Internal Audits: A Vital Tool for Life Science Companies

In the life sciences sector, companies are tasked with meeting strict quality, safety, and regulatory standards to protect patients and consumers. To manage these expectations effectively, life science internal audits are one of the most critical tools in assessing the performance of a company’s quality management system (QMS) and identifying areas for improvement. Whether an organization is focused on medical devices, pharmaceuticals, clinical research, or related fields, internal audits are central to compliance with regulations such as ISO 13485, U.S. Food and Drug Administration’s (FDA’s) 21 CFR Part 820, good manufacturing practices (GMP), and good clinical practices (GCP).

This blog will explore the significance of internal audits, regulatory requirements that mandate their use, how often they should be performed, and how audit management software can streamline these processes.

What Are Internal Audits?

An internal audit is a systematic examination of a company’s internal processes, systems, and controls, designed to assess whether they align with internal policies and external regulatory requirements. Internal audit procedures for manufacturing companies differ from external audits, which are typically conducted by third parties such as certification bodies or regulatory agencies. Internal audits are conducted either by an internal team or by external consultants engaged by the organization.

The primary objective of internal audits is to provide management with a clear picture of how well the QMS is functioning, identify any noncompliance or inefficiencies, and facilitate continuous improvement. By leveraging audit management software, companies can efficiently plan, execute, and document audits, ensuring all processes remain compliant and effective.

Regulatory Standards and Internal Audit Requirements

ISO 13485 Internal Audits

ISO 13485 is a globally recognized standard for quality management systems in the medical device industry. It applies to organizations that manufacture medical devices or related services, and it lays out requirements for the design, production, installation, and servicing of these devices.

Under ISO 13485 internal audit requirements, companies must evaluate whether the QMS conforms to both the standard and the organization’s requirements. These audits must be conducted at planned intervals. Clause 8.2.4 specifies that internal audits must verify that the QMS is properly implemented and effective in maintaining product quality.

Key requirements for ISO 13485 audits include:

• Developing a documented internal audit program.
• Planning audits based on risk, covering all key processes over a designated period.
• Ensuring auditors are independent and impartial to the processes being audited.
• Addressing nonconformities through corrective actions.

In addition to ISO 13485, many life science companies also adhere to ISO 9001 standards for broader quality management frameworks, which similarly emphasize the importance of robust internal audit practices.

FDA (21 CFR Part 820) – Quality System Regulation (QSR)

In the United States, the FDA enforces regulations through its Quality System Regulation (QSR), outlined in 21 CFR Part 820, which governs medical device manufacturing. On January 31, 2024 the announced that the QSR will be updated to the Quality Management System Regulation (QMSR) to be more aligned with ISO 13485. These regulations apply to all companies producing medical devices for the U.S. market.

Section 820.22 of the QSR mandates regular internal audits to assess the QMS's performance and compliance. The FDA expects companies to evaluate critical processes such as design controls, corrective actions/preventive actions (CAPAs), complaint handling, and postmarket surveillance.

Key requirements for 21 CFR Part 820 audits include:

• Planning audits at regular intervals to ensure QSR compliance.
• Documenting audit findings and taking corrective actions as necessary.
• Maintaining detailed records of audit reports and follow-up actions for regulatory inspections.

Good Manufacturing Practices (GMP)

GMP regulations ensure that manufacturers of pharmaceuticals, biologics, and medical devices consistently produce high-quality products. Internal audits under GMP should focus on critical manufacturing processes such as production controls, environmental monitoring, and personnel training.

For manufacturers, internal audit procedures for manufacturing companies emphasize:

• Reviewing critical processes involved in product safety and efficacy.
• Conducting audits of batch records, quality control tests, and raw material handling.
• Maintaining detailed documentation of audit findings and actions taken to address issues.

Good Clinical Practices (GCP)

For companies involved in clinical trials, compliance with GCP is essential. Life science internal audits in clinical settings evaluate whether the trial is being conducted according to the approved protocol, regulatory requirements, and ethical standards.

Key audit focus areas include:

• Participant safety, protocol adherence, and data integrity.
• Clinical data management, informed consent, and adverse event reporting.
• Addressing deviations through corrective and preventive actions.

Frequency of Internal Audits

The frequency of internal audit procedures for manufacturing companies, and life science companies in general, depends on regulatory frameworks, company size, operational complexity, and process risks. Regulations recommend adopting a risk-based approach to determine how often to audit key processes.

Risk-Based Approach

A risk-based approach means high-risk processes like CAPA or product design are audited more frequently. For instance:

• ISO 13485 internal audits: Audit all key processes at least once every three years, with higher-risk processes reviewed annually or biannually.
• 21 CFR Part 820 audits: Conduct regular audits to evaluate key areas like complaint handling and CAPA. · GMP audits: High-risk areas like manufacturing should be audited annually.
• GCP audits: Clinical trial audits should occur regularly throughout the study.

By utilizing audit management software, companies can streamline the scheduling and execution of audits, ensuring compliance while reducing manual effort.

Why Are Internal Audits Crucial for Life Science Companies?

Internal audits play a pivotal role in maintaining compliance, improving processes, and reducing risks. Here are some of the key benefits:

1. Maintaining Compliance With Regulations

Regular audits ensure alignment with standards like ISO 13485, FDA QSR/QMSR, GMP, and GCP. Compliance minimizes the risk of regulatory penalties or product recalls.

2. Improving Operational Efficiency

Internal audits identify inefficiencies or bottlenecks, enabling life science companies to improve workflows and enhance productivity.

3. Identifying and Mitigating Risks

Audits provide a structured approach to identifying risks early, whether in CAPA processes, clinical trials, or manufacturing workflows.

4. Supporting Continuous Improvement

Internal audits are integral to fostering continuous improvement. They help evaluate the effectiveness of the QMS and identify areas for enhancement, driving long-term operational excellence.

5. Preparing for External Audits

Frequent internal audits ensure readiness for external inspections by certification bodies or regulators. By addressing nonconformities internally, companies are better prepared for external reviews.

Key Takeaways

Internal audits are critical for assessing the effectiveness of a company’s QMS and ensuring compliance with standards like ISO 13485 internal audits, FDA QSR/QMSR, GMP, and GCP. By adopting a risk-based approach and leveraging tools like audit management software, life science companies can enhance efficiency, mitigate risks, and foster continuous improvement.

Investing in a robust internal audit program is about more than compliance—it's about building a culture of quality and excellence that benefits customers, employees, and the patients relying on safe and effective products.

Sources

• International Council for Harmonisation. (2025). ICH E6 (R3): Good Clinical Practice (GCP) guidelines. ICH GCP Guidelines
• International Organization for Standardization. (2016). ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes. ISO Official Website
• U.S. Food and Drug Administration. (2024). 21 CFR Part 820 - Quality system regulation. FDA Regulations
• U.S. Food and Drug Administration. (2025). Current Good Manufacturing Practice (CGMP) regulations. FDA Pharmaceutical Quality Resources