Compliance services for ISO and
FDA regulations since 1994

Contact Us

Call Tim Stein at 1-408-768-7538

Proving Quality Services Since 1994

Business Performance Associates, Inc., located in the San Francisco area, was founded in 1994. We have served over 130 large and small clients.

Our approach

We work to understand your needs and select a consulting approach that will work in your situation.

In our compliance consulting, we build on your current practices, find practical, value-added ways to close compliance gaps and collaborate with you in establishing the solution. This approach is built upon the three fundamental requirements for creating improvements:

  • A clear vision of what is to be accomplished
  • Proven method that will reduce risk and ensure success
  • The collaboration of end-users to ensure buy-in

These three conditions are created through sound project management.

All of our consultants are subject matter experts with extensive business and consulting experience.

Please contact us so that we might begin to collaborate with you to assist in your success.

Executive Team

Tim Stein, Ph.D.
Founder and President

Tim founded Business Performance Associates, Inc. in 1994. Since then, he has personally consulted with over 100 companies; the majority of them are in regulated industries. Tim's major service areas include: software regulatory compliance, regulatory submissions for software, the development of quality systems, and computer system validation.

Tim frequently plays the role of bringing together engineering and regulatory compliance. With an understanding of both, Tim is able to assist in implementing product development processes that both build on existing engineering practices and are compliant. He works with the development team, especially software developers, to produce, during the development process, the documentation that is needed for submissions.

Tim served as the Director of Software Validation and Quality Assurance at Genomic Health. Prior to founding BPA, he was the director of product development for a TQM consulting company.

Tim is the author of the highly regarded volume on software validation entitled: The Computer System Risk Management and Validation Lifecycle, Paton Press, 2006.

Tim is a frequent speaker on local and national levels on topics related to software regulatory compliance, software validation, and quality systems. To review highlights of the over 40 public presentations that Tim made over the past decade, see the BPA Publications and Presentations page. Tim is a Fellow of the American Society for Quality, and served on the leadership team of the Northern California Biomedical Discussion Group for seven years.

Visha Stein
Vice President

Ms. Visha Stein has over 30 years of experience in creating, implementing, improving, managing, and auditing Quality Management Systems across a wide range of industries like electronics, chemicals, foods, metals, plastics, and FDA regulated industries.

She has extensive experience in the medical device, biotech, combination products, and pharmaceutical industries creating systems in accordance with FDA and European regulations and international standards.

Visha has extensive experience auditing in over 100 industry segments as a lead auditor with Registrars and Notified Bodies. From this experience, she knows how an auditor from a certification body will interpret quality system requirements. She has seen effective business practices for various industries, and has experience in establishing and implementing compliant quality systems that will benefit your business.