Be Confident and Ready for Your Next Regulatory Inspection

Get your employees inspection ready with a mock audit.

Back in March 2020, the U.S. Food and Drug Administration (FDA) announced that it would rely on virtual audits during the pandemic. For companies in the early stages of digital transformation—or that hadn’t started their transition at all—making documentation and vendor records accessible to auditors resulted in a lot of overworked and frustrated auditees.

Nearly three years later, life sciences companies have come a long way in rethinking their business workflows and cloud-based technology solutions. Still, audits and regulatory inspections are capable of inducing anxiety in even your most seasoned employees. When new hires or those with little to no audit experience are brought in to help, they are often overwhelmed and nervous. To ensure that everyone is calm, confident, and ready with the documents commonly requested by auditors, include a mock audit in your preparation.

Conducting a mock audit will help you prepare your people, processes, and technology and lessen the anxiety surrounding a real audit.

Experience a stress-free and productive audit

Mock audits are the key to managing an inspection. Auditees will learn what is expected of them, how to establish a workflow process, and how to use a content management system (CMS) so that all employees and the auditor have a stress-free and productive experience. For example, using Box as your CMS, you are able to share access to documents and assign tasks and deadlines. Auditors can leave feedback via comments, or you have the option to set permissions to read-only. Watch the Virtual Audits and Inspections on-demand webinar for more information.

Doing a virtual mock audit helps you identify issues with equipment and bandwidth so you can resolve them before they disrupt the inspection. It’s wise to include your IT team and safety officer if you plan to use augmented reality, virtual reality, or any type of interactive experience. Read the Best Practices for Virtual Audits and Inspections white paper for more examples and recommendations.

How USDM can help

USDM Life Sciences has been conducting audits and assessments for the biotech, medical device, and pharmaceutical industries for more than 20 years. Our inspection readiness services will help you ensure that everyone involved is familiar with audit protocols so that your company can minimize risks, fines, and fees.

Download our Inspection Readiness datasheet to learn more.

We specialize in software vendor and supplier qualification and tailor GxP audits to your needs. Our regulatory audits focus on investigating specific systems and processes to ensure they meet regulatory requirements and industry standards. We identify observations and gaps in systems and processes, and we verify that processes are documented and being followed. Our years of unmatched industry expertise enables us to find and address your potential risks.

Whether you’re preparing for an on-site or remote audit, USDM’s inspection readiness service will help you:

• Anticipate auditor requests based on their agenda
• Make the appropriate documentation available to the auditors
• Include your IT team and on-site safety officers
• Overcome technological issues that may interrupt an audit
• Develop your own checklist for ongoing audit preparedness

Contact your account manager to get started or contact USDM here.