[ BIO­-IT SERVICES & RESEARCH COMPANY ]

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

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

• 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

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

• 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

• 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)

• 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