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Synertec assists clients in Computer System Validation activities ranging from simple ‘as built’ documentation and system validation protocols through to complete ERP and Infrastructure qualifications for complex manufacturing environments.
Synertec has a broad range of experience in the validation of Computer Systems within regulated environments and has worked with a large number of Australian and international companies. Our consultants have experience in ERP validation and compliance activities and applying the GAMP principles to a variety of integrated, Legacy and proprietary systems.
Our areas of expertise include:
- Validation of ERP Systems
- Network & Infrastructure Qualification
- GMP and GAMP Compliance
- 21 CFR Part 11 Compliance
- Prospective & Legacy System Validation
- Application Validation
- Laboratory System Validation
- Validation of End-to-end Applications
- Quality Management System Validation
- Documentation System Validation
- Environmental Monitoring System Validation
- Building Management System Validation
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