Famed for its extensive HIV vaccine research, a number of laboratories at Duke University Medical Center (DUMC) in Durham, North Carolina, conduct immunogenicity testing of numerous HIV-vaccine human clinical trial specimens in compliance with Good Clinical Laboratory Practice (GCLP). These operations are conducted under the oversight of a Central Quality Assurance Unit (CQAU).
Until recently the CQAU staff had to manage around 300 standard operating procedures (SOPs), all of which were paper based. Added to this, they were also in charge of performing multiple audits to ensure the laboratories were continuously meeting GCLP requirements. The amount of paperwork that laboratory and CQAU staff had to manage during trials and audits was extremely labour intensive.
Both Q-Pulse Docs and Q-Pulse Audit apps helped the CQAU remove the need for paper from their previous processes. For example, staff can now access all of their SOPs via the Docs app, while the Audit app helped them remove the need for paper-based auditing in the lab. The administrative overhead of re-keying findings back into their central Q-Pulse system has also been removed by using the app.
- Both Q-Pulse Docs and Q-Pulse Audit for iPad helped the CQAU remove the need for paper from their previous processes
- Staff can now access all of their SOPs via Q-Pulse Docs app on the move
- Q-Pulse Audit for iPad removed the need for paper-based auditing in the lab, while administrative overheads of re-keying findings back into their central Q-Pulse system has been removed
- Having everything on the apps allows staff to keep and use the iPad in Biosafety Level 3 Labs (BSL) - no need for mountains of paper and several page audit checklists for each audit
- Raise non-conformances and observations directly from the checklist module on Q-Pulse Audit for iPad
The really great thing about the apps is that having everything on the tablet allows us to keep it on a clean surface and, if there is any doubt, we can simply wipe it down with ethanol.Chris Todd, Quality Assurance Manager, Duke University Medical Center