I audited several projects and identified several areas of potential regulatory exposure. I also provided staff with tailored training in software development and software validation.

I helped plan and implement a database migration stragegy to move a terabyte database from Sybase to Oracle. I planned and oversaw the validation strategy that ensured the integrity of the migration process and the accuracy of the data post-migration

I reviewed the software development processes used by the IT Staff in developing software for running the business. As a result of this review, I developed a custom on-site training session that focused on writing and reviewing requirements, peer reviews, and testing against requirements. I also provided training for sr. executives on the importance of having a Predictable Software Development™ process.

I performed an assessment of the software development practices used by the IT Staff in developing software for manufacturing. As a result of this assessment, I provided an on-site training session in software development for medical device manufacturers, provided training in basic software validation practices, provided training in work flow diagrams for manufacturing staff, and wrote test procedures based on revised SOPs that incoroporated work flow diagrams.

I performed a due diligence audit as part of an acquisition. Working with the acquiring company's attorneys, I provided a factual assessment of the state of the company being considered for acquisition with regard to compliance with relevant FDA regulations and guidance documents.

I provided examples of standard operating procedures in key areas needed for FDA compliance. Working with the staff, I helped tailor these SOPs to reflect how tasks were peformed. The results proved to be very benefical in helping to get these companies off in the right direction.

I provided guidance on developing software for a blood bank application. This included working with the Project Team to develop an more realistic set of SOPs, on-site training for the Test Team, and mentoring and coaching for the QA Team. In addition, I helped the QA Team perform more effective internal audits, and helped the organization prepare for and respond to an FDA Inspection.

I provided a plan for ensuring data integrity during the process of migrating terabyte databases from Sybase to Oracle. I also provided on-site training in several areas including testing, configuration management, risk management, and, project management.

I provided guidance in how to perform Software Validation. On several different projects, I acted as the Software QA Lead and prepared the Test Plan, wrote many test scripts, and was actively involved in executing tests, reporting defects, and performing regression testing.

This company was struggling with ways to define requirements for a new product that was desperately needed. As is typical, they had lots of clinical expertise but little software development skills. To address this, I showed them how to use Use Cases to define user requirements in a manner that was based on actual user workflow. The Use Case diagrams were then used as the basis for developing the requirements and validation tests.

I provided them with assistance in understanding the FDA requirements for software development and in performing a Risk Analysis for a new product.