Our February, 2009 meeting will be held on Tuesday, Feb. 24th at 6:00PM. Please RSVP to news@ssq.org.

Topic

Risk Assessing Requirements to Control and Measure Systems Success

Vimarie Ortiz, Operational Partner, Processo Partners, Inc.

This presentation is designed to provide fundamental knowledge and practical skills to anyone interested in implementing or improving computer systems requirements’ risk assessment techniques and practices in their organizations. This presentation introduces requirements’ risk management as the basis to provide customers and users the system they need, and control implementation scope, time and efforts.

The presentation starts with an overview of the gathering of requirements and some elicitation tools per requirement type. Straightforward requirements’ risk assessment and prioritization techniques are discussed, to arrive at the use of requirements’ risk levels as the CAP to implementation scope and effort.

Presentation attendees will learn how to:

• Plan requirements elicitation
• Apply simple risk management practices to requirements
• Assess best risk mitigation tools to use
• Manage risk information and track risks
• Use risk levels to:
• Define system implementation priorities
• Direct implementation efforts

Intended Audience

Software quality engineers, project and functional managers, functional analysts, validation consultants, software quality assurance, and other software stakeholders who will be involved in planning and participating in requirements gathering and system implementation planning.

Industry References

This presentation introduces risk management and requirement gathering principles discussed in Managing Risk: Methods for Software Systems Development, Elaine M. Hall, Addison-Wesley, Reading Massachusetts, 1998; FDA: 2002 Guide for Validation of Automated Systems; IEEE/EIA:12207.1-1997 Guide for Information Technology: Software Life Cycle Processes 12207.1-1997; ISO 14971:2000, Medical Devices – Application of Risk Management to Medical Devices; Processo’s acquired experience and practices implementing and validating computerized systems in the life sciences industry.

About Our Speaker

Vimarie Ortiz is a principal with Processo Partners, Inc., a consulting software quality company in South Florida specializing in all aspects of Software Quality and Computer Systems Validation.

Ms. Ortiz’s experience in the software development, medical devices, biotechnology, and pharmaceutical industry spans a decade, assisting customers in the assessment, support, and management of computerized systems implementations, and the design of validation solutions using SW Quality Engineering, Risk Management, Lean Software Development, GAMP, and Configuration Management approaches. She is actively involved in the dissemination of software quality awareness and best practices through trainings, workshops and coaching worldwide.

For more information visit Processo Partners’ website at www.processopartners.com, or by email to vortiz@processopartners.com.

Meeting Details

Date

Tuesday, February 24th, 2009 at 6:00PM

RSVP:

news@ssq.org

Cost (Including Dinner):

Members: $8.00
Students: $8:00
First-time guests: $8.00
Non-members: $15.00

Location:

Cardinal Health
(C1-A306)
6055 Lusk Blvd
San Diego CA 92121

From Lusk Blvd turn right at first driveway. Turn left at the roundabout. Drive around to the back of the building and park. The conference room is located at the rear of the bldg. and is accessible from the parking lot.

View Larger Map