monitor Locks OQ-TA-031 SpellCheck Settings OQ-TA-032 HelpDesk OQ-TA-033 Mail Merge OQ-TA-034 Mail Merge - All Desktop Items OQ-TA-035 Person Records OQ-TA-036 Entity Records OQ-TA-037 ConfigForm Administration OQ-TA-038 Batch Edit OQ-TA-039 Controlled Printing OQ-TA-040 User Authentication Attempts OQ-TA-041 MedDRA OQ-TA-043 Desktop Views OQ-TA-044 Scope Administration OQ-TA-045 Proxy Feature

TrackWise 8.3 Validation Summary Report 12 of 18 -Information contained in this document is confidential and proprietary- © 2011 Sparta Systems Inc. All Rights Reserved Identifier Description OQ-TA-046 InTray OQ-TA-047 Rich Text OQ-TA-048 Browser Detection OQ-TA-049 Calculated Number OQ-TA-051 Grid Field Behavior - Basic Functionality OQ-TA-052 Grid Field Behavior - Dependent Fields OQ-TA-053 Grid Field Behavior - External Fields OQ-TA-054 Grid Field Behavior OQ-TA-055 Person and Entity Field Behavior OQ-TA-056 FlexField Behavior OQ-TA-057 Anonymous PR Creation - Classes OQ-TA-058 Anonymous PR Creation - Execution OQ-TA-059 User Roles OQ-TA-060 Project Membership Settings OQ-TA-061 Selection Field Behavior OQ-TA-062 Auto Number Field Behavior OQ-TA-063 Person and Entity Field Behavior OQ-TA-064 Workflow Execution - Standard Functionality OQ-TA-065 Workflow Execution - Tasks OQ-TA-066 Workflow Execution - Project Changing Activities OQ-TA-067 Workflow Execution OQ-TA-068 Queries - Query Administration OQ-TA-070 Queries - Ad Hoc Query Builder OQ-TA-071 Queries - Text Queries OQ-TA-072 Queries - Charting OQ-TA-073 Queries OQ-TA-074 Calculated Date Fields OQ-TA-075 Child Tree Display Classes OQ-TA-076 Multi Text Field Behavior OQ-TA-077 Conditionally Required Fields Classes OQ-TA-078 External File Storage OQ-TA-079 Display Environment Name OQ-TA-080 Translate Terms OQ-TA-081 Translate Terms on ConfigForm Tabs, Section Names and Instructions OQ-TA-082 Translate Audit Manager Interface OQ-TA-083 Translate Terms - Import-Export OQ-TA-084 Translate Terms - Web Admin OQ-TA-085 Translate Terms - TeamAccess OQ-TA-086 Multiple Language Spell Check OQ-TM-001 Training Requirement Field Types

TrackWise 8.3 Validation Summary Report 13 of 18 -Information contained in this document is confidential and proprietary- © 2011 Sparta Systems Inc. All Rights Reserved Identifier Description OQ-TM-002 Training Manager - Administration OQ-TM-003 Training Manager - Execution OQ-TM-004 Training Manager - PR Import Functionality OQ-TM-005 Training Manager - TrackWise Coordinator Functionality OQ-TM-006 Searching Training Requirements and Curriculum OQ-TM-007 Training Manager - Force Training OQ-TM-008 Training Manager - Copy to Child OQ-TM-009 Training Manager - Training Req Fields in Ref Record Search Class OQ-TM-010 Training Manager - Support Different Administrative Levels OQ-TWC-001 Admin Scope OQ-TWC-002 Admin Schedules OQ-TWC-003 Admin Activity Configuration OQ-TWC-004 Admin Activity - Create PRs OQ-TWC-005 Admin Activity - Selection Values OQ-TWC-006 Admin Activity - Set Date Values OQ-TWC-007 Admin Activity - Set Person Values OQ-TWC-008 Admin Activity - Post Activities OQ-TWC-009 AutoExport Configuration OQ-TWC-010 AutoReport Configuration OQ-TWC-011 Admin Triggers and Dynamic Queries OQ-TWC-012 Admin Activities - Multiple Actions OQ-TWC-013 Admin Queries OQ-TWC-014 Coordinator Execution - Manual Mode OQ-TWC-015 Coordinator Execution - Service Mode OQ-TWC-016 Coordinator Execution - Multiple Instances OQ-TWC-017 Admin Query Log OQ-TWC-018 Cleanup Admin Activities OQ-TWC-019 End of Month OQ-TWC-020 Admin Activity - Set Other Fields OQ-TWC-021 Copy Parent ID in Create PRs OQ-WA-001 Initial Web Administrator Module Login OQ-WA-002 Person and Entity Record Creation OQ-WA-003 User's Settings OQ-WA-004 Terminology - System Fields OQ-WA-005 Terminology - User Defined Fields OQ-WA-006 Terminology - Dependent Fields OQ-WA-007 Terminology - Reverse Field Dependencies OQ-WA-008 Terminology - Ref. Record Field Administration OQ-WA-009 Terminology - Question Fields OQ-WA-010 Terminology - Documentum Object Field Type

