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 is a member of the Society of Quality Assurance (SQA), SQA-Computer Validation and Information technology Compliance (CVIC), the CVIC- Data Integrity & Governance (DIG) subcommittee, the Audits & Vendor Assessments (AVA) subcommittee and the Mid-Atlantic Regional Society of Quality Assurance (MARSQA). Lorrie has been involved with International Society for Pharmaceutical Engineering (ISPE) and the GAMP Community of Practice leadership since 2002. She is currently 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 by Design. She also contributed to the development of the ISPE GAMP RDI Good Practice Guide: Data Integrity – Manufacturing Records, the ISPE GAMP RDI Good Practice Guide: Data Integrity – Key Concepts, and the ISPE GAMP Guide: Records and Data Integrity. 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).