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Stability Lab Information Manager Software by Stability Professionals, for Stability Professionals.

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

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Stability Lab Information Manager Software by Stability Professionals, for Stability Professionals.

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  1. Stability Lab Information Manager Software by Stability Professionals, for Stability Professionals.

  2. 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

  3. Main Browser

  4. 21 CFR part 11 Compliance Features: • Each user has a unique login name and password • Timeout procedure • Prompted password expiry

  5. 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...

  6. Calendar Functions: • Multi-laboratory scheduling of tests • Generates weekly testing schedules, long term forecasts and late lists • Highlights scheduled pull dates that are late

  7. Inventory Management: • Chamber contents can be viewed instantly

  8. Inventory Management (cont): • SLIM easily manages various inventory transactions, such as storing, discarding, and transferring stability samples.

  9. Protocol Creation and Modification • Flexible protocol design features • Calculates the number of units needed for each storage condition

  10. 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.

  11. Data Review (cont.): • Data is entered, verified, and approved on the LWR (Laboratory Work Request)

  12. Formulation Database: • Ability to track formulation composition for each new formulation

  13. Formulations Database (cont.): • Batch Record - Ability to track individual lots of ingredients for specific batches

  14. 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

  15. An example of 8 pooled studies

  16. Trend analysis

  17. Arrhenius Projection

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