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We develop and roll out systems that ensure the tested baseline is controlled and maintained throughout the operating lifecycle of a plant.
Synertec personnel offer a wealth of experience in cGMP compliance as we have learnt our trade as production/QA personnel or as auditors working within a production environment. This enables us to develop and implement practical solutions that are embraced by production personnel.
We offer our clients:
- A practical, risk based approach to compliance
- An approach that is leveraged off ‘hands on’ production experience
Areas that Synertec personnel have wide expertise and consulting experience include:
- AQIS 3rd Party Assessments
- Vendor Assurance
- Audit readiness inspections
- Change Control
- Maintenance/Asset management
- Calibration
- Training and GMP Training
- Process Analytical Technologies
- Environmental Monitoring
- Building Management systems
- SOP Development
- Quality Management and Documentation Systems
- 21CFR part 11
- Regulatory requirements
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