TrackWise 8.3 Validation Summary Report 14 of 18 -Information contained in this document is confidential and proprietary- © 2011 Sparta Systems Inc. All Rights Reserved Identifier Description OQ-WA-011 Terminology - LiveLink Object Field Type OQ-WA-012 Default Meaning For Updates OQ-WA-013 Desktop Layouts OQ-WA-014 Audit Trail Activity Types OQ-WA-015 Activity Types OQ-WA-016 Activity Type Selection Value Classes OQ-WA-017 State Administration OQ-WA-018 Group Categories OQ-WA-019 Required Field Classes OQ-WA-020 Default Value Classes OQ-WA-021 Lock Field Classes OQ-WA-022 Clear Value Classes OQ-WA-023 Create Children Classes OQ-WA-024 Dependent Date Field Classes OQ-WA-025 Report Classes OQ-WA-026 Notification Classes OQ-WA-027 Person Field VGC Classes OQ-WA-028 Concatenated Field Classes OQ-WA-029 Notification Templates OQ-WA-030 Desktop Search Classes OQ-WA-031 Dashboard Classes OQ-WA-032 Person Filter Classes OQ-WA-033 Project Administration OQ-WA-034 Parallel State Machine OQ-WA-035 Task Sets OQ-WA-036 Project Changing Activities OQ-WA-037 User Roles OQ-WA-038 Login Accounts OQ-WA-039 Local Login Admin OQ-WA-040 Local Project Admin OQ-WA-041 Notification By Name OQ-WA-042 System Flags - General OQ-WA-043 System Flags - Authentication OQ-WA-044 System Flags - PR Related OQ-WA-047 Windows Authentication OQ-WA-048 Admin Messages OQ-WA-049 Admin Audit Trail History OQ-WA-050 Monitor Users OQ-WA-051 Monitor Locks OQ-WA-052 Logoff Request Notification Admins

TrackWise 8.3 Validation Summary Report 15 of 18 -Information contained in this document is confidential and proprietary- © 2011 Sparta Systems Inc. All Rights Reserved Identifier Description OQ-WA-053 Re-Assign Scheduled Activities OQ-WA-054 External Connections OQ-WA-055 External Fields OQ-WA-056 LDAP Authentication - Non-Anonymous Connection OQ-WA-057 LDAP Authentication - Anonymous Connection OQ-WA-058 Calculated Date Classes OQ-WA-059 User Authentication Attempts OQ-WA-060 Child Tree Display Classes OQ-WA-061 Conditionally Required Fields Classes OQ-WA-062 Auto Number Fields OQ-WA-063 External File Storage 5 Regression Testing The content of this release was not a full release, but did include regression testing on areas affected by changes. The tests that were executed are listed here. OQ-ER-006 OQ-ER-008 OQ-IM-005 OQ-TA-001 OQ-TA-005 OQ-TA-028 OQ-TA-056 OQ-TA-059 OQ-TA-064 OQ-TA-078 OQ-TA-080 OQ-TA-085 OQ-TM-003 OQ-WA-002 OQ-WA-003 OQ-WA-013 OQ-WA-036 OQ-WA-037 OQ-WA-038 OQ-WA-041 OQ-WA-043 Sparta Systems, Inc. Test Case Title Page

