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| Stability Module |
| Stability and
Shelf-Life Analyses |
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The following are features and benefits of Sapphire™ that address the specific needs of stability and shelf life testing:
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Support for a variety of conditions within a protocol,
including freeze/thaw. |
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Storage management that permits definition of the
physical storage system (chambers) and
environment, and easily shows free vs. occupied
locations. |
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Inventory management that, at any point during a
study’s lifecycle inventory, shows current and
required inventory, as well as flags when required
inventory is less than current inventory. |
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Study management, including automation of study
creation and start date, and special calendar
provisions for recurring events or holiday exclusions. |
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Work Order Management that tracks the status of
tasks assigned to individuals. |
| Setting Up a Protocol or Study |
Specifically, Sapphire accounts for the following requirements in a stability protocol:
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The nature and intended use of the product |
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Package/component material description and source |
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Method of manufacture/sterilization |
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Description of the type, size, and number of batches |
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Placement and orientation of unit storage |
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Storage conditions/parameters |
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Time-points where analysis will be performed (e.g. baseline, 3 months, 6 months, etc). |
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The number of duplicate samples to be created |
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Analysis specific to the attributes and uses of the product, including package integrity, pH, sterility, toxicity, weight loss, and chemical content/potency |
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Acceptance criteria |
The
Sapphire Stability Module:
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Enables automatic, configurable assignment of studies |
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Captures study justification |
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Tracks study status that automatically changes with the conclusion of the study. Statuses include Running, Suspended, Completed, or Cancelled |
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Can flag studies that have been modified by addition/subtraction of time points and/or conditions. |
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Allows the quantity of samples per sample pull to be entered so that the tests may be completed. |
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Allows the actual quantity received for the study to be specified |
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Provides the ability to adjust the quantity by whole percentages that would increase the required quantity to account for the possibility of retesting during the study |
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Provides a theoretical "available quantity" that is determined by subtracting the quantity required for testing from the actual total quantity submitted |
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Tracks the quantity put in each chamber location for a study |
In particular, Sapphire
provides the ability to:
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Schedule automatic sample logins based on the protocol’s selected time points |
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Track a sample once it is logged and the time it takes to complete testing |
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Notify designated person(s) if the time to complete testing is greater than the predetermined testing period. |
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Reconcile holiday "pull" decisions |
The Sapphire Stability Module enables organization to:
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Identify batches, sub-batch by lot #, location and date |
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Provide full traceability on finished goods to sub-lot level |
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Ensure FDA 21 CFR Part 11 electronic signature compliance, with audit history |
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Access the solution remotely (virtual user) via a browser - no Citrix required |
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Create multi-tiered and nested specifications |
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Integrate barcode labeling |
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Seamlessly integrate robust reporting |
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Create ad-hoc samples with and without formal requests |
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Highlight early warnings and real-time non-conformance |
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Monitor quality incidents |
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Enter different styles of results, including single sample and multi-sample |
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Review/edit samples at login including: actual collection date versus scheduled, test parameters, due date, priority, etc. |
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Check against multiple sets of specifications |
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Check against process/regulatory limits |
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