Site Acceptance Testing for Pharma and Biotech - Lifescience Technology Global

Checking System Performance

Following on from FAT, the Life Science Technology engineers will undertake Site Acceptance Testing (SAT) after all the site systems have been tested and validated.

We will check and confirm that the system works as expected in your environment and that it meets all user requirements. This involves checking the system's performance within the actual operating conditions it will face during regular use.

Our Process

Confirm utilities (power, water, air, etc.), environmental controls, and support systems are operational.
Ensure equipment is correctly installed according to layout, specifications, and P&IDs.
Verify availability of updated drawings, manuals, change control records, and calibration certificates.

Execution of SAT

Confirm physical condition, proper assembly, labelling, safety devices, and utility connections.
Test control systems, interlocks, automation, alarms, and user interfaces in the real operating environment.
Ensure performance aligns with defined operational parameters and process requirements (e.g., flow rate, temperature, pressure).
Integration Testing - verify connectivity and interoperability with existing systems.
Confirm validation of software components, data logging, security, audit trails, and backup systems.

Documentation

SAT Report - Record all results, deviations, corrective actions, and conclusions.
Deviation Management - Document non-conformances and implement corrective/preventive actions (CAPAs) as needed.
Certificates - Include updated calibration, conformity, and qualification records.

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