1 / 17

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

connie
Télécharger la présentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related