TrackWise 8.3 Validation Summary Report 16 of 18 -Information contained in this document is confidential and proprietary- © 2011 Sparta Systems Inc. All Rights Reserved OQ-WA-044 OQ-WA-048 OQ-WA-059 OQ-WA-063 6 Deviation Summary 6.1 Previous Deviations Deviations from previous execution of the Operational Qualification scripts for the enhancements to the TrackWise product at Sparta Systems, Inc. are identified in the following table. The description and status of each of these deviations are identified in the following table. TWBase Description Status / Severity ID 13123 OQ-DCTM-004: Webadmin Project Detail Report missing Livelink, Documentum Opened/Low and Sharepoint sections 11997 OQ-DCTM-004: User is unable to delete a documentum document under certain Opened/Medium circumstances 12571 OQ-TA-046: In Tray - TrackWise error is displayed while trying to sort on certain Opened/ columns Medium 6.2 Current Deviations During the execution of the Operational Qualification scripts for the TrackWise 8.3 at Sparta Systems, Inc., the deviations in the following table were identified. Each of these deviations is in the process of being corrected by Sparta Systems in accordance with SOP-Operations-002 Configuration Management. As each deviation is corrected, it will be reflected in future updates to this document. TWBase Description OQ Script Step(s) ID 12893 Unable to Delete Audit Trail Activity Types when they are not OQ-MIG-002 3 associated with any fields. 11013 Training Manager: searching for Requirements/Curriculums TM-006 29, 30, 39, 40, results in an error when using apostrophe 41, 42, 43, 44 11934 Admin: Create Children Class duplicate or Copy process group WA-023 10, 11 does not copy create children class state information

TrackWise 8.3 Validation Summary Report 17 of 18 -Information contained in this document is confidential and proprietary- © 2011 Sparta Systems Inc. All Rights Reserved TWBase Description OQ Script Step(s) ID 12716 "Projects" (or "Record Types") and "Division" displayed in TA-084 5, 24, 27, 28, 37, WebAdmin Tree nodes should be translated by using the terms 39, 144, 156, 161 translated in Translate Term, but not by "Field Name - Customized" of both data fields in WebAdmin. Another example location of where translations are not appearing is where datafield names are used in WebAdmin. For example, if you look at the Entities screen in WebAdmin and then choose Expanded View, some columns are translated but others like Territory, Sales Person, Account Manager, Entity Type, Customer ID, Date Customer, and Date Expired... are not translated. 13725 TW not obeying user setting for Date/Time on screens/reports TA-028 4, 5, 6, 7 13726 Additional Notes FlexField not behaving as expected for TA-056 61,65 continuously scrolling text and tables 13727 Translate Terms - Duplicate Entries are not reported in Report TA-080 16 Duplicated Translated Terms under File Menu 13728 Login Account Details (Project Membership) Configuration WA-038 56 Report displays incorrect Count of Active Login Accounts 13729 The System Flags Configuration Reports lists flags that have 6 WA-043 been removed from the System Flags screen 13730 System Flags Configuration Report not pulling data for "Days WA-044 4 Date Due from Date Due Parent" & "PR Acronym" 13738 Search is not behaving according to expected for Training TM-006 11, 40 Requirements and Training Curriculum 7 Test Summary and Certification Operational Qualification Scripts executed by Sparta Systems were all completed in a controlled environment that satisfies the current TrackWise System Requirements. Operational Qualification testing conducted was based on the TrackWise 8.3 release in accordance with the OQ scripts specified in section TrackWise IQ/OQ Validation Package Listing. TrackWise 8.3 with the build dates identified in section Build Dates has satisfied the acceptance criteria specified in the TrackWise Validation Plan and has been authorized to be released to customers. Each customer must assess the impact of open deviations versus their specific configuration. For use within a production environment, a formal Performance Qualification by the customer should be performed based on specific user requirements and physical environments.