Data integrity in laboratory equipment
We ensure compliance with the ALCOA+ rule.
Ensures data integrity compliance
Currently, most of the equipment used in drug monitoring laboratories is supported by computerized solutions integrated into the device itself or connected to it to obtain results or process the data generated.
Data management should be considered as a process in itself, not as something subsidiary to each operational process.
It must focus on the entire life cycle of the data, from its generation through its selection, representation, storage, retrieval, distribution, and use; regardless of the format or medium in which it has been recorded, processed, archived or removed.
Computerized systems that manage processes considered to be critical must comply with the ALCOA+ rule.
- The complete definition of computerized systems: an inventory of equipment and computerized systems (defining the industrial components, hardware and software involved) and diagrams of system operation and information flow (describing the intended use of the system).
- Strategy for validation and execution of qualifications.
- Maintenance of the control status.
To be able to prove in a documented way the correct integrity of the data of the computerized system. Taking into account as a computerized system the whole set of components that in an integrated way operate to manage a process.