Laboratory Information Management

In CMS, received and manufactured materials that use lot numbers are created with a status of Quar (quarantined).
Quarantined materials may not be sold or used in manufacturing without being fully or provisionally approved.

The test and release of materials are organized by sublot.
Any received or manufactured Sublot may be Approved if all required tests have been performed and passed against that Sublot.
Tests can be specified for a particular item, as well as in a batching recipe.

As your inventory ages, you may also need to retest the Sublot to allow it to continue to be used.

Below are some major features of the LIMS package:

Test Definitions

Tests may be defined and specified as required for items, on either receipt or manufacture. Tests can be defined as Numeric, Boolean, String, Purity or a special type called DONE

Timed Testing In Package Execution

Often times tests must be performed periodically during package execution. These tests include things such as torque and fill weights. With CMS, these tests can be defined to auto occur at timed intervals.

Test Groups

Tests can be organized into test groups, with each group specifying the sample container. These sample containers have a default weight associated with them. CMS is so particular about inventory control, the weight of the sample container is deducted from the source containers from which it was derived.

Sampling

Sampling can be done by lot, batch or variants of square root +1. Generally speaking, the source containers to be sampled are randomly chosen. With another sampling type, one can specify the source containers to sample from and also weight the sample container for an exact weight. This is particularly useful where the item might be a schedule 2 drug.

Stability Testing

CMS supports stability testing with timed results entry.

Retains

CMS can enforce the sampling and storage of retain samples. In fact, CMS can be optionally configured to require a retain be located in a retain location before the sublot can be released.

Provisional Release

Within item specifications, some tests can be marked as deferrable. This means that the item can be dispositioned as provisionally released even though not all of the tests are complete. A typical deferrable test would be micro. A provisionally released sublot may be used for an order, but that order cannot be released / dispositioned until all of the items that went into it have been fully tested. Orders can include manufacturing orders or even sales orders.

Copying Tests

With just a few mouse clicks, tests from an item may be copied to many items. This is particularly useful when first setting up a system.

Final In Process Testing (FIPT)

Special tests can be defined for manufactured items whereas these tests automatically get added as a final ‘in process test’ to the end of a batching order. Tests can also be defined throughout the manufacturing process, though these are not what we consider to be FIPT tests.

Retesting Inventory

With the CMS sublot set viewer, expiring materials are readily visible. CMS can create samples for items that have not yet expired but will need to be re-tested shortly.

CofA Generation

CMS can generate CofA documents for any sample set that has been created and dispositioned.

Tests Results Set Viewer

One place where all of your test specifications and results can be seen by item, lot, etc.
Once there, you are able to sort and group on any field. With that, trends can be detected. Other statistically significant data can also be extracted from this grouping of information.

CMS

CMS Regulated

Recipe Manager

GHS Auth