REQ 294817 Clinical Trials Global Order Well

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DHL Clinical Trials

Global Order Well Requirements


CALIDUS Portal

20th December 2011 - 0.1
Reference: FS 294817












































Introduction

This document is the Global Order Well Requirements document.

Objective

The primary purpose of this document is to document the requirements gathered from DHL Clinical Trials, at Cherwell, on 9th December 2011.

This document has been written in a manner such that it can be approved by non-technical representatives of DHL Clinical Trials whilst also being of sufficient detail to allow the Functional or Technical Specification phase for this area to begin.

Scope and Limitations

  • This document is based on the documentation provided by DHL Clinical Trials, as referred to in the appendices, as well as information gleaned from the workshop with DHL Clinical Trials.
  • The changes will be made in the latest version of the CALIDUS Portal system.


Client Requirements

The business requirements are covered within a DHL document that has not yet been provided. This was reviewed by the OBS and DHL team on the meeting referenced above, along with a Concept of Systems screen prototype document.

The basic requirement is to allow access to basic inbound and outbound warehousing functions to satellite warehouse depots operating the Clinical Trials business, where they have no direct access to DHL's secure network and therefore the CALIDUS WMS system.

Functional Description

Inbound

A screen is required to update receipts.

The preadvice will be created in CALIDUS WMS by the Cherwell staff, either manually (for returns and direct supplier deliveries) or automatically (from Inter-Warehouse Transfers from the central Cherwell warehouse). The preadvice is created in the depot warehouse with Serial Number information.

A new screen within CALIDUS Portal will display a list of all available GRNs for that depot (warehouse). A number of filters will be available for the users to filter what is displayed:

  • A drop-down list of Studies (i.e. Owners) will be available to allow the users to see GRNs just for a particular study. Note that the Study list should show only studies with GRNs - this data is available from the Supplier field against the GRN.
  • A check box will be available to allow the users to elect to show all GRNs rather than just incomplete ones, only if the user has chosen to filter a particular study.
  • Filter boxes to allow the user to enter a specific GRN or Advice Note (matching anything close to the reference entered).

The filters will default to all incomplete receipts for all studies.

The screen will limit the number of preadvices displayed on the grid to a reasonable number (e.g. 20), with buttons to fetch the next/previous pages of data.

The details displayed for GRNs found will be:

  • Alert - showing whether a problem has been reported.
  • Inbound to be Processed - GRN or Advice Note number
  • Status:
    • Pending - Available for receipt
    • Complete - Receipt Completed
    • Error - an alert has been raised.
  • Expected Delivery Date
  • Return - If the receipt is marked as a Return in CALIDUS WMS, then this column will be checked.

Note that the operation also discussed a 'Ready To Use' column, but that this was rejected by the meeting, as the functionality had little use.

When a GRN has been selected, the system will display a details screen.

This screen shows header information for the GRN (as per the previous screen).

A detailed grid will show the detailed product information:

  • Product
  • Quantity
  • Batch
  • Sell-by Date

A Print button is available to print the Preadvice List - this will be a simple screen displayed within Portal showing the details against the products, and all the required serial numbers. The depot will print this list direct from their browser. Note Note: The prints throughout this document (Preadvice List, Pick List and Despatch Note) can be simple web lists, CSV extracts or PDF documents. If multiples of these types are required, this will increase cost.

The users will then receive the goods.

If there is any issue with the receipt, the user will report a problem by pressing a Report Problem button provided for this purpose. On pressing this button, the screen will display a confirmation dialogue, displaying the GRN information, requesting that the user confirm that they are reporting an issue. The user's name should be prominently displayed on this dialogue, ensuring that they are aware that they are responsible for this process.

Pressing No will return to the GRN detail form.

Pressing Yes on the screen will allow the user to enter details of an email. The Email recipient and some of the details will be pre-set on the form. On clicking OK, the email will be sent to the central contact email. The details of the email will also be saved in CALIDUS WMS on a new table created for this purpose.

The central contact email will be set up against the users' group within CALIDUS Portal.

