Focused on international development of automated, electronic compliance management solutions for GMP Quality Assurance management that will greatly reduce 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.
QAtor provides services to your pharmaceutical company to become compliant with the following regulations:
- FDA cGMP Policies
- ISPE GAMP 4 & 5 Guidance
- EudraLex Legislation and Guidelines
QAtor provides auditing services in the following areas:
- GMP – GLP – GCP Process Audits
- 21 CFR Part 11 Audits
- Validation Documentation Audits
- SOP and VMP Audits
- Vendor & Supplier Audits
Our services can be used in the implementation of the following but not limited areas:
- 21 CFR Part 11 Electronic Records
- ISO 17025 Implementation
- GMP System Development Projects
- Computer Systems Baseline Reporting
QAtor provides services in validation of the following areas:
- Equipment (Manufacturing, R&D Lab.,
Utilities and Facility)
- Computer Systems Validation
- Process Validation
- Clean Room Validation
Over 50 years of combined life science and Quality Assurance experience within Qator A/S.
Applying the newest tools and methods to enhance your company’s success, by improving compliance and traceability.
Possibility of intergration with other systems.