workflow in pv-works · is when a case is saved as the system will prompt with all open 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”, Assured’s 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 process maps in
the first place
• Tasks may be active in parallel – and even can be assigned to the same person if appropriate.
• Loops may be created eg when a critical data element is not entered the process can return to
an earlier task to ensure completion
• The management function is more comprehensive, allowing supervisors to review the
workload of their team and re-balance it if necessary
• By linking tasks together and assigning “ideal execution time” to each, the total time available
from case receipt to report can be divided to ensure timely reporting.
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PV247 Workflow
All PV247 systems include a pre-configured workflow process implemented using the Pipeline
function described above. This is accompanied by three queries on the main screen that show cases
that are currently in one of three stages:
a) In Data Entry
b) Awaiting coding and assessment
c) Awaiting reporting
Timelines are set so that 7 and 15 day reports are submitted on time – if the user meets the targets set
by the workflow process.
The user is responsible for moving a case from one stage to another. The simplest way to achieve this
is when a case is saved as the system will prompt with all open workflow tasks:
Checking the box next to this task will make PV-Works complete the current task in the workflow
process and then start the next one (if any).
The workflow implemented for PV247 is deliberately simple – and is an over-simplification of a
complex process. Nevertheless it will help manage the flow of reports and can be supplemented with
ad hoc tasks as described above.
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For further details please read the brochure below or contact us
Assured Information Systems provides comprehensive solutions for human and
veterinary pharmacovigilance.
For more information please contact us:
Phone +44 1480 21 22 23 Email: info@assured.co.uk
www.assured.co.uk
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