Note Note: This Confirmation Dialogue will be used extensively throughout the product, whenever the user confirms data that will update CALIDUS WMS. This will ensure that the user is made aware of their responsibility when updating the system, as they will be tracked within CALIDUS WMS.

If a GRN has a problem identified against it, the GRN should be highlighted in the GRN select grid with an Alert icon against it. If so, this GRN can no longer be actioned by the Depot staff, but clicking on the icon should display the details of the problem reported.

If there is no problem with a GRN receipt, the users will press a button to update the GRN. Again, a confirmation dialogue will be displayed, showing the GRN details and the user name, as before.

If the user confirms that they wish to go ahead with the GRN confirmation, the system will create all pallets in their default putaway locations with all preadvised serial numbers received as if 100%. The screen will also mark the GRN as putaway confirmed. Standard processing (automatically holding the stock until the temperature has been confirmed) will remain in place.

When a supplier is going to send stock direct into the depots without routing through Cherwell, the Cherwell users will manually create a preadvice with all serial numbers. Once created, this will appear on the GRN list within CALIDUS Portal.

It was discussed that an email be sent to each depot, once per day, indicating the preadvices arriving in on that day. The meeting rejected the proposal, as this either encouraged lazy processes, or the messages will simply be ignored.

It was also noted that the Business Requirements Document (section 9.4.1) suggested that Carrier, Temp, Packaging and Monitor requirements were to be preadvised. The meeting decided that this was probably not required, but that this should be confirmed by the operation (Lukasz Danel of the DHL team to confirm).

SCR-294817-1: Create Portal Inbound Confirmation screen

Outbound

The order will be created in CALIDUS WMS and allocated by the Cherwell staff.

Any orders that have been created through the EDI process will simply be allocated by the Cherwell staff.

Any orders that have been manually entered by the Cherwell staff must be double-checked (to ensure that the Serial Number information has been keyed correctly). The process for this will be:

  • The order will be keyed by one user.
  • A second user will regularly show a list of all manually-entered orders at Entered status, through the standard CALIDUS WMS reports. The list will show all serial numbers entered against the orders.
  • For each order on the list, the user will check the serial numbers on this list. If they are correct, this user will then allocate the order and move onto the next on the list, until all are completed.
  • If the order's serial numbers do not match, the user will cancel the order and re-enter a new order with the serial numbers.

A new screen within CALIDUS Portal will display a list of all available orders for that depot.

A number of filters will be available for the users to filter what is displayed:

  • A drop-down list of Studies (i.e. Owners) will be available to allow the users to see Orders just for a particular study.
  • A check box will be available to allow the users to elect to show all Orders (included completed ones) rather than just pending ones, only if the user has chosen to filter a particular study.
  • A Drop-down List of Statuses will be available to allow the user to see Orders at that particular status.
  • A filter box to allow the user to enter a specific Order Number (matching anything close to the reference entered).

The filters will default to show all incomplete orders for all studies.

The screen will limit the number of Orders displayed on the grid to a reasonable number (e.g. 20), with buttons to fetch the next/previous pages of data.

The details displayed for Orders found will be:

  • Alert - showing whether a problem has been reported.
  • Order Reference - Order Number
  • Priority
  • Status:
    • Pending - Any orders at status Allocated or Pick Listed.
    • Picked - Any orders at status Pick Confirmed.
    • Packed - Any orders at status Pick Confirmed with Pack information entered against them.
    • Issued - Any later order status (Despatched, POD Confirmed, Invoiced, etc).
  • Selected - this will be a check box for the user to select which orders are to be actioned. There will also be a button above this column allowing the user to select all orders displayed on the grid. Note that if there are multiple pages of orders, only those displayed on the grid can be selected at the same time.

A number of action buttons will be provided to work on the orders selected. These buttons will be disabled depending on the status of the orders, as described below.

A Print button will be available. If the orders are at status 'Pending', this button will print Pick Lists for all the orders selected. Multiple orders can be selected when clicking this button. On printing pick lists, this button will update the status of the selected orders to Pick Listed, if they are not already at Pick Listed status.

