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Better PV Compliance with Automated Workflows

Pharma, Biotech, CRO and Life Sciences companies have PV as a mandatory regulatory responsibility. As there’s an exponential increase with the volume of Individual Case Safety Reports (ICSR) increasing every year it has become quite mandatory to design an automated solution for the largely manual pharmacovigilance process for these companies.

RPA based Dynamic Workflows – Prioritizes the cases based on seriousness

1. Workload Balancer – Usually the case assignments are manual where there is a need of a workflow manager who has to determine the complete load of every individual manually and assign the cases. Sometimes, he has to wait for someone to take up a case from the respective group.

Along with the manual case assignment option, Our Safety provides an Automated Workflow Manager which enables the system to determine the workload of every individual and assigns the cases to them based on their availability, current workload and capacity by examining their history of case handling.

2. Case Monitor – monitor for monitoring and reporting (sending auto-notifications) to the process groups/ workflow manager/ head of the department whenever there is any pending case from any group performing the processes is observed.

The feature allows the system to give intimation in the form of an automated email to the concerned personnel about the due dates and sends follow-ups if the case hasn’t been dealt with within the required time period. The feature also escalates the issue to the person in charge of the pharmacovigilance of that company. It ensures you don’t fail to complete any case due to uninformative reasons.

3. Traffic-Light Color Coding  – The PV system also comprises of automated traffic-light color-coding for providing an intimation about the status of any case.

There are three colors visible in front of every case. Green is referred to a case that is processed right on time, Yellow is for a case that is nearing its due date and Red is for a case that is already overdue and is yet to be processed.

 

 

The color coding makes it easier for the users as well as the administrator of the system to have knowledge about the status of their cases and help in a timely procession of each case.

 

The list of the color-coded cases is visible on a highly interactive customizable dashboard which makes the system excessively user-friendly. This list enables the users to be well aware of the status of every case they’re handling.

Automated Daily Report Generation – The system also has the ability to generate daily status reports on an everyday basis. The report provides an overview of the status of every case at each processing phase.

The status of the cases is available on the interactive dashboard. It also generates automated notifications in the form of emails which consists of information regarding the same. The report helps the users as well as other concerned personnel to stay updated about every case and the process it’s going through.