Installation

It is PV Zoom technical team is responsible of illustrating how to use the program & ensure user ability to use it.

During data entering

Validation during data entering by Users

• PV Zoom provides guiding messages for PV team (software users ) to validate the type of data entered & avoid moving to the next screen unless main data in the screen is entered.
• Dates will be selected from calendar.
• There four types of views to view data: (View Kanban, View pivot, View graph, View list).
• Most fields are dropdown lists.
• Texts boxes are fields that the user will write freely.
• Each user can choose the language.
• The system can add follower to follow up with users.
• Users can make chats with each other.
• There is a log file that can display all changes made to ICSR and you can also write a message or notes as guide for yourself.

Validation testing

Validation testing in the National Health Authority database used

Change control:

• Software change control:

➢ It is the responsibility of PV Zoom team & it is not allowed for the user.
➢ PV Zoom will release new version in case there is change that affect user.

• ICSR Change Control:

➢ version will be created by sending the case to EPVC.
➢ The user can create more than one version for the same case ID in case there is new data entered & finalized by sending it again.
➢ Case nullification will be an option for the user.

Nature of testing

It will be arranged with the company IT department however back up can be done automatically & customized according to company desires.

Back up procedure

It will be arranged with the company IT department however back up can be done automatically & customized according to company desires.

Security

• PV Zoom Flow will be accessed by QPPV/PV personal through user name & password & we can make restriction access for other users.
• In case there are more than one company related to the same owners or that is related somehow in business, PV Zoom can provide specific access to each company.

Duplicate Checking

Duplicate alert will be raised if the following items are matched more than once:

• Drug name.
  
• Event “MedDRA”.
• Any info about the patients.
  

Reports Generations

• Reports from patients or their representatives remain an important element in pharmacovigilance.
  
• Regulatory requirements, set forth safety monitoring and reporting responsibilities of sponsors and investigators to ensure the safety and protection of human subjects participating in clinical trials..
• PV Zoom can make tracking as the user needs that can be used also in KPI measurements.