The Pick List produced will be a simple list of the order information, followed by each product, then the Serial Numbers against each product. The Serial numbers will be displayed in the sequence in which they are held on CALIDUS WMS. A Watermark will be shown behind each page, showing that this list is for internal use only. The lists can then be printed directly from the user's browser.

If the orders selected are at 'Complete' status, this button will print a Despatch note for all the orders selected. Multiple orders can be selected when clicking this button.

The Despatch note produced will be a simple list of the order information, followed by each product, then the Serial Numbers against each product. The Serial numbers will be ordered ascending and displayed in this sequence. The notes can then be printed directly from the user's browser.

Note Note: If orders at multiple statuses are selected, all buttons will be immediately disabled - only orders at a single status can be processed together.

Note Note: If any order selected has an Alert against it, all buttons will be immediately disabled, as all processing of orders against with an alert will be completed through CALIDUS WMS by the Cherwell staff.

Note Note: If an order is selected that is not at Pending or Issued status, this button will be disabled.

A Pick/Pack Confirm button will be available. If the order selected is at status 'Pending', this button will call a Pick Pack screen, described later. Note that only a single order can be processed by this button - if more than one order is selected, the button should be disabled.

Note Note: If an order is selected that is not at Pending status, this button should be disabled.

A Despatch button will be available. If the order selected is at status 'Packed', this button will display a confirmation dialogue, showing the Order details and the user name, as before.

If the user confirms that they wish to continue with the despatch, the system will update the order to Despatched within CALIDUS WMS. The Despatched date and time will be set to the current date and time, and the user will be set to the logged-in user ID. Once completed, the Despatch note will be displayed (as with the Print button above).

Note Note: Only a single order can be processed by this button - if more than one order is selected, the button should be disabled. Note Note: If an order is selected that is not at Packed status, this button will be disabled.

A Report Problem button will be available at any status. If this button is pressed, this button will display a confirmation dialogue, showing the Order details and the user name, as before.

If the user confirms that they wish to continue with reporting a problem, the system will display a form to allow the user to enter details of an email. The Email recipient and some of the details will be pre-set on the form. On clicking OK, the email will be sent directly through the client's email program. The details of the email will also be saved in CALIDUS WMS on a new table created for this purpose.

Note Note: Only a single order can be processed by this button - if more than one order is selected, the button should be disabled.

SCR-294817-2: Create Portal Outbound Control screen

Pick/Pack Screen

This screen is used to capture the information regarding which serial numbers have been picked and packed into which cartons.

The screen will display some basic order information on the top of the screen.

The screen will allow entry of Air Way Bill and Carrier. Neither will be validated, other than they have been entered.

A grid will show all packs created for the order. Each pack created will display:

  • Pack ID - A unique numeric counter for each pack
  • Box Used - the Consumable Box Type used (the stock code and description)
  • TM Used - the Consumable Temperature Monitor used (the stock code and description)
  • TM Serial - The Serial Number of the TM used above.
  • Action - An 'Edit' button will be provided to edit the details entered if this data has not been interfaced back to CALIDUS WMS.

A New button will be available on the screen to add new packs to the order. When pressed, the screen will display an entry form with the following fields:

  • Box Used - the Consumable Box Type used. If WMS Packing has been enabled to require the entry of consumable box types, a drop-down list of all available box types will be shown here, showing the Code, Description and Quantity available). The user must select a box type from here.
  • TM Used - the Consumable Temperature Monitor used. If WMS Packing has been enabled to require the entry of consumable temperature monitors, a drop-down list of all available temperature monitors will be shown here, showing the Code, Description and Quantity available. The user must select a monitor from this list.
  • TM Serial - The Serial Number of the TM used above. If WMS Packing has been enabled to require the entry of consumable temperature monitors and the monitor type selected above requires serial number entry, a drop-down list of all available serial numbers of that monitor type will be shown here. The user must select a monitor serial number from this list.

Note Note: The Drop-down List of Consumable Box Types, Monitors and Monitor Serials may be displayed as a lookup screen instead. Regardless, the screen should account for consumable media used on this order.

