Recent Projects   Medical device design house: collaborated with another software validation firm on plans and procedures for software validation for a therapeutic device. Evaluated regulatory assessment documents, reviewed detailed multipart requirements specification to identify testable elements, devised single traceability matrix, completely rewrote software function test, developed detailed error condition test. (December 2007 - January 2008; project to resume April 2008) Software vendor: Helping create documented software quality system. Started by framing Quality Manual based on ISO 13485. Assessing company’s software product to recommend 21 CFR Part 11 features (to enhance product’s appeal to pharmaceutical-company customers). Quality system project completed March 2008. Medical device consulting firm: Evaluated software quality procedures and software documentation for several different medical device clients. Assisted in explaining software development plans to FDA reviewers. (Various projects, 2005 - 2008.) Specialty fabrics manufacturer (vendor to multiple medical device companies): Validated twenty-one software applications employed in manufacturing, development, operations, and the quality system, as part of client's push toward ISO 13485 certification. Concluded March 2007; client earned ISO 13485 certification in May 2007. Lyophilization service: Validated software driving two production freeze-drying units, and developed procedure to demonstrate equivalence of data between software-driven data-logger and standalone PC software that reads data files from the datalogger. Validations completed September 2006.