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
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
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
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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