One of the most common failures cited by FDA inspectors in Warning Letters is the…
- Like MPRs, BPRs now have a “view only mode” of their Manufacturing Instructions. This “view only mode” appears after the BPR has been Reviewed, Rejected or Added to Inventory.
- Each Manufacturing Instruction step in a BPR is “locked” whenever the Manufacturing Instruction step requires a signature and it is signed. When the step is “locked”, the data is no longer modifiable unless the step is “unlocked” by aQM, PM or PS. A history of those locks/unlocks are kept on each step.
- Raw Materials, In-coming WIP and Other materials used in manufacturing can be added to Projects allowing for Requisitions to be created based on Project as well as grouping all the inventory by Projects.
- Whenever a Deviation is added on to a BPR manufacturing step and is approved by a QM, an explanation in relation to the approval is required and the explanation is added to the signature history for that step.
- The BPR Manufacturing Instruction screen (TBPRManufacturingInstructions) has been redesigned to improving speed, to reduce the size on screen and to accelerate the capture of signatures. This later feature will prevent digital signatures from being partially captured when users have slow internet connections.
- Two new fields where added to the BPR Cover page called, “Planned Production Date”, and “MTO Batch Size” (Make to Order Batch size). Both can be edited until the Batch is Issued. Only PM, PS and QM roles can edit the BPR Cover page. In addition, the “MTO Batch Size” can be referenced by the Dynamic Fields on any Manufacturing Instruction Step.
- A new Filter was added to the BPR overview page where you can filter by date range based on “Planned Production Date”
- Any type of file can now be attached to each Specification.
- In order to better reflect the handling of inventory, now you can create records of a Material Usage with a zero (0) amount (except when using Inventory from inside a BPR Manufacturing Step). This will facilitate capturing reconciliation and inventory auditing information.
- When a file was attached to BPRs Manufacturing Instructions, you couldn’t move automatically to the next step.
- Under certain circumstances the system didn’t allow a batch to be Issued even when it had the material under the proper status and had enough in stock.
- When a user that already approved a BPR was removed from the project, sometimes the system didn’t allow the rest of the users to sign off on the BPR.
- When creating a requisition and selecting the Material to requisition, the system was showing all the material types instead of filtering out FG and oWIP.
- When comments were added to the Inventory Import Spreadsheet, those comments where shown in the Status Comment instead of the Receipt Comment.
- Minor spelling corrections.