Stability Lab Information ManagerSoftware by Stability Professionals,

for Stability Professionals.

Software Highlights:

21 CFR part 11 compliance featuresValidated according to FDA guidelinesAvailable for Oracle and SQL Server Flexible calendar functionsEffortless inventory managementSecure data review processShelf-life projection and trending tools

Main Browser

21 CFR part 11 Compliance Features:

Each user has a unique login name and password

Timeout procedure

Prompted password expiry

21 CFR part 11 Compliance Features (cont.):Changes are recorded in event logs, with the date/time of the

change, name of the user, type of change, description of the change, user defined change control code and user comments...

Calendar Functions:Multi-laboratory scheduling of testsGenerates weekly testing schedules, long term forecasts

and late listsHighlights scheduled pull dates that are late

Inventory Management:

Chamber contents can be viewed instantly

Inventory Management (cont):

SLIM easily manages various inventory transactions, such as storing, discarding, and transferring stability samples.

Protocol Creation and Modification

Flexible protocol design features

Calculates the number of units needed for each storage condition

Data Review:

Data entry and verification must involve at least two users with Analyst security rights.

Approval of data requires the Supervisor security right.

There are 3 steps to the data process: entry, verification, and approval.

Data Review (cont.):Data is entered, verified, and approved

on the LWR (Laboratory Work Request)

Formulation Database:Ability to track formulation composition for

each new formulation

Formulations Database (cont.):Batch Record - Ability to track individual lots of

ingredients for specific batches

SLIMStat is a shelf-life projection software included with the purchase of SLIM

Data is sent automatically from SLIM to SLIMStat

Performs ANACOVA pooling of multiple studies

One-sided or two-sided confidence intervalsArrhenius calculations for accelerated data

An example of 8 pooled studies

Trend analysis

Arrhenius Projection