Operational productivity and quality monitoring: An integral part of PV operations

Operational productivity and quality management system is an integral aspect of any pharmacovigilance (PV) operations team which is dealing with the dedicated end to end ICSR case processing activities. Operational quality and operational productivity management system is also an important part of the performance management system which involves tracking of the quarterly, half yearly, and yearly quality and productivity of whole ICSR case processing team with the perspective of annual appraisals.

The overall market reputation of any PV service provider is mainly dependent on the below parameters,

  1. Benchmarking quality standards of each ICSRs processed and continuous improvisation of quality standards
  2. Highly efficient and productive PV operations team
  3. Should be equipped deep expertise with perfectly trained resources for maximum output & efficiency
  4. Will be able to meet any client SLAs of productivity and quality without any hindrance

All the above-mentioned parameters and required for the consistent growth of any PV service provider. If the PV service provider successfully meets all the above criteria’s, it will ultimately result in the renewal of client service agreements and more trust gain from client for any additional responsibilities and at the end its overall market reputation of service provider will raise.

Need of an automated solution for operational productivity and quality monitoring

Resource wastage

Many times, additional resources were deployed for only tracking purposes for the quality and productivity of each user in the team which will result in more costing and more amount of manual efforts with more time consumption.

Meeting service level agreements

Every service provider abides to its Sponsor/MAH/Client for presentation of the monthly operational productivity and quality data of whole PV team, which is also a requisite of meeting the service level agreements (SLAs) of quality and productivity. Every sponsor/MAH has its own conditions of meeting quality specifications of each ICSR processed by the service provider, if service provider will not meet the projected SLAs as per agreement the it will eventually result in loss of the projects/clients and leads to loss of jobs.

Meeting PV audit/inspection compliance

Availability of accurate user specific productivity and quality data is very much important at the time of on-site audit or inspection conducted by sponsor/MAH/regulatory agency. It is the responsibility of project heads to present the requisite data on an emergent basis to the auditor/inspector at the time of audit/inspection. Many times, they fail to produce a valid and accurate quality and productivity which leads to a major audit finding and results in a serious process deviation.

As it is very much important to produce an accurate quality and productivity data of PV operations team by utilizing less resources and time. Hence, there is an immense need of an efficient automated solution which will consume very less resources and time and will provide an accurate and optimized data output.


Sarjen’s PvEdge offers an efficient 1st in class solutions for the monitoring of quality and productivity data of the specific user within the defined interval of time as per various requirements.

The solutions are given below,

  1. Operational productivity monitoring:

User specific productivity can be easily fetched with help of Workflow efficiency module of PvEdge.

  • It offers client specific segregation of productivity data of the users who have been tagged to that specific client
  • We can easily get the productivity data (with all the safety case IDs) as per the workflow specificity i.e. from Basic user, advanced user, QC user, Med. Reviewer, and Submission user
  • Provides accurate audit trail data with respect to exact date and time when the case has been routed from one workflow to another
  • An efficient solution which can also be potentially used as a case tracking tool in order to track the cases in the respective workflows
  • It helps to identify the underperforming users in case of productivity via consistent tracking of case count with defined range of time of that specific user.
  • Productivity trend analysis could be done by using the graphical outputs/charts options in PvEdge for increasing overall team efficiency
  • Easy export option into MS-Excel for further data analysis


  1. Operational quality monitoring:

Globally with various prominent clients (service providers & MAH), an ICSR case quality (accuracy) can be measured in different ways, the major ways of measuring it are case level accuracy and field level accuracy.

PvEdge offers an efficient solution to measure both the case level and field level quality through its Quality check list module.

  • Provides output of overall user/case specific quality data in % for the cases processed by the data entry users
  • It offers client specific segregation of quality data of the users who have been tagged to that specific client
  • Quality tracking tool of PvEdge is a user-friendly interface designed for the QC users to mark the errors observed in the ICSR.
  • All the data entry fields were covered in the quality check list segregated in tab wise manner.
  • All the 327 fields of the database were mapped under the solution and segregated in different error categories as critical fields (denoted by 3), Major field (denoted by 2), and non-critical minor field (denoted by 1)
  • Additional free text field in QC checklist interface is provided for marking any additional remarks with regards to the field error observed while doing QC in QC checklist module.
  • We can easily get the user specific quality data report including Client name, safety case IDs, tabs and fields in which errors were observed, error category, name of QC user, and % quality for that case.
  • Easy tracking of no error cases for purpose of monthly volumetric analysis.
  • An efficient quality tracking tool for the identification of underperforming individuals of the team.
  • Quality trend analysis could be done by using the graphical outputs/charts options in PvEdge for increasing overall team efficiency
  • Easy export option into MS-Excel for further data analysis
  • Provides accurate audit trail data which shows when the case was processed by which user.
  • Can be considered as a potential backbone of quality matrix system with client perspective.

Globally ICSR case quality (accuracy) can be measured in different ways, the major ways of measuring it are below,

  1. Case level accuracy
  2. Field level accuracy

In QC checklist module, there is defined formula for mapping both of above quality aspects:

Cumulative case level analysis: 100-((Total error score x 100)/ (Total cases QCed x Total of reference score))

Where Total cases QCed= Sum of total cases with error and without error.

Field wise formula: 100 – [ (SumOfTotalErrorValue * 100) / (327)]

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