OpenRIMS - Follow–up Workflow

Motivation

Pharmadex 2 software tracks the lifecycle of medicinal products as well as facilities related to the import, selling, storing, and manufacturing of them. This lifecycle is managed by in-country businesses and the state National Medicine Regulatory Authority (NMRA).

The main stages of the lifecycle are:

1.      Registration or approval

2.      Active

3.      De-registered

To enter the first step, it is enough to fill out an initial application form and submit it to the NMRA.

For the entrance to the Active stage, the application should pass the initial registration (approval) workflow. It is an internal workflow on NMRA that typically consists of screening, review, approval, and finalization steps

In the second stage, it is possible to follow-up actions like renewal or inspection as well as modifications of the initial application data. Any follow-up action backed by an internal NMRA workflow.

This manual intends to help NMRA’s Supervisor build a particular follow-up workflow as well as decide how to schedule them in the Active stage of the lifecycle.

The Pharmadex 2 configuration knowledge is required.

Follow-up workflow

Application data

              The application data for follow–up workflow is the same as for the initial application. Thus, it is not needed to configure special application data.

Figure 1 Follow-up application data and workflow data

1.      Application data is the data of the initial application

2.      Workflow data is data that should be collected while workflow

Workflow data

              A follow-up application may collect additional data i.e., documents, schedules, registers, etc. Configurations of these data blocks should be created and included in configurations of the appropriative workflow’s steps.

              It is recommended to create all workflow data configurations before workflow steps.

Figure 2 Data that collected during the follow-up workflow finalization step

Workflow steps (activities)

              Any follow-up workflow should be defined as an item in the dictionary “dictionary.host.applications”.

Figure 4 An example of the follow-up  workflow dictionary

              The workflow steps definitions are similar to the initial workflow steps:

·       Screening

·       Review

·       Approve

·       Finalization

Figure 3 An example of a configuration of the workflow Finalization step

1.      URL of the workflow step configuration data

2.      URL for the workflow step checklist dictionary (mandatory)

Two steps are mandatory – Approve and Finalization.

The “Approve” step typically assigns a new certificate number. The “Finalization” step allows to generate and file the new certificate, as well as schedule the next follow-up renewal.

Scheduler

              The scheduler is an on-screen component that schedules the next run of any follow-up workflow.  In (MSH, 2022) the configuration of a scheduler is defined as:

Allows to run another follow-up application after the application will be approved. Examples are “scheduled renewal payment”, “scheduled inspection”, etc.

Figure 5. The scheduler component

Parameter	Usage	Example
Minimal Offset	Offset in months from the current date to the minimal possible date to run the follow-up application
Maximal Offset	Offset in months from the current date to the maximal possible date to run the follow-up application
required	the scheduled date should fit the Minimal offset – Maximal offset criteria
mult
Auxiliary Data
url	Where to store the scheduler?	pharmacy.site.renew
dictUrl
auxURL	Which application should be scheduled?	application.pharmacy.renew
readOnly	Display date only
unique
The pattern for the field or file names

Figure 6 The scheduled follow-up application will be shown in the Submit form on the Finalization step

1.      Approval action on the finalization step

2.      A list of the scheduled follow-up applications

A follow-up workflow may be scheduled once or repeated.

·       To schedule the workflow once, the scheduler should be placed in the Application data only

·       To schedule the workflow repeated, the scheduler should be placed in the Application Data and the workflow data.

References

MSH. (2022). Workflow configuration reference guide. Workflows Part 1.