• ✅ Internal Audits: Our experts conduct thorough internal audits to assess compliance with Good Manufacturing Practices (GMP) across all areas of your organization. We identify gaps, non-compliances, and opportunities for improvement to enhance operational effectiveness.
• ✅ Supplier Audits: We assess the GMP compliance of your suppliers and contractors, helping to secure your supply chain and ensure that your partners meet your organization’s quality and safety standards.
• ✅ Pre-Certification Audits: QMS4 performs detailed pre-certification audits to prepare your organization for official GMP certification or regulatory inspections. This includes identifying and addressing potential compliance issues to streamline the certification process.

• ✅ Mock Regulatory Inspections: Our team provides simulated regulatory inspections to prepare your facility for official inspections by agencies like the FDA, EMA, and local authorities. We offer practical feedback and guidance to help you meet industry requirements.
• ✅ Compliance Audits: QMS4 conducts compliance audits to verify adherence to regulatory requirements and GMP standards, assisting your organization in meeting both local and international regulatory obligations.
• ✅ Inspection Remediation Audits: If your organization has undergone a regulatory inspection and received findings, we can conduct audits to support remediation efforts. We identify root causes, develop corrective actions, and help you implement solutions that ensure future compliance.

• ✅ Process and System Audits: We evaluate your manufacturing processes, systems, and facilities to ensure they align with GMP standards and support product safety and quality. This includes assessing equipment, documentation, and operational controls.
• ✅ Risk-Based Audits: QMS4’s risk-based audit approach focuses on identifying and mitigating risks in critical areas of your operations. We assess potential risks to product quality, safety, and compliance, helping you prioritize improvements where they matter most.
• ✅ Continuous Improvement Audits: Our continuous improvement audits help you maintain a high standard of GMP compliance by identifying opportunities for ongoing enhancements. We provide insights into best practices and recommendations to optimize your operations and drive quality improvement.

• ✅ CAPA Development and Implementation: After each audit, we assist with Corrective and Preventive Actions (CAPA) to address findings and improve your compliance framework. We work with your team to develop actionable CAPAs and monitor their implementation to ensure lasting results.
• ✅ Deviation and Change Management: QMS4 provides support for managing deviations and changes to your manufacturing processes. We help document, assess, and control changes, ensuring that modifications align with GMP requirements and maintain compliance.
• ✅ Ongoing Monitoring and Follow-Up Audits: We offer follow-up audits and ongoing monitoring to help you maintain GMP compliance over time. This includes re-assessing areas previously identified for improvement and providing guidance on sustaining regulatory adherence.

• ✅ Food Safety Audits: For the food industry, we perform specialized audits to ensure compliance with GMP and food safety standards. This includes compliance with FDA regulations and industry-specific standards like ISO 22000 and HACCP.
• ✅ Pharmaceutical Compliance Audits: Our pharmaceutical audits focus on meeting stringent GMP requirements for the production of safe, effective medicines. We help ensure that manufacturing processes prevent contamination, cross-contamination, and adhere to regulatory expectations.

✅ API Compliance Audits: QMS4’s API audits are designed to ensure that your active pharmaceutical ingredient manufacturing processes meet GMP standards. We assess quality control, documentation, and production practices to support consistency and regulatory compliance.