Touchstone Technologies, Inc.

One of Life Sciences Industry’s Leading Data Integrity Experts • Helped FDA write original Data Integrity regulation used both domestically and internationally. • Leading Expert in FDA regulations – worked on “both sides of the table”. • Worked with US Government and European Governments to define Data Integrity regulations. • Worked with Big 20 and SMB companies. • Member of LifeSciences Think Tank to drive Data Integrity best practices for LifeSciences industry. • Co-authored Data Integrity Book for Society of Quality Assurance (SQA) in 2022 • Co-authored Computerized Systems for Clinical Research with FDA and Drug Information Association (DIA) in 2011 • Co-authored 21 CFR 11 regulation and General Principles of Software Validation guidance with FDA and industry. • Commenting on Data Integrity Guidance Documents for Industry • Interviewed by Wall Street Journal (WSJ), European Biopharmaceutical Review, Healthcare Packaging • Services include: o Audits o Submissions o Inspection readiness setup and inspection support o Set up of Systems and processes (SOPs). o Quality Management Systems (QMS) o Vendor Selection, Contract and Management o Risk and Risk Management o Program and Project Management o Remediation following adverse inspectional or audit findings. o Assistance in prosecution / defense o Training o Law firms: Data Integrity for:  Arbitration  Expert Witness • Clients include: o LifeSciences industry Pharma, Biotech, Medical Devices o Gene Therapy companies o Vendors o Investors for LifeSciences companies o Big 4 e.g., PriceWaterhouseCoopers • National and International Speaker and Trainer • Adjunct Professor at UC Berkeley