Life Sciences Quality Control & Assurance provides extended item sampling capabilities following a risk-based approach, in agreement with GAMP 5.
Item sampling capabilities in Life Sciences Quality Control & Assurance include:
The definition of the sample unit, if different from the released product inventory unit.
The calculation of the number of sub-batches to be sampled, and the amount of material to be taken from each sub-batch.
The number of samples and their quantities based on the total quantity received/produced or the number of sub-batches to be sampled.
The definition of sample quantity by analysis type. This allows companies with different laboratories to identify the specific quantity to be consumed for the execution of each laboratory test.
The possibility of reducing the needed sample quantity in case of reduced testing.
The possibility of defining if the sample quantity does not need to be blocked in inventory (that is, physically reserved) against an open quality order.
The type of sample(s) to be generated and whether the sample quantity must be traced in the system as available on-hand after the sample preparation.
The item sampling calculation is defined in Life Sciences Quality Control & Assurance > Setup > Quality Control > Item sampling.
It is possible to assign a sub batch type to each item sampling to identify the type of sample (for example, Retention, Identification). Users can select a value in the Sub batch type field in the Sampling quantity FastTab. In case of "Advanced" quantity specification, the Sub batch type can be assigned to each line in the Advanced item sampling form.
Additionally, after setting up item samplings, users need to define the test groups where the item sampling is applicable. This can be done by selecting an item sampling from the Item sampling dropdown menu in the Test groups form (Life Sciences Quality Control & Assurance > Setup > Quality Control > Test groups), or it can be selected when creating a quality association in the Quality association form (Life Sciences Quality Control & Assurance > Setup > Quality Control > Quality association).