Penny has worked as a compliance consultant since 1999. She has extensive experience writing user and functional requirements specifications, design specifications, test plans, IQ and OQ protocols. She has written complete software validation for a multitude of systems and clients of various sizes including a high risk 510K submittal. She has participated in development of evaluation and remediation plans to meet FDA CFR 21 Part 11 requirements and Sarbanes Oxley regulation. Penny has written SOP’s and DOP’s for quality assurance and regulatory compliance at both the corporate and divisional level. She understands GAMP Standards, ISO 9000 standards, GxP regulations, FDA guidelines and HIPAA (HITECH Act and Final Omnibus HIPAA rule) regulations as they apply to software validation. She is also familiar with developing controls and policy for Sarbanes Oxley adoption.
My objective is to assist companies reach their goals by applying my ability to quickly grasp project objectives and provide commonsense solutions.
My solid IT background is combined with years of working with FDA regulations, Sarbanes Oxley Controls, HIPAA and ISO regulations. This helps me to develop policy, procedures and software validations for my clients which will stand up to quality review without hindering business activities.
Penny Goss Technical Solutions