Software Verification and Validation, What They Are and Aren’t

ABSTRACT

The FDA’s General Principles of Software Validation was first released 12 years ago, but there is still confusion about just what is meant by software validation and how it differs from system validation and software verification. This session will clarify the terminology and provide some insights into the regulatory intent behind validation.

ABOUT THE SPEAKER

David Vogel, Ph.D., President, Intertech Engineering Associates, Inc.

David Vogel, Ph.D. is the founder and president of Intertech Engineering Associates Inc., of Norwood, Massachusetts. Founded in 1982, Intertech has served the medical device industry by providing electronics hardware and software development services. Dr. Vogel and his Intertech engineering team have developed engineering processes that facilitate product design compliance with FDA Quality System Regulations (QSR). The product verification and validation services provided by Intertech have had a 100% safety record. Dr. Vogel received a BS in electrical engineering from M.I.T. He earned a master's degree in bioengineering, a master's degree in electrical and computer engineering, and a doctorate in biomedical engineering from the University of Michigan.

The Role of Risk Management in Software Validation

ABSTRACT

Design Validation (820.30(g)) requires risk analysis. This presentation will give an overview of the concepts and activities related to software risk analysis to better understand the goal behind software risk analysis and how it relates to the overall system risk analysis. The concept of “risk based” validation will be covered along with its advantages and the problems one might encounter trying to implement it. A brief case study on tracing 62304 safety classes into the quality system for risk based validation will be presented

ABOUT THE SPEAKERS

David Vogel, Ph.D., President, Intertech Engineering Associates, Inc.

David Vogel, Ph.D. is the founder and president of Intertech Engineering Associates Inc., of Norwood, Massachusetts. Founded in 1982, Intertech has served the medical device industry by providing electronics hardware and software development services. Dr. Vogel and his Intertech engineering team have developed engineering processes that facilitate product design compliance with FDA Quality System Regulations (QSR). The product verification and validation services provided by Intertech have had a 100% safety record. Dr. Vogel received a BS in electrical engineering from M.I.T. He earned a master's degree in bioengineering, a master's degree in electrical and computer engineering, and a doctorate in biomedical engineering from the University of Michigan.

Jeremy Jensen, CRM Compliance Consultant; CSQE, Boston Scientific, Cardiac Rhythm Management Inc.

Jeremy Jensen is a Compliance Consultant in the CRM Compliance group of Boston Scientific. He is an ASQ Certified Software Quality Engineer and has worked for and consulted with some of the top medical device manufacturers (e.g. St. Jude Medical, Guidant, Abbott Laboratories and Medtronic) on FDA regulated software engineering. Prior to Boston Scientific, he was president of Lumina Engineering, a Minnesota based Software Engineering consulting group specializing in FDA regulated software development and testing. Currently he responsible for establishing and maintaining effective structures to ensure consistent implementation of quality systems as it relates to regulated software at Boston Scientific CRM. He helps create and implement processes and process improvements to ensure consistent implementation of external regulated software laws, regulations, guidances and standards (LRGS).

Quality System Software Validation Production and Process Controls

ABSTRACT

Automated Systems (820.70(i)) requires validation of software used to automate internal processes that are part of the production or quality system. This presentation will describe a practical approach to planning and conducting validation of software that falls into the domain of 820.70(i). References will be made to FDA Guidance and TIR 36.

ABOUT THE SPEAKER

Denise Stearns, Sr. Director, Regulatory Affairs, StillRiver Systems, Inc.

Denise Stearns has worked in the medical device industry for 28 years in a variety of functions including Quality, Operations and Engineering. She has a technical and educational background in software, electrical engineering and quality assurance. For the last 13 years, she has been focused on the implementation of quality systems, particularly in the area of product and non-product software life cycle activities. She co-chaired the AAMI working group that developed TIR-036, "Validation of Software for Regulated Processes" that was published in 2007.

