- Engineering
- Commissioning, Qualification & Validation (CQV)
- Facilities & Equipment Qualification
- Manufacturing Readiness & Technical Transfer
- Engineering Change Control & Lifecycle Management
- Utilities & Cleanroom Systems Qualification
- Process Engineering & Scale-Up Support
- Automation & Control Systems (GxP)
- Equipment Reliability & Preventive Maintenance
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Automation & Control Systems (GxP)
Automation and control systems support consistent, reliable operation of manufacturing and laboratory processes in regulated environments. GxP automation systems must be designed, implemented, and maintained to ensure compliance with regulatory expectations.
Engineering oversight ensures that automation solutions align with process requirements, data integrity principles, and validation standards. Proper control system design supports operational efficiency while maintaining a validated state.
Automation lifecycle management is essential as systems evolve over time.
Automation and control system considerations commonly include:
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Control system design and architecture
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System integration and configuration
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Validation and documentation alignment
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Change management and lifecycle oversight
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Data integrity and access control