Manager, Quality Assurance s1

Standard Operating Procedure: TrackWise 8 Configuration

Document Version 1.00

December 2010

/ Document Version 1.00/ December 2010

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.
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/ Sparta Systems Europe, Ltd.
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+852.2376.9345

Sparta Systems, Inc. / Test Case Title / Page
Standard Operating Procedure - TrackWise 8 Configuration / 14 of 14

-Information contained in this document is confidential and proprietary-

/ Document Version 1.00/ December 2010

Contents

1 Purpose 6

2 References 6

3 Responsibilities 6

4 Abbreviations, Acronyms and Definitions 6

5 Procedures 8

5.1 Configuration 8

5.2 Testing of Development Environment Configuration 10

5.3 Configuration Migration from Development to Validation Environment 11

5.4 Testing of Validation Environment Configuration 11

5.5 Configuration Migration from Validation to Production Environment 11

5.6 Change Management 11

6 Attachments 13

Sparta Systems, Inc. / Test Case Title / Page
Standard Operating Procedure - TrackWise 8 Configuration / 14 of 14

-Information contained in this document is confidential and proprietary-

/ Document Version 1.00/ December 2010

Document Review and Approval

Prepared By:

Garry Heon
Director, Quality
Name / Title / Signature / Date

Reviewed and Approved By:

Marina Aslanyan
Vice President, Solutions Delivery & Support
Name / Title / Signature / Date
Sparta Systems, Inc. / Test Case Title / Page
Standard Operating Procedure - TrackWise 8 Configuration / 14 of 14

-Information contained in this document is confidential and proprietary-

/ Document Version 1.00/ December 2010

Document History

Version / Supersedes / Effective Date / Summary of Changes / Justifications /
1.00 / n/a / December 2010 / Initial Release
Sparta Systems, Inc. / Test Case Title / Page
Standard Operating Procedure - TrackWise 8 Configuration / 14 of 14

-Information contained in this document is confidential and proprietary-

/ Document Version 1.00/ December 2010

1 Purpose

The purpose of this Standard Operating Procedures (SOP) is to outline the tasks and responsibilities required for configuring the TrackWise application.

2 References

Below is a list of the external documents specific to this SOP:

Document / Title /
Change Control SOP / An approved corporate change control Standard Operating Procedure developed by the client to control changes to, or implementation of, new applications.

3 Responsibilities

Role / Responsibilities /
Business Owner / Responsible for all configuration parameter changes, workflow changes, and participating in all implementation activities.
Developer / Responsible for providing specific support, development, or test activities, documentation, assessment, or other services required on a case by case basis for each configuration parameter.
Product Specialist / Team member designated to be the TrackWise® application subject matter expert.
Project Administration / Responsible for maintaining changes to project configurations and workflows.
Quality Control / Responsible for ensuring corporate methodologies/SOPs are followed during system implementation.
User / Responsible for providing specific support, test activities, documentation or other services required on a case by case basis for each configuration parameter.
Validation / Responsible for assisting in determining the validation strategy for system implementation.

4 Abbreviations, Acronyms and Definitions

Below is a list of the abbreviations, acronyms, and definitions specific to this SOP:

Abbreviation, Acronym, Definition / Explanation /
Activity / Contains the information of a particular action that was performed, or is scheduled to be performed, on behalf of a particular PR.
CAPA / Corrective and Preventive Action - When Deviations, Nonconformance, Out of Specifications, Incidents or Complaints occur, or when developing trends trigger the need for change, Corrective and Preventive Actions (CAPA) need to be implemented.
ConfigForms™ / Provides the ability to configure PR detail screens, which allows the TrackWise® administrator to create unique screen layouts and views for different groups or projects.
E-Signature / Electronic Signature – A computer data compilation of any symbol or series of symbols executed, adopted or authorized by an individual to be the legally binding equivalent of the individuals hand written signature.
Group Category / A given set of permissions defined for the purpose of classifying a group of users.
Migrator™ / A web-based application that is designed specifically to copy configuration and admin audit trail data between two databases.
PR / Product Request – Is the default name for a record within the TrackWise® system.
Project / A placeholder for a group of PR’s that share the same workflow, business rules, and common users.
SnagIt / Commercially available screen capture utility not included in TrackWise®.
State / The current status of a PR in conjunction with its workflow. The state denotes the status of the PR is the state-machine that defines the workflow of a group of users.
State-Machine / Mechanism used to define workflow for a given group category.
System Field / A data field that is present with the initial configuration of the system.
TrackWise® / Suite of products designed to handle a variety of different tracking applications, such as Deviations, Complaints, CAPAs, Audit/Observations, Change Control, and other related issues.
TrackWise Administrator ™ / Allows the TrackWise® administrator to set-up, configure, maintain, and make changes to the system
Virtual Group Categories / Provides different degrees of user authorization relative to their responsibilities or role for a particular PR’s within a given project.

5 Procedures

5.1 Configuration

1. The Product Specialist will initiate the creation of the quality control documentation associated with the configuration. At a minimum, the documentation will consist of Microsoft Visio workflows and Excel spreadsheets that capture key configuration requirements as detailed below. In addition, product support should use screen captures of each ConfigForms™.

2. The Microsoft Visio documentation is used to develop the workflows and should consist of the following information:

§ Project Administration helps integrate previously configured components into a working system. Projects are defined within each Division, Group Categories are linked to Projects and other Project-specific settings are determined. An overview page with the Division / Project breakdown of the project as a whole should be documented.

