The Process of Laboratory Work Defining the Need

Figures 12.2 and 12.3 show the flow of work in a typical laboratory. The existence of a model such as this is a key element in the development of validation plans since it provides an overall

' Sample/ Specimen Return

Sample Handling

Instruments & Evaluators

Working with Knowledge, Information, Data

Detail of one of a number of possible parallel paths, one per test Test 1

Sample Storage Management

Sample Storage Management

Test 2

Test 3

& LASF 1992

Figure 12.2

This figure illustrates the process nature of laboratory work and the relationships that must be included as part of a validation program. This figure is used with permission of the LASF (a non-profit foundation).

Test/Observati ons Reviewed may cause tests to be re-run authorize release of data, or change in direction of research

Instrument Control

Communications

Sample Login Event

Enter sample information, schedule test/study

©LASF1992

Figure 12.3

This figure shows the same process as 12.1, but includes the events that make the process function. This figure is used with permission of the LASF

structure for laboratory operations (showing the relationship between functions). An outline for required standard operating procedures, includes communications between components as part of the system (either electronic or manual), and, helps define the context for a statement of need.

The trend in laboratory automation implementation is toward "integrated systems" - following the same direction as commercial applications in office automation. The model shown in Figs. 12.2 and 12.3 can be used as the basis for designing integrated systems. The model is intended to be implemented in a modular fashion. Each module should be validated/qualified as should its communications link both upstream and downstream from it in the process flow. This adds work to the development of a validation plan. Laboratory automation programs in which each element (data acquisition system, robot, LIMS) is treated as an independent entity (no electronic integration), validate/qualify those elements with separate validation programs. The structure (Figs. 12.2 and 12.3) includes that work, plus the need to validate the connections between systems - something that should be required for the communication between any processes whether that communications is electronic or manual.

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