Impact of digital transformation on Pharmacovigilance (PV) operations

The pharmaceutical industry is set to embrace transformation initiatives at a faster pace over the coming years, across clinical, regulatory and safety practices. In product development, companies are focused on streamlining end-to-end processes to speed time to market and maintain regulatory compliance at all times. Pharmacovigilance being a highly regulated domain, requires careful planning and management during this time. There are many pain areas in the day to day PV operations for which the service providers are using traditional techniques like maintaining the data in larger excel sheets and word documents, no workflow or lifecycle management for the word documents for some important PV processes like aggregate reporting, Case processing & management, training and SOP management, deviation and CAPA management, quality and productivity management etc. We have divided the PV operations which can be completely transformed digitally in following ways where we save a lot of productive time of many PV operations teams,

• PV case management
• Aggregate reporting (PV reports workflow and lifecycle management)
• PV quality assurance activities & PV deviation and CAPA management
• PV training tracking and training file management

 

1. PV case management:

In many of the PV operations at service providers, still the case allocation, quality review tracker, case prioritization, case count matrix, case activity tracker & case reconciliation processes were managed manually on countless excel worksheets & hard copy documents manually, which are the main pain areas of every PV processes. Maintaining the accurate case relevant data in all those excel sheets and hard copy documents has become very difficult task for the assigned person who is handling day to day activities in huge amount of case volume. There is major possibility of manual errors may happen during these activities as no support from the database providers (PV solution providers) is not provided for the same. So, in order to avoid this hustle, there is an immense need of digitization of all those tracking sheets in the PV solution itself integrated into it. We at Sarjen systems developed some important automated modules in our PV solution “PvEdge^®” like,

• “Integrated case allocation system” for direct case allocation/reallocation to user registered in the system-that too client specific allocation, no need to maintain any excel sheet & hard copy document for tracking for the same along with case allocation case prioritization can also be done from the same module. It resolves all the manual issues and documentation aspects of case count matrix & case activity tracker.
• We have developed an “integrated workflow efficiency module” & “quality check module” for the user specific productivity & quality score calculations in the database itself without maintaining any sort of excel sheet & hard copies for the same. The same module can also be utilized for enhanced case reconciliation process, which is currently operating as a complete manual process in many of the PV operations.

 

2. Pharmacovigilance (PV) reports workflow and lifecycle management: (Aggregate reporting)

Currently the main problem with the aggregate reporting teams functioning at various PV service providers is that there is no defined workflow pattern and lifecycle management for various types of aggregate reports like PSUR, DSUR, PADER, RMP, Signal detection (SD) & ACOS. Still they are maintaining the hard copies of many supporting documents and mailing the draft documents manually within the teams for their respective review. There many manual processes carried out and their disadvantages as below,

• Manual drafting of the Draft PSUR or DSUR or RMP by Author
• In order to maintain the workflow once after the drafting the initial document the author needs to mail the document further to next reviewer or QC person/Medic review/QPPV review
• No tracking of how many reports were initiated for which drug molecule for which client, everything is done manually on Excel sheets
• No tracking of which report is lying in which workflow
• No audit trail compliance in manual processes
• No tracking & archival review comments added by the various reviewers at each step of reviewing the draft report
• No feasibility of prioritization of various reports as per regulatory timelines, no mail alerts to be fired for the same (e.g For PSURs alerts should be fired as per the respective DLP of the molecule)
• No pre-defined workflow of many of the reports like PSUR, PADER, SD, and RMP etc due to which there might be huge possibility of bypassing the workflow will happen due non tracking issues
• Non-compliance for Audits and inspections of aggregate teams
• No tracking of deviations & CAPAs
• There might be huge possibility of misplacing or data loss of manual draft aggregate reports while processing the reports which leads to a deviation
• Maintaining a record of supporting documents for submission of report is very difficult
• Authentication of reports at each review stage via wet signature only, there is no provision of digital signature while reviewing the reports for each reviewer
• Additional expenditure of multiple resources on these hard copies-oriented process which is much more time consuming and financially not feasible for any PV operations

We at Sarjen Systems have developed an efficient solution “QEdge: Controlled documents, workflow & lifecycle management” which is the best way to digitize all the manual, hard copy-oriented processes in the aggregate reporting teams in PV operations. It involves following limitless benefits,

