Types of Assessments / Audits

Quality Assurance Programs

Review of Change Control / Configuration Management Programs
Document Control Systems
Batch Record Review

Regulatory Compliance Assessments may include:

Evaluation of Quality Systems
Internal cGXP Audits
cGMP Compliance Evaluation
Review of Validation Studies, and Documentation
Review of Investigation Reports and Resolution of Compliance and Quality Problems
Compliance Review of Facilities and Equipment
Review of Employee Training Programs/ Vendor Qualifications
Software Assessment Against IEEE Standards
Computer Systems Validation
System Security, Vendor Audits
SOP, Programs and Corporate Policies
Analytical Laboratories Audit