Auditing Services

What we do ­

  • Clinical Data Management Auditing
  • Pharmaco vigilance Auditing­
  • FDA Auditing-Microbiology
  • HACCP Auditing
  • GCP
  • GLP
  • GMP
  • Data Integration
  • 21 CFR Part 11
  • Software Testing Auditing
  • Data Migration

Vendor Auditing

  • Audit plan strategy and creation
  • Audit execution and project management
  • Audit plan maintenance and support
  • Audit implementation

GCP Auditing

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

GLP Auditing

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

GMP Auditing

  • Compliance master planning and strategy
  • Corrective actions and implementation plans
  • MDSAP audits
  • Formal risk assessments & risk mitigation strategies
  • Mock Notified Body Inspections
  • Vendor/supplier audits
  • Quality system & corporate SOP gap analysis
  • Mock Pre-Approval Inspections (PAI) and mock FDA audits
  • Validation and qualification
  • Quality system & corporate SOP guidance and development
  • Training and development of training programs
  • Planning and execution of remediation projects

Services We provide

  • Reviewing and improving management controls

  • Preparing policies, quality standards, and SOPs

  • Reviewing batch records

  • lanning, conducting, and/or managing remediation projects

  • Conducting oversight programs for senior leadership

  • Reviewing and improving training resources

  • Executing site-wide organizational improvement plans

  • Performing GxP audits

  • Identifying and assuring the “c” in cGMP: melding industry standards with ever-changing regulations
  • Enhancing management controls

  • Performing MDSAP audits
  • Planning and conducting mock FDA inspections

  • Performing global supplier and vendor audits
  • Identifying and closing data integrity gaps in a GxP environment
  • Performing root cause investigations, progressing Corrective and Preventive Actions (CAPA)

Data Integration Services

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