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Computer System Validation
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Synertec's areas of expertise include:
- 21 CFR Part 11 Compliance
- Application Validation
- Building Management System Validation
- Documentation System Validation
- Environmental Monitoring System Validation
- GMP and GAMP Compliance
- Laboratory System Validation
- Network & Infrastructure Qualification
- Prospective & Legacy System Validation
- Quality Management System Validation
- Validation of End-to-end Applications
- Validation of ERP Systems
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The project was to implement and validate the complete Navision ERP system. The new system was intended to help streamline operations from a combination of paper and computer based systems to a uniform ERP system across all departments. The transition to the Navision ERP system would improve plant operations from both a business and an FDA/TGA regulatory perspective.
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