Workflow in PV- .Assured Information Systems ; Workflow in PV-Works Page 2 of 9 Query-based Workflow

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Assured Information Systems ; Workflow in PV-Works

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Workflow in PV-Works

Executive Summary

Fundamentally, pharmacovigilance is a business process. The steps through which a case should pass

from initial receipt to report can be defined, the conditions appropriate to each step are known and the

overall time goals are specified.

PV-Works provides process support throughout all of its packages the level of support varying with

the options selected:

All versions use in-built queries to track cases through key stages of the process

All versions only ad hoc workflow task function with coloured to do list to highlight lateness

Full workflow option comprehensive process management using a flowchart (or flowcharts) designed specifically for each customer

PV247 Essentials and Premium Packages include a simple built in workflow process and supporting queries that show cases in the steps of data entry, coding and assessment and

reporting. This uses the full workflow option but is pre-configured

These are described below.

Introduction

The pharmacovigilance process is complicated by the variety and quantity of cases handled, the need

to meet deadlines derived from both business and regulatory sources and the number of hands

through which a case passes from receipt to closure.

It is immediately recognised that the process must be controlled if temporal and quality goals are to be

met. But this process is no more complicated than others found in manufacturing, banking and other

business sectors where software already supports workflow management.

Process or workflow management is an integral part of a product safety system and one that must be

incorporated from the outset. Whether a fully functional workflow system such as that offered by PV-

Works as an option is necessary is determined by factors such as case volume, the desire to exert strict

process control in order to ensure quality and the complexity of the process itself.

Assured Information Systems ; Workflow in PV-Works

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Query-based Workflow

All versions of PV-Works include queries that support the tracking of process management. The main

screen of PV-Works has been designed as a query engine that stores any number of pre-defined

queries that can be executed and their results displayed in an Excel-like grid.

Query ListQuery Results

Included with all versions of PV-Works are queries that implement a basic process:

Cases that need to be coded Cases that need to be assessed Cases ready for reporting Cases that have been reported Cases where follow up has been received but not reported

The user can run each of these queries (or report) at any time and use the results as a work list. For

example, by returning a list of cases to be coded, the user may double-click each row to execute the

coding step and so remove the case from the worklist.

Highlight case in worklist Select "operation"eg MedDRA coding Perform task

Assured Information Systems ; Workflow in PV-Works

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In addition report are included that list cases due for submission and the performance of reporting to

a selected regulatory authority showing the percentage of cases reported on time.

(Note could find a better example where I had actually reported some on time!!!)

Enterprise package customers can extend this with by creating their own queries and reports to meet

local process needs.

Ad hoc workflow task function

In addition to the Query-based workflow function, Premium and Enterprise packages include a simple

workflow function where tasks can be created and assigned to individuals or groups of users. The

tasks can be set with start dates as well as target completion dates and so can be used to define a

simple process. Any number of tasks may be created for a case and several may co-exist in parallel. It

is also possible to set a task to yourself as a reminder, eg call hospital / vet in three days time to see

how the patient is recovering .

Tasks may be set at any point in the process or at any time either from the main screen of from within

the case itself.

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Icon

Apart from setting the person(s) to whom the task is assigned and its target date, the user may also

add a brief description of the task. This can be useful to explain to the task recipient the reason for the

request.

As the screen above shows it is possible to notify the task recipient that this task has been created.

This is a useful feature if this person is not a regular PV-Works user. However, all assigned tasks will

be displayed on the PV-Works To Do list which is another main screen query :

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Workflow queryTo Do list

As with the Query-based workflow example above, it is possible to highlight the task and execute

PV-Works functions for the selected case.

PV-Works uses a colour coding system to highlight the timeliness of task. A white coloured task is

on time; a blue task needs to be started now while a red task is late. The goal for any

pharmacovigilance team is to avoid any red tasks.

The advantages of the ad hoc workflow function over the Query-based workflow are:

The task remains on a to do list until it is completed A management function allows the task initiator to see if it was completed and when The task and its execution become part of the case record and can be reviewed at any time By defining tasks individually the function offers flexibility to handle any process / case

situation

Process-driven Workflow Management

PV-Works Premium and Enterprise systems can include Pipeline, Assureds workflow module

written specifically for pharmacovigilance and specifically for PV-Works.

In Pipeline, each customer defines their own business processes graphically as a series of process

maps that include rules for branching, task assignment, expected duration and escalation. Different

maps may be created for different case types or user groups as necessary.

Workflow maps can range from simple to complex:

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PV-Works determines which tasks are active at any one time and presents these to their respective

users as a to do list drawn from all processes in the database. Outstanding actions are colour coded

to highlight those that have priority or are overdue.

The to do list is fully integrated with the safety functions of the system. A user may click on any

action in the list and will be taken to the appropriate part of the system with the relevant data loaded

so that the action step may be carried out.

Upon completion of a task PV-Works determines which task or tasks should then be made 'active'.

The users associated with these new active tasks are informed immediately that they are ready for

action.

Compliance with SOPs is achieved as PV-Works follows the process map to determine each activity

and ensure that all necessary tasks are completed for an individual case.

Time targets, such as reporting deadlines, are closely monitored and the system informs the user of

the degree of any slippage.

For a workload supervisor or manager, additional functions are provided to monitor the current (and

future or past) workload of a team or individual. The supervisor may re-assign actions to other staff

to overcome bottlenecks or to handle absences (eg holiday, sickness).

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PV-Works collects and stores detailed data describing how each case actually progressed and how

each action step was performed (person and time). This provides metrics which can be used to track

performance for individual tasks, workgroups or individuals.

Pipeline is used by several of our customers with large case volumes to ensure that every cases is

processed in accordance with its SOP. Its value is increased for companies where staff from multiple

locations are involved in the process or even staff on different floors of the same building!

Running the Pipeline module does not mean that the ad hoc workflow has no place. Customers often

use Pipeline to handle the standard process and supplement this with ad hoc workflow tasks to

manage the unusual or one-off situations.

Assured recommends that new customers take the offer for us to design the first process map this

may in fact be the only process map your business needs. This offer includes a review of your

business process, design and testing of the Pipeline process and its implementation.

The advantages of process driven workflow function over the ad hoc workflow are:

Tasks are linked together so that when a task completes the system evaluates which task or tasks need to be created and then sets these running automatically

The Pipeline design function is comprehensive and includes decision points so that different rule may be applied to different cases as well as the option to create multiple pro