Case Study: Duke University Medical Center achieves paperless, streamlined GCLP audits with Ideagen's Q-Pulse mobile apps

Ideagen’s Q-Pulse mobile apps replace Duke University Medical Center’s paper processes during human clinical trials

Duke University Medical Center’s Central Quality Assurance Unit (CQAU) oversees immunogenicity testing for HIV vaccine trials and must maintain strict Good Clinical Laboratory Practice (GCLP) compliance across multiple labs. The team was burdened by around 300 paper SOPs and lengthy, paper-based audit checklists—an especially difficult problem in Biosafety Level 3 labs where paperwork is hard to manage and disinfect—creating heavy administrative overhead and slow audit workflows.

The CQAU implemented Ideagen’s Q-Pulse mobile apps (Q-Pulse Docs and Q-Pulse Audit) on tablets to replace paper processes. Staff can access SOPs on the move, complete audits digitally, raise non-conformances from the checklist, and avoid rekeying findings into the central system. The result was a major reduction in paperwork, faster audits, improved traceability, and safer, more efficient operations in BSL3 environments.

Duke University Medical Center

Chris Todd

Quality Assurance Manage