Download - Stability Lab Information Manager Software by Stability Professionals, for Stability Professionals
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Stability Lab Information ManagerSoftware by Stability Professionals,
for Stability Professionals.
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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
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Main Browser
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21 CFR part 11 Compliance Features:
Each user has a unique login name and password
Timeout procedure
Prompted password expiry
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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...
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Calendar Functions:Multi-laboratory scheduling of testsGenerates weekly testing schedules, long term forecasts
and late listsHighlights scheduled pull dates that are late
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Inventory Management:
Chamber contents can be viewed instantly
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Inventory Management (cont):
SLIM easily manages various inventory transactions, such as storing, discarding, and transferring stability samples.
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Protocol Creation and Modification
Flexible protocol design features
Calculates the number of units needed for each storage condition
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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.
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Data Review (cont.):Data is entered, verified, and approved
on the LWR (Laboratory Work Request)
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Formulation Database:Ability to track formulation composition for
each new formulation
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Formulations Database (cont.):Batch Record - Ability to track individual lots of
ingredients for specific batches
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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
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An example of 8 pooled studies
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Trend analysis
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Arrhenius Projection