About the President, Nancy George

Past United States Chairman,  USA ISO/IEC JTCT1/SC7 Technical Advisory Group, Logicon

"… I found Ms. George [President SQM] to be knowledgeable about all aspects of software development, in particular, as applied to the specialized needs of the medical industry. Ms. George recognized the importance of software engineering standards and the role that these standards will play in the emerging use of software in the medical field. The technical requirements contained in the [Software] Life Cycle standard [ISO/IEC 12207] as developed by Ms. George and other international software engineering experts will benefit all users in setting a common terminology and process for developing our future software systems. The adoption of this international standard will promote free trade amongst all nations and will make it easier to achieve common certification requirements for critical software applications such as in the medical industry. Ms. George is highly respected by United States and international technical experts who worked with her. As the past United States chairman for the international software engineering activities, I was able to see Ms. George work effectively with each of the technical experts in the field of software engineering. I therefore can record, through this letter, my highest regard for Ms. George and offer all those who read this letter my strongest recommendation for Ms. George’s capabilities..."

Kleinfeld, Kaplan and Becker Law Firm

We highly recommend Nancy George as an independent expert consultant in the field of software development and good manufacturing practices (GMPs) for computerized medical products. We have worked with Ms. George closely on issues involving the application of the U.S. Food and Drug Administration’s GMP regulations to the development and manufacture of sophisticated hardware and software for use as medical devices.

During our working relationship, Ms. George provided consistently sound advice regarding appropriate software development practices and GMPs for computerized devices. For Example:

  • She promptly identified key deficiencies in existing software development and manufacturing procedures, and recommended appropriate solutions.

  • She recommended thorough, practical corrective actions to upgrade development and manufacturing procedures, consistent with GMP requirements and good quality assurance practices.

  • She advised senior management on how to identify and solve emerging problems with existing products, and how to prevent problems from arising in products under development.

  • She significantly assisted in preparing for successfully completing FDA inspections.

We found Ms. George’s advice to be always thoughtful and well-considered. Her manner was helpful and tactful, even as she was firm in stating her views. We believe that her expertise, dedication, and diligence in pursuing practical solutions to problems would benefit any medical device or pharmaceutical company that requires advice relating to software and computer systems development...

Software Quality Management, Inc. (SQM), 2 Southerly Court, Suite 603, Towson, MD, 21286, USA, 410-339-5307 (v), 

410-823-8019 (f), info@sqminc.com, copyright SQM, 1997-2002, Last modified: November 18, 2009