What’s the Difference Between an Audit and an Inspection?

When the U.S. Food and Drug Administration (FDA) or any other regulatory agency shows up to your workplace, it’s a big deal. The most common term for a workplace review of this sort is audit, but there are important differences between audits, inspections, and assessments. Knowing these differences is crucial to being prepared for them and for safeguarding your organization’s reputation and market access.

This blog will examine audits, inspections, and remote regulatory assessments so you can ensure you and your team are always ready when regulators come knocking.

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Audits Vs Inspections

While they share many similarities there are differences between audits and inspections. Audits are typically broader reviews of an organization’s processes, procedures, documentation, training programs, and performance metrics. Generally, but not always, these are not legally binding, but can serve to prompt future inspections. Audits can be conducted by internal or third-party investigators. Findings are formally documented, and the information may be shared with other regulatory agencies.

Audits are typically part of planned audit programs, especially when conducted internally. They may be conducted in-person or via a virtual review of documentation. Some types of audits include:

• International Organization for Standardization (ISO) or GxP Audits
• Internal Audits
• Customer/Client Audits (for contract manufacturers for example)

Inspections are typically more focused on specific processes, products, or facilities. These can carry legal consequences such as fines or even prosecution for egregious offenses. They are conducted by regulatory or enforcement agencies. Inspections may be planned or triggered by circumstances such as complaints, poor audit performance, or negative events (such as an accident or recall). Inspections are defined by the FDA as “physically entering establishments.”

Types of inspections include:

• General or Surveillance Inspections
• For Cause Inspections (initiated when there’s reason to believe a facility has quality problems)
• Application-Based Inspections (part of bringing new products to market)

What Are Remote Regulatory Assessments?

Less frequent, but with expanding regularity, are remote regulatory assessments (RRAs). These are virtual assessments from the FDA that began during the COVID-19 pandemic and have been approved for continued and expanded use. RRAs can be voluntary or mandatory and are typically conducted when the FDA cannot conduct an inspection due to travel limitations or if it determines a remote assessment is sufficient to conduct oversight and support regulatory decisions.

These do not result in legal action; however, they may influence regulators’ decisions on inspections. Taking RRAs seriously is important to limit regulatory interruption and foster a good working relationship with authorities.

Preparing for an Audit or Inspection

Each audit or inspection will look slightly different than the last, however, at a high level, they follow similar procedures that allow for organizations to adequately prepare. For an ISO-related audit, the scope is different than a general inspection, and the processes change per standard. While it is always important to be diligent, it’s likely an organization will become accustomed to these audits.

A general inspection is a high-risk to an organization that isn’t prepared. During those, the investigator will systematically review various aspects of your facility:

• Records: They’ll review production records, quality control data, SOPs, and other relevant documentation
• Processes: They’ll examine manufacturing processes, maintenance practices, and compliance
• Samples: They may collect samples of raw materials or ingredients, finished products, or environmental swabs

Their goal is to assess adherence with regulations and identify any nonconformities.

Ensure Data Integrity and Accessibility

Whether it’s an audit, inspection, or a remote regulatory assessment, it’s crucial your documents are 21 CFR Part 11/Annex 11 compliant regarding data integrity standards and that you can quickly access requested documentation. Strong data and document management processes are essential to audit readiness.

Kneat’s digital validation solution builds data integrity into every step of the validation lifecycle. Complete with automatic time stamps and audit trails, password-protected electronic signatures, and complete elimination of paper, Kneat Gx provides comprehensive compliance to all organizations.

Centrally stored, Kneat’s data and documents can be automatically tracked using the Real-Time Requirements Traceability Matrix (RTM). This makes it easy for users to trace, find, and access the documents they need, as soon as they need them. During an audit or inspection, this is crucial to satisfying investigator’s demands.

When it comes to handing these documents off, Kneat’s ‘Collections’ feature serves as a virtual audit War Room. Enabling investigator’s easy access to any pre-approved documentation. These digital versions are perfect for remote assessments and remove any requirement for scanning

See how Kneat Gx gets you audit ready in our monthly demo webinar. Sign up to secure your spot now!

About the Author

Tristan Worden – Senior Content Marketing Strategist, Kneat

Tristan has over a decade of experience communicating complex ideas to both general and specific audiences with almost five years in the compliance and validation sector. He is passionate about ensuring validation professionals have the information they need to do their jobs effectively.