Famed for their 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) conditions 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, the CQAU team is 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. The CQAU team implemented Q-Pulse, the compliance management solution developed by Gael, to manage their compliance needs, which includes equipment, calibration and maintenance records. Q-Pulse also helped the laboratories to respond to any non-conformances from their audits. To further enhance their system, the CQAU team took advantage of Q-Pulse Docs and Q-Pulse Audit apps - extending the solution to the tablet and helping to reduce their paper load to ease the completion of clinical trials’ specimen testing.
Chris Todd, Quality Assurance Manager of the CQAU, said: "As our Quality Assurance team is in charge of performing multiple audits to make sure our laboratories meet GCLP requirements, we were faced with a great deal of paperwork and managing this was cumbersome.
"For example, we perform numerous audits on different types of immunogenicity assays for human clinical trials. When you take into consideration that we have around five audits a month, complete with paper based checklists with about 200 questions and around 300 SOPs that we need to manage, you can get the idea of the effort that goes into that."
Both Q-Pulse Docs and Q-Pulse Audit for the tablet 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. With the Audit app they have removed the need for paper-based auditing in the lab. The administrative overhead of rekeying findings back into their central Q-Pulse system has also been removed by using the app.
Chris added: “In terms of paper, a lot of the labs we have are Biosafety Level 3 Labs (BSL) so once paper goes in, such as checklists and SOPs, it is very difficult for it to come out, following appropriate quarantine procedures. 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. The previous paper system became quite cumbersome as we would need to take with us pages and pages of SOPs, 20 page audit checklists for each audit and manage all those papers while we were in the lab. Trying to keep all of that clean was extremely difficult.
“Having both Q-Pulse Docs and Q-Pulse Audit apps allows us to go from SOP to SOP really quickly and allows us to type directly into the audit checklist without paper and pen. One of our concerns prior to getting the apps was being able to type with gloves on – sometimes with two pairs. But even with gloves, we can type easily.
“One thing we really love is that you can raise non-conformances and observations directly from the checklist module on the tablet – and questions turn green when you answer them so we know exactly where we are during audits. The amount of audits and audit checklists that we have to complete vary but are all extremely lengthy. But the apps mean that now we do not have to carry so much paper around and we are really pleased with such change.”