Maintaining audit-readiness is the best way to ensure that your site is prepared for audits and inspections, both planned and unplanned. This proactive approach prevents headaches and last-minute scrambling by staff in the event of an actual audit. The following tips will help you ensure that your team is audit-ready.
Create and establish an audit-readiness plan. This plan will include several processes, including but not limited to, documentation management, vendor and technology qualification, employee training programs, and an employee feedback program. Another key component is having a technology access plan; a process for supplying online access to your systems (e.g., RealTime Access Portal). Maintaining an annual internal audit program with a CAPA plan (Corrective Action/Preventive Action) will help detect gaps and opportunities for improvement before an external audit occurs.
Perform mock audits to ensure compliance and identify areas for improvement. As a continuous process, the appropriate staff should ensure all procedures, study-specific or clinic, have been properly followed and any deviations resolved. This will include all clinic staff’s current curriculum vitae, licenses, and training records are filed in accordance with the clinic’s SOPs. Study-specific records can be reviewed continuously throughout a trial to ensure adequate maintenance of records, whether paper based or electronic. While this is a short list of activities that can help your team prepare, being prepared at all times will ensure success during planned and unplanned audits.
For Part 11 compliant technology (e.g., RealTime-eDOCS/eSOURCE), ensure that all current validation documents and compliance letters are available. Most auditors will request software compliance and regulatory documentation for all Part 11 compliant applications, since these systems track, collect, and analyze study data.
You and your team should relax and trust that your thorough audit-readiness plan sets you up for success. All of your hard work and preparations will pay off! If an audit does occur, it’s good to have an SOP for hosting an audit. This SOP will assign a team to quickly coordinate and respond to all requests made by the auditor and ensure that processes are being followed. If the auditor has findings (they typically do), remind the team that everyone is human, and mistakes are expected. Be honest and ask for recommendations on how to fix an identified issue. The auditor will want to make sure that you can adjust and prevent the issue from occurring again. Take the advice as positive criticism!
Being prepared for audits and inspections requires a thorough audit-readiness plan, ongoing preparation and the ability to execute processes when hosting an audit. Showing Auditors your team is a well-oiled machine, will set the tone for all future engagements. Follow these simple steps to be the ‘Sage on the Stage’ and let RealTime be your ‘Guide on the Side’.
RealTime-eSOURCE and RealTime-eDOCS offer exemplary built-in parameters that enforce these compliance standards. Are you ready to make the switch to audit-ready clinical trial software? Get started by scheduling a free demo with a RealTime expert! Call us at 210-852-4310 or fill out the form below!