Services

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.

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Regulative

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

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Auditing

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

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Implementation

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

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Validation

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

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