Get your employees inspection ready with a mock audit.
The short version: Regulatory inspections rattle even seasoned teams, and they can overwhelm newer employees who have never sat across from an auditor. A mock audit rehearses the real thing—aligning your people, processes, and technology before inspection day—so requested documents are at hand, technology works, and everyone stays calm and confident.
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.
Because inspectors routinely scrutinize how electronic records are created, controlled, and trusted, your mock audit is also the right moment to pressure-test your 21 CFR Part 11 posture and the data integrity of the systems an auditor is most likely to request. Confirm that audit trails are intact, access controls are appropriate, and records can be retrieved on demand.
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.
A simple mock audit framework
- People — Rehearse roles. Make sure auditees, IT, and your safety officer know what is expected of them and how to respond to an auditor’s requests.
- Process — Verify that procedures are documented and actually being followed, and that observations and gaps are identified before a real inspector finds them.
- Technology — Test your CMS, equipment, bandwidth, and record retrieval so nothing breaks mid-inspection.
- Suppliers — Confirm that vendor and supplier qualification records are current and accessible, since third-party systems are squarely in scope.
The goal of a mock audit isn’t to pass a test—it’s to make inspection day feel routine.
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. Strengthening your third-party risk management program ahead of an inspection helps ensure that the vendors and systems you rely on can stand up to auditor scrutiny. 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. A risk-based Computer Software Assurance (CSA) mindset helps you focus that evidence where it matters most. 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
FAQ: Preparing for a Regulatory Inspection
What is a mock audit?
A mock audit is a rehearsal of a real regulatory inspection. It helps auditees learn what is expected of them, establish a workflow process, and practice using a content management system so that employees and auditors have a stress-free, productive experience on inspection day.
Why should we conduct a mock audit before a real inspection?
A mock audit prepares your people, processes, and technology and lessens the anxiety surrounding a real audit. It surfaces issues—missing documentation, equipment or bandwidth problems, undocumented processes—while you still have time to resolve them.
What’s different about a virtual or remote audit?
Virtual audits add technology risk. A virtual mock audit helps you identify issues with equipment and bandwidth so you can resolve them before they disrupt the inspection, and it’s wise to include your IT team and safety officer—especially if you plan to use augmented reality, virtual reality, or other interactive experiences.
How can USDM help us get inspection ready?
USDM has been conducting audits and assessments for the biotech, medical device, and pharmaceutical industries for more than 20 years. Our inspection readiness services help ensure everyone involved is familiar with audit protocols so your company can minimize risks, fines, and fees, and we tailor GxP audits and supplier qualification to your needs.
Ready to walk into your next inspection with confidence? Contact your account manager to get started, or contact USDM here to discuss inspection readiness for your team.