Lorrie Vuolo-Schuessler is the Senior Director of Computer Systems Quality and Data Integrity at Syneos Health. The Computer Systems Quality & Data Integrity team provides support and consultation to internal and external business partners to assist them in meeting global regulatory and data integrity requirements for computerized systems. CSQ conducts internal and external computer system audits and supports audits and regulatory inspections that focus on computer systems.
Lorrie received her BS in chemistry from the College of St. Elizabeth and her MS degree in biochemistry from New York Medical College.
Lorrie is a member of the Society of Quality Assurance (SQA), Mid-Atlantic Regional Society of Quality Assurance (MARSQA), and the International Society for Pharmaceutical Engineering (ISPE). Lorrie has been involved with ISPE and GAMP leadership since 2002. She is currently the Co-Chair of the GAMP Americas Steering Committee and a member of the GAMP Global leadership team. She has been driving the data integrity efforts within GAMP as the Co-Chair of the GAMP Data Integrity Special Interest Group (SIG) which recently completed the ISPE GAMP RDI Good Practice Guide: Data Integrity – Manufacturing Records. She also contributed to the development of the ISPE GAMP RDI Good Practice Guide: Data Integrity – Key Concepts, the ISPE GAMP Guide: Records and Data Integrity, and the GAMP Good Practice Guide: Global Information Systems Control and Compliance. Additionally, she served as the leader of the GAMP Laboratory Special Interest Group driving the development of the GAMP Good Practice Guide: Validation of Laboratory Computerized Systems V1 (2005) and subsequently the GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Systems Second Edition (2012).