Lisa Olson

Background

About Lisa Olson

I have a passion for the accuracy of computer system implementations, including ensuring the business and regulatory requirements are clearly and accurately defined, that the delivered system meets those requirements, as demonstrated via thorough testing, and ensuring that changes are managed to avoid impact (including the accurate forward migration of existing data). I also focus on system operational tasks (such as access control, system use, backup/recovery, incident tracking) to ensure they are addressed with the implementation processes, not just focusing solely on the software. Proficient in providing training to translate technical or regulatory topics for different audiences, to help them understand applicability and impact, and assisting with assessing risk with technology implementations, especially in the clinical trial environment. My detailed orientation makes me love editing documents for accuracy and consistency, and I am also very interested in usability testing, as I find that frequently products do not really address how people use them in “real life.” I use my strengths to help companies that are just starting out with computer system compliance, organizations new to the FDA-regulated industry, or vendors who are experiencing client audits for the first time.