• Efficient workflow and lifecycle management solution for aggregate reports like PSURs, DSURs, RMP, signal detection & ACOS
• 21 CFR part 11 compliant solution
• For each type of PV report respective workflow steps are defined in the solution as per regulatory compliance of GVP module VII
• All the requisite fields have been added in the solution which are fully compliant with GVP module VII
• Upfront masters for addition of Client, Client details or departments, product details, DLP or regulatory due dates
• Provision of creating multiple child record under one parent record for each type of report
• Fully compliant with Audit & inspection compliance as whole record of Audit trail can be tracked along with all the logs and reports can be extracted from the solution itself, no need to perform any manual task or no need to maintain any excel workbook for tracking
• Smooth movement of word draft of any PV report throughout the defined workflows in which the word document is completely editable and a user can also check the track changes
• Full fledge tracking for any of PV report (of specific client or molecule) to check in which workflow it is lying at that time, when it was routed into that workflow in the solution itself
• Tracking of exact no. of reports initiated for a particular client or particular molecules at dashboard functionality of QEdge
• Tracking & archival review comments added by the various reviewers at each step of reviewing the draft report
• Feasibility of prioritization of various reports as per regulatory timelines, no mail alerts to be fired for the same (e.g For PSURs alerts should be fired as per the respective DLP of the molecule)
• Feasibility of prioritization of various reports as per regulatory timelines & mail alerts to be fired for the same (e.g For PSURs alerts are fired as per the respective DLP of the molecule)
• No possibility of misplacing or data loss of manual draft aggregate reports while processing the reports
• Tracking of deviations & CAPAs through the review comments
• Maintaining a record of supporting documents for submission of report is efficient via document attachment functionality
• Authentication of reports at each review stage via digital signatures
• No additional expenditure is required for hiring more resources as whole process is digitalized
• Increase overall quality and productivity of the PV team

 

3. PV quality assurance activities (PV-QA) & PV deviation and CAPA management (PV-D & C)

PV operations involves various important activities like PV deviation and CAPA management & PV-QA activities like duty delegation, handover activity, note to file, change request form/change control & SOP management. Currently many PV service providers are conducting all above-mentioned activities manually, paper based, or mail based. Still they are maintaining the hard copies of many supporting documents (e.g. SOP documents & handover document) and mailing the draft documents manually within the teams for their respective review. These is no tracking of these activities and corresponding documents related to these activities. We at Sarjen Systems have developed an efficient solution “QEdge: Controlled documents, workflow & lifecycle management for PV-QA processes & PV deviation and CAPA management described above” which is the best way to digitize all the manual, hard copy-oriented processes in a single digital platform where whole lifecycle of that particular process is designed as per industry requirements and multiple fields were defined in the solution for creating a document digitally in the solution itself which will help to minimize all the manual paper based activities in the PV operations.

4. PV training tracking and training file management

Maintaining accurate training data for each resource hired in the PV operations is very difficult task. All the client and service provider specific trainings should be completed by the users and respective training record must be signed by the trainer and trainee both and the same hard copy document will be maintained in the training file allotted to that resource. In huge PV operations team (like more than 300 members) it is very cumbersome task to maintain the training files of each and every individual in the team and track the trainings completed by the respective users manually via mails. This manual & paper based process of training management will impact severely the training compliance of any PV operations team during the Audit or inspections when the Auditor or inspector may ask for any random training file of any associate and at the time audit if the file is found incomplete then it will become the deviation in training dept. Hence, we at Sarjen Systems developed an efficient training management solution (TMS) known as “QEdge-TMS” which offers multiple benefits to digitize every step of TMS which results in smooth and efficient operations of TMS. The benefits are listed as follows,

• Accurate tracking compliance of each associate specific trainings
• Separate digitized training record for each associate in the team
• No requirement of wet signature anywhere
• No requirement of maintaining any hard copy of training file of any associate, it will be maintained digitally in the solution itself
• Feasibility of digital signature for each trainee and trainer on the training record
• 100% Audit compliance during the Audits and inspections and availability of all the training records at one click as per Auditor’s demands
• No manual interventions are required in maintaining the training record
• Very much time efficient & saves a lot of productive time of the associate which can utilized in the important PV operations
• Accurate Audit trail data can be pulled out from the system
• Review comments from reviewer can be recorded for future reference