Transcript No Slide Title

Stability Lab Information Manager
Software by Stability Professionals,
for Stability Professionals.
Software Highlights:
 21 CFR part 11 compliance features
 Validated according to FDA guidelines
 Available for Oracle and SQL Server
 Flexible calendar functions
 Effortless inventory management
 Secure data review process
 Shelf-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 tests
 Generates weekly testing schedules, long term
forecasts and late lists
 Highlights 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:
 There are 3 steps to the data process: entry,
verification, and approval.
 Data entry and
verification must
involve at least
two users with
Analyst security
rights.
 Approval of data
requires the
Supervisor
security right.
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 intervals
 Arrhenius calculations for accelerated data
 An example of 8 pooled studies
 Trend analysis
 Arrhenius Projection