GMP AUDITING SERVICES Connect with the industry's top Good Manufacturing Practice (GMP) auditors.

When using laboratories, whether research (non-GLP), preclinical (GLP), clinical (GCLP), or commercial product QC support (GMP), it's important to ensure that data is credible and in compliance with protocols, standard operating procedures (SOPs), and regulatory requirements.

Our quality professionals plan and conduct comprehensive audits for all types of laboratories. We go beyond simply giving advice and guidance, taking an active role in solving laboratory quality issues, establishing a quality management system, preparing laboratory policies and SOPs, and planning routine monitoring and quality control test procedures.

• Audits of safety or specialty laboratories
  
• Mock FDA inspections
  
• CLIA assessments
• Qualification of GLP facilities
  
• Gap analyses
• SOP development 

When conducting clinical trials on investigational medicinal products or devices, you are required to show the planning, study conduct, performance, monitoring, auditing, analysis, and reporting all meet the ethical and scientific standards for Good Clinical Practice (GCP).

As new technologies transform the way clinical research is carried out around the world, keeping ahead of these trends is no small task. Whether you follow a traditional approach to monitoring or are transitioning to a Risk-Based Monitoring (RBM) system, our quality professionals tailor their auditing plans to accommodate your particular needs.

Our quality professionals closely examine your particular study before planning and executing study-specific GCP audits of protocols, investigator sites, trial master files, pharmacovigilance, databases, and reports.

With the help of experienced industry professionals, you can be confident knowing results are credible and accurate while maintaining quality practices throughout the research.

• Mock BIMO Inspections
• Auditing and document review for SOPs, clinical GCP protocols, and reports
• Audits of submission for ethical approval for GCP clinical trials
• Audits of clinical sites
• Audits of Trial Master Files (TMFs)
• Audits of Contract Research Organizations (CROs) and other vendors

Clinical trial audits are tailored to your particular compliance needs and stage of product development. Our Quality Assurance team has performed audits in a variety of markets both domestic and international.

Vendor/Supplier Auditing

Our certified, experienced auditors plan, schedule, and execute vendor/supplier quality management audits to identify areas of conformance and nonconformance with applicable global regulations. Following assessment, our experts provide a detailed report including all observations, deficiencies, and a risk-based corrective action plan for improvement.

With an enhancement plan in place, our quality professionals will work closely with you to provide recommendations, resolve compliance issues, track corrective actions, and communicate the status of resolutions with company management. This comprehensive approach to vendor/supplier quality management strengthens your vendor/supplier relationships while ensuring your products are of the highest quality through a quality system that is compliant and efficient.

Our vendor/supplier auditing services include:

• Vendor/supplier audit plan strategy and creation
• Vendor/supplier audit execution and project management
• Vendor/supplier audit plan maintenance and support
• MDSAP strategies and audit implementation

Pharmacovigilance Auditing

Pharmacovigilance (PV) auditing is essential when balancing the risks and benefits of a new drug, biologic, or medical device. As regulators step up pharmacovigilance and place greater scrutiny on pharmacovigilance Quality Management Systems, it's up to you to assess internal activities, vendor relationships, commercial partnerships, and others that comprise the pharmacovigilance system.

Our professionals have firsthand experience in quality management for pharmacovigilance systems. We will help you audit current pharmacovigilance systems to ensure regulatory compliance while providing your internal team with the training it needs to maintain quality processes in the future.

Data Integrity Auditing & CSV

Compliance with cGMP requires companies to record, track, manage, store, and easily access documents such as Standard Operating Procedures (SOPs), Batch Records, Test Data, and log books. Current regulations also require manufacturers to review Electronic Batch Records (EBRs) of manufactured batches and resolve all discrepancies prior to batch release. EBRs consisting of electronic records should be reliable, trustworthy, traceable, and verifiable to conform with the US FDA’s 21 Code of Federal Regulations (CFR) Part 11 and the European Union’s Annex 11.

Our data integrity, validation, and quality experts perform comprehensive computer systems and data assessments to ensure your system requirements are fully met and adequately documented.

Data governance and management practices are evaluated using risk-based validation strategies to protect the integrity of your data and strengthen your quality system in the process. Compliance gaps identified during the assessment are addressed through comprehensive remediation.

Thorough computer system validation (CSV) ensures your system stands up to scrutiny, leaving you secure in the knowledge that your data is safe, reliable, and available. Our CSV experts implement systems and obtain “fit for use” certification in the areas of computer and cloud systems validation and data integrity.

Our framework for CSV and data integrity assessment can be applied to both proprietary and commercially available software. Projects are planned and executed by leading computer system validation experts with intimate knowledge of current regulatory requirements and years of experience enhancing IT operations, control systems, and data integrity for pharmaceutical, medical device, and biotechnology companies.

Concerned your quality system doesn't reflect FDA expectations? Our active remediation model goes beyond consulting to solve a variety of compliance problems while offering ongoing project management and training services each step of the way. Once remediation is complete, we plan, implement, and audit your quality system to ensure regulatory compliance is maintained well into the future.

Our 4-Step Approach to Remediation

1. Analyze observations and choose the quality investigation model best suited to thoroughly understand the compliance issues at hand.
2. Launch an internal investigation with the assistance of key stakeholders to assess all affected processes and reveal the root causes of noncompliance.
3. Draft a comprehensive remediation plan and assure agreement by all stakeholders.
4. Implement agreed-upon corrective and preventive actions with the appropriate amount of supervision and monitoring.

 Our compliance remediation services include:

• Regulatory Observation/Warning Letter Responses & Remediation

• PAI & Inspection Readiness

• Internal Audit & Remediation Services

• Non-Conformance/Deviation Investigation Management Support

• Process Analysis & Enhancement

• Investigation, Action Plan, & Effectiveness Check 

Third-party remediation professionals offer a fresh perspective while working diligently to analyze gaps, identify root causes, resolve compliance problems, and communicate your efforts to regulators effectively.

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