Note Note: The information regarding which of the above have been used will not be interfaced to CALIDUS WMS until the order is confirmed packed. This means that multiple users may attempt to use the same monitor - this must be manually controlled by the operations.

A Save button will be available to save the new pack. A Cancel button will discard the new changes.

If the user elects to edit an existing pack, the entry form above will be shown, pre-populated with the data from the grid (including showing the pack ID). In this case, the same validation is applied as above.

Additionally, a 'Delete' button will be shown, allowing the user to remove the created Pack.

If detailed packing is required, the screen should only allow one pack to be created. If more are required, then a problem should be reported (directly from this screen), following the normal problem reporting process. So, if the user presses the button to add another pack on a detailed packing trial, a confirmation dialogue will appear explaining the issue. The user's name will be shown as normal. If the user elects to continue, they will be taken to the screen to enter the problem, an email will be sent and a problem message created. When complete, the user will be returned to the Order Select screen, where the order will be marked with an alert. Note: Only trials for UCB will be configured within CALIDUS WMS for detailed packing. All other trials will be configured for Pack level only and will be able to create multiple packs.

A Confirm and Cancel button will be available on the screen.

The Cancel button will discard all changes and return the user to the Order Select screen.

The Confirm button will display a confirmation dialogue, displaying details of the order and requesting whether the user wishes to continue with pick/pack confirmation for this order. The user name will be displayed on this dialogue.

If the user selects No, they will be returned to the Pick/Pack confirmation screen where they left it, with all data unsaved but intact.

If the user selects Yes, CALIDUS Portal will update CALIDUS WMS. The process will be as follows:

First, the order will be pick confirmed completely. The following data will be set:

  • User - will be defaulted to the user logged in
  • Date - current date
  • Time start - current time, minus 10 minutes
  • Time stop - current time minus 1 minute.

The Order Status will be updated to Pick Confirmed and all audit data maintained as standard.

Once this is complete, the system will save the packing data entered by the user and close the pack as complete.

SCR-294817-3: Create Portal Pick/Pack screen.

Reports

Several report requirements were discussed. The operation agreed to confirm all their reporting requirements would be able to be completed through the Oracle Data Extracts. If this was the case, then the Oracle Data Extract suite of reports would be made available through CALIDUS Portal, to allow the users to run their reports from there.

SCR-294817-4: Include Oracle Data Extracts within Portal.

If any reports are required that cannot be covered by this functionality, development of new reports within CALIDUS Portal will be required.

Optional Processes

Add Serial Numbers to Order Entry

It was noted that the operation may wish to allow specific users the ability to create preadvices. This is to allow for the use of this by the depot staff, when returns come direct to the depot or a supplier wishes to deliver direct.

In this case, the users require the ability to create a preadvice of the products and quantity of each to be received, specifying Batch and Sell-by Date information, and with all serial numbers entered. The Batch and Sell-by Date and Serial numbers will be validated that they are required for the product. If Serial Number entry is required, the screen will validate the format required by the operation.

SCR-294817-5: Amend Preadvice to allow Batch, Sell-by Date and Serial Number entry.

Note that this functionality will be specifically enabled or disabled through the user account, by adding the menu to the users requiring this functionality, so that specific users can be denied the Order Entry functionality.

Handing Problem Items Back to the Depot

The operation confirmed that the process of handling problems was that the processing of the problem item would be handed back immediately to the Cherwell team. However, it was noted that it may be required to hand the processing of the problem item back to the depot, once the problem is cleared.

When an issue reported for any process, the Portal users cannot continue until the problem is resolved. Therefore the messages created must have a 'Resolved' flag against the message. Screens must check for a non-resolved problem message against an item to stop it being processed through CALIDUS Portal.

It would be necessary then to allow a higher security level user (i.e. a supervisor) to amend and clear problems raised against the order or preadvice.

This can be achieved be amending the screens created above so that, when the messaging icon is clicked against an order or preadvice and the messages are displayed, the supervisor would be given the option to click a flag to clear the message, and apply a comment against it to confirm that it is cleared.

