Regulatory Compliance  

It is difficult to keep up with changing Current Good Manufacturing Practices (cGMP) and regulatory requirements. Our associates are experienced professionals who keep pace with the ever changing regulations as well as the state of the validation industry. We can help you to plan, develop, and implement regulatory and compliance programs including:

  • Facility / System Design Review
  • 21 CFR Part 11 - Electronic Records and Signatures
  • Laboratory Controls
  • Documentation Management and Control
  • Regulatory Submissions
  • GMP Drivers in Technology Transfer
  • Validation Management
  • Internal and Vendor Audits
  • Training Programs
  • Environmental Monitoring Program Development
  • Microbiological Assessment of Manufacturing Processes
  • Development of Quality Manuals and SOPs
  • Batch Record Review

Validation 21CFR Part 11 Services Regulatory Compliance Startup & Commissioning
SAP Validation ERP Validation
Training Approach FDA Compliance Training SAP End User Training
Prior to Production Startup Equipment Validation Facilities Validation Computer System Validation

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