Subscription Services GxP Health-Check

Good Manufacturing Practices ensure products are produced and controlled to the appropriate quality standards while adhering to industry regulations. Resolving and preventing compliance issues for medical products requires expertise in planning, developing, and implementing Good Manufacturing Practice (GMP) quality systems.

Our quality professionals bring direct experience in pharmaceutical, biotechnology, combination, and medical device development and manufacturing to help you understand and address quality assurance needs at every stage of product development.

Our team works closely with your staff to improve processes for manufacturing, distribution, and packaging facilities.

Our quality professionals take the lead in planning, executing, and analyzing comprehensive audits to uncover potential deficiencies and make the necessary improvements, all while empowering your staff to maintain compliance well into the future.

• Our GMP auditing services include:
  
  
  • Mock Pre-Approval Inspections (PAI) and mock FDA audits
  • Mock Notified Body Inspections
  • Mock recalls
  • Vendor/supplier audits
  • MDSAP audits
  • Formal risk assessments & risk mitigation strategies
  • Quality system & corporate SOP gap analysis
• Additionally, we assist clients in:
  
  
  • Compliance master planning and strategy
  • Corrective actions and implementation plans
  • Planning and execution of remediation projects
  • Validation and qualification
  • Quality system & corporate SOP guidance and development
  • Training and development of training programs

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.

• Our comprehensive data integrity and computer systems validation services include, but are not limited to: 

   

  • Computerized and Cloud System Validation (CCSV) and qualification
  • Establishing data integrity infrastructures
  • Third party CMO audits
  • Vendor audits
  • Mock Pre-Approval Inspection (PAI) audits of data integrity
  • Formal risk assessments and risk mitigation strategies
• Additionally, we assist clients in: 

   

  • Planning and remediation assistance for data integrity gaps
  • Guidance and development of Data Governance and Data Management Programs
  • FDA-483 and warning letter responses for data integrity
  • Pre-audit preparation and support during audits
  • Training and development of training programs in data integrity and CSV