Are Your Quality Systems Inspection Ready?
An excellent and sustainable quality management system is the heartbeat of pharmaceutical safety and long-term compliance. This week in the Guardrail, we examine the shift from reactive audit preparation to a proactive culture of regulatory excellence.
An excellent and sustainable quality management system is the heartbeat of pharmaceutical safety and long-term compliance. This week in the Guardrail, we examine the shift from reactive audit preparation to a proactive culture of regulatory excellence.
By Michael Bronfman, for Metis Consulting Services
January 26, 2026
Quality systems are essential for every pharmaceutical company. Quality Assurance and Quality Control ensure that drugs are developed, manufactured, and distributed safely and in compliance with regulations. Inspection readiness means more than just passing an FDA or EMA inspection; it involves building a culture of quality that supports compliance, efficiency, and public trust.
Regulators expect companies to have strong quality systems, and inspections test how well these systems work in practice. Companies that start preparing only after receiving an inspection notice run into problems that could have been avoided with earlier preparation.
Understanding Quality Systems
A quality system is a group of policies, procedures, and practices that help products consistently meet requirements. It includes document control, change management, handling deviations, corrective and preventive actions, audits, and training.
The FDA provides guidance on quality systems through regulations such as 21 CFR Parts 210 and 211 for pharmaceuticals and Part 820 for medical devices.
Information is available at https://www.fda.gov/industry.
The EMA also guides good manufacturing practice and quality system expectations at Good Manufacturing Practice | European Medicines Agency (EMA)
Understanding the regulatory framework is the first step toward being ready for inspections.
Inspection Readiness Is Continuous
Inspection readiness is not a one-time task; it is part of everyday work. Internal and external (consultants, contractors, and vendors) staff need training on procedures and are expected to understand how their work supports overall quality.
Key components of inspection readiness include:
Up-to-date documentation: Standard operating procedures, batch records, validation protocols, and training records should always be current and complete.
Traceability: Actions and decisions need documentation so any process can be followed from start to finish.
Accountability: Roles and responsibilities should be clear, and staff should be able to show they understand their tasks.
Continuous monitoring: Metrics and trends are expected to be reviewed regularly to identify potential issues before they worsen.
Conducting Self Assessments
Self-assessments, or internal audits, are one way to prepare for inspections. They help to identify gaps, verify compliance, and offer staff a chance to practice answering regulator questions.
To make self-assessments and process reviews effective, review each quality system process to ensure it complies with procedures and regulations. Audits of records include randomly selected records to check for accuracy, completeness, and timeliness, mock inspections, where a regulatory inspection is simulated, help train staff, and identify weak areas. Any issues identified during self-assessments are to be remedied through corrective and preventive actions. Taking this proactive approach reduces risk during an actual inspection.
Document Control and Data Integrity
Document control is central to every quality system. SOPs, training records, batch records, validation documents, and audit reports are always to be current, well-organized, and easy to access.
Data integrity is crucial. Regulators expect records to be accurate, complete, and protected from unauthorized changes.
FDA guidance on data integrity and compliance is available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations
Maintaining strong document control and data integrity builds trust in the quality system and helps with inspection readiness.
Training and Competency
Staff training goes beyond completing courses. Employees should understand their roles, know the procedures, and demonstrate competency.
Training programs should include:
Initial onboarding on quality system expectations
Role-specific technical training
Refresher training for updates to procedures or regulations
Records demonstrating completion and comprehension
Skilled and confident staff play a significant role in successful inspections.
Corrective and Preventive Actions
No system is perfect, so deviations and nonconformities will happen. How a company responds shows the strength of its quality system. Active CAPA programs include:
Root cause analysis: Find the real reason for the issue, not just the symptom. Effective action: Address the specific issue promptly and completely
Preventive action: Make changes to stop the problem from happening again. Confirm that the CAPA has resolved the issue and improved the process.
Inspectors look closely at CAPA records. Well-documented CAPAs demonstrate that the company is proactive and compliant with regulations.
Audit Programs
Internal and external audits are essential for ongoing improvement. Regular internal audits help find gaps and improve processes. Vendor audits ensure suppliers meet quality standards and regulatory requirements.
Audits should include documented findings, follow-up actions, and checks to confirm that changes were effective. A robust audit program shows regulators that quality is actively managed.
Managing Regulatory Inspections
When an FDA or EMA inspection takes place, being prepared makes a big difference. Key steps include:
Leadership involvement: Make sure managers are visible and know what is going on.
Document accessibility: Keep records organized so they can be found quickly.
Staff readiness: Train staff to answer questions with facts and confidence.
Issue resolution: Set up a process to document follow-up and respond to any observations. Inspectors look at both compliance and the company’s culture of quality and ongoing improvement.
Leveraging Technology
Quality Systems are encouraged to use technology to work more efficiently and track progress. Electronic quality management systems (eQMS) help with document control, CAPA tracking, training management, and audit programs. Using technology properly improves traceability, reduces errors, and makes inspection preparation easier. It also helps monitor trends and risks.
Continuous Improvement
A quality system that is always ready for inspection is continuously evolving and improving. Continuous improvement helps processes develop, closes gaps, and uses lessons from audits, assessments, and daily work.
Reviewing metrics and trends, and comparing them to industry standards, helps maintain high performance. Companies that focus on continuous improvement are better prepared for inspections and achieve better quality results.
Looking Ahead
Inspection readiness is not just a checklist. It is an ongoing commitment to quality, compliance, and patient safety. Integrating training, documentation, monitoring, and continuous improvement into daily work, companies can reduce risk and demonstrate regulatory excellence, transparency, and accountability.
Organizations that embrace these expectations and maintain strong quality systems will be able to respond confidently to inspections, protect patients, and sustain long-term success.
Ready to transform your compliance strategy? Contact Metis Consulting Servicestoday to schedule a consultation with our team of experts.