Services Laboratory and Process Equipment
Computerized systems used in control laboratory processes
Currently, most of the equipment used in drug control laboratories are supported by computerized solutions integrated into the device itself or connected to them to obtain results or process the data generated.
If the computerized system intervenes in activities regulated by the GxP, it must be validated. But should we focus on the computerized system or on the process it must manage? It is vital to avoid the traditional concept of qualification of equipment and computerized systems in a separate or poorly integrated way. We must identify the components that will provide the operation, security, engineering or technology that together will manage the process and verify that all of them, in an integrated way, operate according to the intended use.
Validation strategy
The validation of computerized systems has the main objective of providing documentary evidence that ensures that the computerized system works according to its intended use previously determined and approved by the organization.
The validation project is mainly divided into four major stages:
- Definition of the equipment and computerized systems present in the organization
- Validation project for critical equipment and systems.
- Maintenance of the control status.
- Removal and migration of systems.
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