Focused on international development of automated, electronic compliance management solutions for GMP Quality Assurance manage­ment that will greatly reduces regulatory complexities and risk for non-compliancy, and finally costs.

QAtor has an international proven track record in assisting Life Science companies with comprehensive do­cu­men­tation and com­pliance management solutions for various governmental agencies.

Regulatory

• FDA cGMP Policies
• ISPE GAMP 4 Guidance
• EudraLex Legislation and Guidelines

Auditing

• GMP – GLP – GCP – Process Audits
• 21 CFR Part 11 Audits
• Validation Documentation Audits
• SOP and VMP Audits
• Vendor & Supplier Audits

Implementation

• 21 CFR Part 11 Electronic Records
• ISO 17025 Implementation
• GMP System Development Projects
• Computer Systems Baseline Reporting

Validation

• Equipment (Manufacturing, R&D, Lab., Utilities and Facility)
• Computer Systems Validation
• Process Validation
• Clean Room Validation