stability lab information manager software by stability professionals, for stability professionals
Post on 01-Apr-2015
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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
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