§ At least one page for each approved configured workflow should be included, containing a graphical representation of the following:

a. States

b. Activities

c. Group category definitions and delineations

d. Notification rules

e. E-Signature requirements

f. State attributes (locked, protected, closed)

g. Virtual Group Category settings

h. Parallel Task activities, required or optional, for that Task Set

i. Project-changing activities.

§ A legend page explaining the definitions of each TrackWise® “object” brought forth throughout that particular Visio document (e.g., rectangle = state, ellipse = activity) should be included.

3. A Microsoft Excel document should be used to compliment the Visio diagrams by including the following information:

§ A sheet detailing each of the following:

a. System fields

b. Customized names

c. User-defined fields

d. Field type

e. Which Projects each field is applicable to

f. All other relevant PR Field Attributes.

§ A sheet detailing each Selection and Multi-Selection type field’s applicable values. (Furthermore, if dependent fields are being used, a copy of the import flat-file attached).

§ A sheet detailing each Classification field; its related Project Category; all applicable values.

§ A sheet per Project detailing each Group Category’s view and edit permissions to each field, as well their Overall Permissions.

§ A sheet per Project detailing each Required Field class’s required fields by state.

§ A sheet detailing each field and its correlating Audit Trail Activity, if applicable.

§ A sheet per Project detailing each activities Notification rules, if applicable and associated Notification template.

§ A sheet detailing each Notification Template and the fields used / not used within it.

§ A sheet detailing each System Flag’s operational setting.

§ A sheet detailing each Web Applications servlet parameters.

§ A sheet per Desktop Layout listing each field (from left to right) used on it as well as any customized naming conventions.

§ A sheet detailing any Task Sets configured for parallel activities in a workflow with optional and mandatory activities.

§ A sheet detailing each State’s attributes.

§ A sheet detailing each Activity’s attributes.

§ A sheet detailing the TrackWise Coordinator ™ configuration which shall include the name and configuration behind each of the following:

a. Admin Query

b. Admin Scope

c. Admin Activity (including Notification and related Notification Templates)

d. Admin Schedule.

Furthermore the sheet will show the relationships defined within the configuration along with the Priority Group and configured Program Entry.

4. Screen captures of each ConfigForm may be collected using SnagIt or other mechanism in order to capture GUI configuration.

5. Other documents shall include, but are not limited to:

§ TrackWise Administrator ™ text reports

§ Crystal Reports “Admin Reports”

§ Oracle Database Connectivity parameters and settings

§ SPARTA.INI parameters and settings

§ Entity and Person import files

6. All configuration documentation will be maintained in accordance with company change control procedures.

7. Documentation will be reviewed by designated project team members for discrepancies, comments, and approvals.

8. The Business Owner shall review and approve the overall system configuration.

9. The configuration team shall review and approve the detailed configuration and workflow documentation.

5.2 Testing of Development Environment Configuration

Designated areas within an organization will develop configuration parameters on how they will be utilizing the TrackWise® application. The creation of these parameters will take place in a development environment. The following procedures will be followed to execute the testing of the development configuration prior to migration into Validation Environment.

1. Notify validation group that the configuration is complete in the development environment.

2. Execute approved configuration verification test script(s).

3. Obtain signatures from designated project team members assigned to approve the configuration test execution results.

4. Prepare change control documentation governing the release to the validation environment.

5.3 Configuration Migration from Development to Validation Environment

Designated areas within an organization will have developed and approved configuration parameters on how they will be utilizing the TrackWise® application. The creation of these parameters was created in a development environment will be verified in a validation environment. The following procedures will be followed to migrate the configuration of a development environment to a validation environment.

1. Using the Migrator application, migrate the source Development database to the destination Validation database.

2. Verify successful migration results by viewing the generated Migrator log file.

3. Obtain signatures from designated project team members assigned to approve the migration results.

5.4 Testing of Validation Environment Configuration

The following procedures will be followed to execute the testing/validation of the validation configuration prior to migration into production.

1. Notify validation group that the configuration is complete in the validation environment.

2. Execute approved configuration verification test script(s).

3. Obtain signatures from designated project team members assigned to approve the configuration test execution results.

4. Prepare change control documentation governing the release to the production environment.

5.5 Configuration Migration from Validation to Production Environment

Designated areas within an organization will have developed and approved configuration parameters on how they will be utilizing the TrackWise® application. The creation of these parameters was created in a development environment and verified in a validation environment. The following procedures will be followed to migrate the configuration of a validation environment to a production environment.

1. Using the Migrator application, migrate the source Validation database to the destination Production database.

2. Verify successful migration results by viewing the generated Migrator log file.

3. Obtain signatures from designated project team members assigned to approve the migration results.

5.6 Change Management

All changes to a computer system must be tracked and documented to the extent that at any point in the life of that computer system, the exact configuration of all components of the system may be identified. Changes to the TrackWise® configuration will be implemented according to the following procedures.

1. Document and submit a request for configuration change to business owner.

2. Follow procedures as outlined in approved corporate change control management SOP.

6 Attachments

Example of Process Workflow in Visio

Example of Configuration Table in Excel for Fields

Sparta Systems, Inc. / Test Case Title / Page
Standard Operating Procedure - TrackWise 8 Configuration / 14 of 14

-Information contained in this document is confidential and proprietary-