As a Corporate Director at Boston Scientific from 2002 through 2006, Denise defined and implemented the first controlled quality system elements for all non-product software corporate wide. This included IT systems with global quality system applications (Document Control, Complaints, CAPA), Clinical Trial Databases and Manufacturing Equipment software control systems and applications. She holds a Bachelor of Science degree in Computer Information Systems from Regis University with a minor in Business.

The last couple of years have been spent as the Sr. Director of Regulatory and Quality at a startup company called Still River Systems, Inc. In this role, she has led the definition and implementation of the overall quality system and is responsible for working with FDA to obtain clearance for the company''s first medical device. The complexity of this device led her to develop the use of Assurance Cases as a risk based approach to the Design History File and the FDA submission.

Assurance Cases

ABSTRACT

An Assurance Case is a tool that can be used to map medical device claims (like safe and effective) to Design History File data. In the case of safety claims, Assurance Cases can help organize the data in a risk based structure that can be used:

• To help guide regulatory reviewers to all the safety data
• To assist in evaluating the impact a changes to the DHF/DMR
• To assist in customer complaint investigations
• To help in any other risk based activity that requires the ability to relate harms/hazards with the risk control measures implemented in the device design, use controls and/or labeling.

ABOUT THE SPEAKER

Denise Stearns, Sr. Director, Regulatory Affairs, StillRiver Systems, Inc.

Denise Stearns has worked in the medical device industry for 28 years in a variety of functions including Quality, Operations and Engineering. She has a technical and educational background in software, electrical engineering and quality assurance. For the last 13 years, she has been focused on the implementation of quality systems, particularly in the area of product and non-product software life cycle activities. She co-chaired the AAMI working group that developed TIR-036, "Validation of Software for Regulated Processes" that was published in 2007.

As a Corporate Director at Boston Scientific from 2002 through 2006, Denise defined and implemented the first controlled quality system elements for all non-product software corporate wide. This included IT systems with global quality system applications (Document Control, Complaints, CAPA), Clinical Trial Databases and Manufacturing Equipment software control systems and applications. She holds a Bachelor of Science degree in Computer Information Systems from Regis University with a minor in Business.

The last couple of years have been spent as the Sr. Director of Regulatory and Quality at a startup company called Still River Systems, Inc. In this role, she has led the definition and implementation of the overall quality system and is responsible for working with FDA to obtain clearance for the company''s first medical device. The complexity of this device led her to develop the use of Assurance Cases as a risk based approach to the Design History File and the FDA submission.

Driving Software Laws, Regulations, Guidances, and Standards into your Quality System

ABSTRACT

There is a plethora of software related laws, regulations, guidances and standards (LRGS) that are pertinent to the Quality System of your Medical Device company. This presentation will indicate which software LRGS’s are imperative to institutionalize into your Quality System to reduce FDA or Notified Body compliance risk. Discussion will include a high level implementation strategy to driving these LRGS’s down into processes and procedures pertinent to software validation.

ABOUT THE SPEAKER

Jeremy Jensen, CRM Compliance Consultant; CSQE, Boston Scientific, Cardiac Rhythm Management Inc.

Jeremy Jensen is a Compliance Consultant in the CRM Compliance group of Boston Scientific. He is an ASQ Certified Software Quality Engineer and has worked for and consulted with some of the top medical device manufacturers (e.g. St. Jude Medical, Guidant, Abbott Laboratories and Medtronic) on FDA regulated software engineering. Prior to Boston Scientific, he was president of Lumina Engineering, a Minnesota based Software Engineering consulting group specializing in FDA regulated software development and testing. Currently he responsible for establishing and maintaining effective structures to ensure consistent implementation of quality systems as it relates to regulated software at Boston Scientific CRM. He helps create and implement processes and process improvements to ensure consistent implementation of external regulated software laws, regulations, guidances and standards (LRGS).

Roundtable Discussion on Current Topics in Software Validation

ABSTRACT

This is an open forum for questions about current topics. Current FDA initiatives related to software such as Healthcare Information Technology (HIT), Device Interoperability, and standards/TIR activity related to 800001, and Agile Methods may be discussed in addition to whatever topics are raised from the floor.