A Viewpoint by Yaassin J., Head of Life Science: Quality & Regulatory Center of Excellence

Life sciences companies face several challenges, including pricing pressures from healthcare reforms. These market forces present both threats and opportunities for businesses operating in the life sciences industry.

Understanding the complexities of audits is essential for internal quality assurance, certification, and regulatory compliance.  Auditing in the life sciences sector involves investigating, verifying, and reviewing records and activities related to product production, distribution, marketing, and sales. The aim is to ensure compliance with relevant laws, regulations, and standards. Auditors assess various factors, including supply chains, manufacturing processes, quality control systems, and company documentation.

Given these challenges, this guide explores the world of life science audits, offering insights and strategies for companies to meet regulatory demands and use audits as tools for continuous improvement and competitive advantage.

Specific purposes

Life science audits are crucial for ensuring adherence to regulatory standards, evaluating the effectiveness of Quality Management Systems (QMS), and identifying areas for improvement. These audits include various types, such as internal assessments, external certification audits, technical product/supplier evaluations, and external inspections by regulatory bodies like the FDA. Each type serves a specific purpose, from aligning internal processes with organizational objectives to ensuring product safety and performance standards are met.

Upholding regulatory compliance

Understanding the different types of audits is essential for effective preparation and response. Here’s an overview of the primary audit types:

• Internal Audits: These audits focus on examining internal processes, systems, and controls to identify improvements and prepare for external inspection. They are foundational for continuous quality improvement within the organization.
• Technical Product/Supplier Audits: Designed to ensure product compliance and supplier quality, these audits verify that products meet essential safety and performance benchmarks, maintaining product integrity and reliability.
• External Audits for Certification: Key for obtaining and maintaining certifications like ISO 13485 for medical devices, these audits demonstrate the alignment of the QMS with relevant standards.
• External Inspections on Product Safety: Conducted by regulatory bodies like the FDA, these inspections ensure products meet stringent safety and quality standards to protect consumers. For example, in the US regulatory conformity is achieved through regulations such as the Quality System Regulation (QSR).
• Mock FDA Inspections, MDSAP Audits, and more: A deep understanding of the regulatory environment is key for preparing for audits like mock FDA inspections and MDSAP audits, ensuring audit readiness and compliance.
• ISO 13485, 21 CFR 820, MDR, and IVDR Quality Systems: Companies must adhere to these standards and regulations to guarantee consistent product design, manufacturing, and delivery.
• QMS Gap Assessments: These assessments identify variances between the QMS and industry standards, providing insights for continuous improvement and regulatory adherence.

From start to finish

The audit process encompasses several key stages, each crucial to ensure its success:

• Effective Planning lays the foundation for a successful audit. This stage involves gaining a comprehensive understanding of the audit’s scope, objectives, and criteria.
• Preparation is essential for mobilizing audit teams and ensuring that all necessary arrangements are in place. This includes raising employee awareness about the audit and organizing logistics.
• The execution phase involves carrying out the audit according to the planned approach. This includes conducting interviews with key personnel, collecting evidence to support findings, and evaluating processes and controls against established criteria.
• The follow-up phase is critical for addressing any deficiencies identified during the audit. This involves developing comprehensive change management strategies based on the feedback and recommendations from the audit. It may require implementing new processes, procedures, training programs, or even organizational restructuring to improve compliance, efficiency, and overall performance.

Team coordination

Preparing for a successful audit goes involves more than just logistical arrangements; it requires thorough organizational and documentation preparation. This involves the coordination of three key teams:

• The Audit Team: This team is responsible for coordinating the audit visit, collaborating with other departments or teams, and providing support throughout the audit process. Their role is key in ensuring smooth communication and coordination between various stakeholders.
• Subject Matter Experts (SMEs): SMEs bring invaluable expertise to the audit process. Their in-depth knowledge of specific areas or processes is crucial for addressing the auditor’s queries and demonstrating the organization’s commitment to quality and compliance.
• The Support Team: This team assists both the audit team and SMEs by compiling evidence, preparing documents, and facilitating the overall audit process.

It’s important to ensure that all employees understand their roles and responsibilities related to the audit, as well as the audit’s scope. This fosters a culture of readiness and compliance throughout the organization, ensuring that everyone is aligned and prepared for the audit.

Moreover, efficient audit logistics are also key to successful inspections. This includes setting up dedicated rooms for auditors and support teams, ensuring the availability of necessary equipment and resources, and adopting practices for quick evidence collection and review.  Timely recording of actions and discussions throughout the audit is crucial for enabling prompt follow-up and continuous improvement initiatives based on the findings.

Embracing a proactive approach

Maintaining a constant state of audit readiness is indispensable in the life sciences sector.  Adopting a proactive approach, where documentation and processes are designed to meet standards from their inception, is fundamental for sustained success. While Corrective and Preventive Actions (CAPAs) offer value, their application should be strategic rather than seen as a universal solution.

Tailored training programs that address the specific needs of each organization are vital. By covering key standards, procedures, and regulations, these training sessions ensure that all team members are well-prepared for compliance and continuous improvement efforts.

Audits in the life sciences industry go beyond mere regulatory compliance; they serve as opportunities for companies to affirm quality, demonstrate compliance, and pave the way for ongoing improvement. By understanding the audit process, preparing meticulously, and embracing a mindset of continuous learning and adaptation, audits can be transformed from obstacles into strategic assets.

For further details on our services and how we can respond to your specific needs, contact us or explore our Life Sciences: Quality & Regulatory Center of Excellence.