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Complete remote FAT during the worst moment of the covid 19 pandemic
- By Emmanuel Colón
- / octubre 7, 2021
Overview
When the Covid-19 pandemic started around March/April 2020, our client AstraZeneca- a global, science-led biopharmaceutical located in Mount Vernon, Indiana- needed to complete a Factory Acceptance Test (FAT) for a Bottle Labeler machine for a new bottle line that was needed to meet market requirements. The Bottle Labeler machine will be in the new line Secondary area, and it will print, serialize, inspect, and apply labels and leaflets to the bottle. A FAT is a process that evaluates the equipment during and after the assembly process by verifying that it is built and operating in accordance with design specifications.
Our Client: Pharmaceutical Company in the USA
Roles
Validation Engineer
Deliverables
- Factory Acceptance Test (FAT) Protocol
- FAT Remote Execution
- FAT Summary Report
- Requirements Traceability Matrix
The Challenges
- Traveling outside the state was not an option due to Covid pandemic.
- FAT execution couldn’t be delayed due to project schedule constrain to meet market requirements.
Our Intervention
Ultimate Solutions proposed to execute the FAT remotely and thus prevent delays in the project.
- The strategy was outlined and discussed with the site management.
- The protocols were created so that they could be executed by the supplier and verified by us via Zoom meetings.
- The tablets and smartphones used as video cameras were tested days before the execution began to prevent any problems.
- During these tests, the positions of the cameras were established.
- During the execution, we made sure that the way it was being executed was the one established by the client. Documents were completed and approved on time.
Technologies
- Tablets
- Smartphones
- Zoom Cloud Meetings Software
Successful Results For The Client
- A new way for equipment validation was developed.
- FAT execution was successfully executed.
- Project was able to continue without major delays in schedule.
- No traveling expenses were incurred.
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