Slingshot Expands Features for Pharmaceutical Companies

Slingshot’s procurement, inventory management and manufacturing software includes lot control, lot genealogy, black listing and other functions required by GxP compliant manufacturers and laboratories.

The features listed below are available in G2-9.2 (released 6/26/17).  For more information contact Slingshot at sales@slingshotsoftware.com

Electronic Signature Required for All Inventory Transactions

The FDA in its 21 CFR Part 11 regulation requires electronic signature capture for all transactions affecting manufactured material.  A parameter now requires electronic signature for the following processes within Slingshot:
•    Receipt Completion
•    Material “Put Away” (inbound put-away confirmation)
•    Inventory Status Change
•    Inventory Balance Adjustment
•    Material Staging (for work orders)
•    Work Order Completion
•    Changes to Lot Information
•    Material “Pick Up” (outbound pick confirmation)
•    Shipment Confirmation
•    Material Sampling Confirmation
•    Physical Inventory Post (cycle count adjustments)
In each case above, the user is required to supply credentials before completing the transaction.  The application checks to ensure the user’s role permits the transaction.  The user and time/date stamp are recorded on shipment records and in the application’s inventory balance transaction log.

Sampling Workflow Implemented for Class 1 Material

The system now informs the responsible user (e.g. Quality role) when material requiring sampling has been received.  Sampling instructions are stored for each product.  The Quality user requests samples (specific containers) and a Material Management user is instructed to pull the samples and deliver them to Quality.  Quality draws the samples and indicates the samples have been drawn on the lot record.  The system instructs the Material Management to pick up the excess material and return it to stock.  When the testing process is complete the Quality user accepts or rejects the material.

Bill of Equipment Processing

Each manufactured product is associated with a bill of materials and a bill of equipment.  Component materials and serialized equipment is allocated to the work order in the work cell before the work order can be opened.  When the work order is completed genealogy records document the lots consumed.  Equipment tracking records document the equipment used in the process.  A “where used” inquiry provides a complete audit trail listing all work orders and manufactured lots using a specific lot of component material or a serialized piece of equipment.
Workflows are also provided for equipment maintenance.  The system prevents the allocation of a piece of equipment to a work order if it is due for maintenance.

Inventory Status Assignment Restricted by User Role

Slingshot retains a status on all inventory balances.  Valid statuses (unlimited) are set up in Slingshot.  For pharmaceutical customers, the status list commonly includes (Quarantined, Approved for Use, Released, Rejected, Held for Analytical Development, Held for Destruction, etc.).  Slingshot now allows certain statuses to be restricted by role.  For example, Quality users are normally the only users allows to apply “Released” and “Rejected” statuses.

Retest Date Assigned Automatically

Slingshot automatically tracks the expiration date for lot controlled material.  This date can be extended by an authorized user as a result of material testing.  Slingshot now automatically sets a retest date to a number of days before the expiration date.  An alert notifies quality when material requires retesting.

Improved Material Labeling

New label formats incorporating the Material Status have been developed.  The application provides convenient regeneration of labels when material status changes.  Label formats are specific to a unit of measure as well allowing different dimensions and information on “Case”, “Vial” or “Pallet” labels.