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Dec 10, 2020 Robert Fenton

5 FDA Audit Preparation Tips for Life Science Startups

Are you preparing for an FDA audit?

If so, there's a lot that can go wrong if your organization fails to take the time to adequately prepare.

Unfortunately, many life science companies are placed under increased scrutiny due to major nonconformities cited during FDA audits.

To make matters more complex, auditors have placed more surveillance on life science startups due to new and evolving laws and regulations. Further, auditors are now paying closer attention to internal quality management systems.

For this reason, we recommend conducting internal audits ahead of major FDA scrutiny. For example, you may want to measure your organization's quality management system against basic quality standards outlined in ISO 9001:2015.

5 FDA Audit Preparation Tips for Life Science Startups

Major governing bodies do not publish data related to pass/fail criteria. However, based on first-hand experience and FDA observation data, following these FDA audit preparation tips will significantly improve readiness.

1. Foster a Culture of Compliance

Suffice it to say that governments and agencies have created a complex regulatory environment.

As a result, life science companies sometimes struggle to understand the full scope of the compliance and risk landscape. As such, life science organizations must adopt an enterprise-wide view and culture of compliance.

However, recent studies indicate that a majority of life science organizations have already adopted a compliance-first attitude.

"About 86% of respondents indicated they receive strong or very strong support on their company's healthcare compliance effort from their company's CEO and board," reports Porzio Life Sciences. "These executives understand that violations of rules can have a costly effect on their bottom line."

2. Develop and Document Regulatory Inspection Procedure

Creating and managing regulatory submissions becomes a greater burden every year.

The sheer volume of submissions is increasing and managing amendments becomes increasingly challenging. Beyond that, auditors have placed increased scrutiny on life science organizations due to evolving regulations.

As a result, life science organizations must develop and document regulatory inspection procedures. Typically, this is done through specialized internal audits based on regulatory preparation, observation commitment, decommissioning, risk evaluation, and other FDA pre-approval inspection programs.

RELATED READING: 5 Notorious Compliance Issues in the Pharmaceutical Industry (and How to Avoid Them)

3. Appoint a Deputy Management Representative

Next, appoint a deputy management representative. While specific duties vary depending on the organization, deputy management representatives typically serve as the authoritative representative during regulatory audits.

Management representatives plan, arrange, and oversee internal audits within the organization. After a successful internal audit exercise, external audits from governmental or other reputable third-party agencies can be invited in for the final leg of the regulatory or certification exam.

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4. Practice Mock Inspections

Investing in a regulatory mock inspection exercise is a great way for your organization to experience training experiences that approximate the overall intensity of real inspections.

Another important benefit of mock inspections is to make the real inspection more authentic for those who have never participated in one. That way, employees will have a better understanding of the types of questions asked, their role in the inspection process, and how they should react during different scenarios.

RELATED READING: The Best ISO 14971 Training Programs

5. Automate Compliance

Finally, look to automate compliance through the investment in an enterprise quality management system (eQMS). Qualio is an all-in-one eQMS solution that helps life sciences companies create high-quality products, get to market quickly, and scale successfully.

Qualio serves the following key areas of focus:

  • Document Control
  • Assign and Track Training
  • Identify and Capture "Quality" Events
  • Streamline Product Development
  • Closed-Loop Quality Management

To get started, take a free product demo.

How to Maintain a Constant State of Audit-Readiness

If you're trying to maintain a continual state of audit-readiness, you need to conduct regular internal audits. It's that simple.

Your internal investigations should follow the same criteria auditors use to uncover nonconformities. Additionally, follow-up tirelessly with corrective and preventative actions and prioritize continuous quality improvement efforts.

The right tools and a commitment to building a quality-driven culture can significantly improve audit readiness.

In most cases, this all starts with investing in a quality management system.

Not sure about what to look for in an eQMS? Download our free buyer's guide, 12 Questions to Ask Before You Buy an eQMS, to learn more about how to evaluate your eQMS options.

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Published by Robert Fenton December 10, 2020