Alternatively, a new screen can be created that allows the user to see all messages, filtering by Order, GRN or Message Status, to clear any messages raised in one screen.

The Inbound and Outbound screens will also be modified to indicate whether the item has un-cleared problem messages (for example, with a red background) or whether all the problem messages have been cleared (for example, with a green background). Items with only cleared messages will allowed to be actioned by the screens.

SCR-294817-6: Implement Supervisor Message Handling within CALIDUS Portal

As an extension of this functionality, it should also be possible to email the user that raised the original problem message, identifying that the problem has now been resolved. In order to achieve this, it will be necessary to allow the users set up in CALIDUS Portal with an email address. When a message is cleared by a supervisor, the same messaging process used to send the original message can be called to send this resolution email.

SCR-294817-7: Implement Problem Resolution emails within Portal.

Messaging Functionality Within CALIDUS WMS

The message handling processes could also be implemented within CALIDUS WMS as well, allowing for users of the WMS product to clear messages and send emails, as described above in both SCRs.

SCR-294817-8: Implement Supervisor Message Handling within CALIDUS WMS.


Appendix A: Table of SCRs and Ballpark Estimates

SCR#SystemAreaDescriptionEstimate (Days)Notes
1 Portal Inbound Create Portal Inbound Confirmation screen  0.00 
2 Portal Outbound Create Portal Outbound Control screen  0.00 
3 Portal Outbound Create Portal Pick/Pack screen.  0.00 
4 Portal Reports Include Oracle Data Extracts within Portal.  0.00  2
5 Portal Inbound Amend Preadvice to allow Batch, Sell-by Date and Serial Number entry.  0.00  3
6 Portal   Implement Supervisor Message Handling within CALIDUS Portal  0.00  3
7 Portal   Implement Problem Resolution emails within Portal.  0.00  3
8 WMS   Implement Supervisor Message Handling within CALIDUS WMS.  0.00  3,4


Notes:

  1. Any high level ballpark estimates for development are based on the basic information provided, are provided as-is and are subject to detailed design and creation of an SCR. All estimates include Design, Specification, Development and Testing.
  2. This assumes that all reports required can be produced through the Oracle Data Extract suite. If other reports are required, further changes will be required incurring further cost.
  3. These items are optional and are not required to fulfil the core business requirements.
  4. This development can be used to replace the previous 2 changes, or can be completed as well.


Appendix B: Document References

B.1 References

Ref NoDocument Title & IDVersionDate
1CoS111209.xls09/12/2011


B.2 Glossary

Term Definition
CALIDUS Portal A suite of web tools designed to provide a limited functionality within particular CALIDUS products. The terms below describe the tools available. Comprises core portal functionality, plus modules - see Portal WMS, Portal TMS, Portal TTM, Portal Gateway.
Supplier Portal A suite of tools for CALIDUS TMS, for creation of orders, labels and load building. See Portal TMS.
LOTS Live Order Tracking System. See Portal TTM.
CALIDUS Online A suite of tools for CALIDUS WMS, comprising Preadvice creation, Order Creation, Enquiries and Reports. See Portal WMS.
CALIDUS WebOrdering Specific CALIDUS WMS tools for the creation of orders by sales teams, from specific product catalogues. See Portal WMS.
CALIDUS Portal WMS Specific Portal module for functionality relating to CALIDUS WMS.
CALIDUS Portal TMS Specific Portal module for functionality relating to CALIDUS TMS.
CALIDUS Portal TTM Track and Trace Module. A system fed by multiple other systems (including other CALIDUS systems like TMS, WMS, EPOD, etc) that provide a full track and trace of an order throughout its lifecycle, plus tools for light CRM/event management, and end customer tracking tools (through Gateway).
CALIDUS Portal Gateway A simple front-end to view track and trace information against an order. Usually provided through an emailed web link to the end customer.


B.3 Authorised By


Phil Harding

OBS Representative
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Asa Tilley

DHL Representative
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