Product purpose:

The main purpose of the system is to automate and enhance the efficiency of processes related to registration of medicines, namely, processes of registration, re-registration, amendment of the registration materials, expert appraisal of the materials of clinical trials, clinical audits, pharmacovigilance and other registry related processes. Upon implementation of the system, a centralized data base will be created, the information flow will be optimized and the following tasks will be fulfilled:

  • Standardization and systematization of information;
  • Efficiency and accuracy of information;
  • Confidentiality of information;
  • Integrity of information;
  • The accessibility of information for the users considering provided rights and control of access and amendments.

Scope:

The software product is used as a basic system for automation of business-processes at the state institutions in charge of registration of the medicinal products. The software can be also applied in cases when the processes of registration of the medicinal products are distributed between several agencies. For this purpose the system should be set up considering allocation of rights between the organizations/users.

Main benefits:

Comprehensive centralized software solution for automation and enhance of efficiency of the processes related to registration of the medicinal products:

    • A unified system will automate the processes related to the registration of the medicinal products within one company or in the group of related companies, if the processes are divided between them;
    • The system allows exchanging documents between the subdivisions of the organization or between several organizations;

 

Minimal costs for implementation of the system:

    • The system is centrally deployed on a server, server cluster or in virtual environment;
    • Implementation of system of any degree of complexity can be started immediately using a cloud service and transfer it to the corporate network;
    • A Web application allows working both with Windows and with MacOS, iOS operating systems;
    • Flexible functionalities allow to setup system without any programming skills.

 

Powerful processing platform provides fast and fail-safe operation:

  • Horizontal and vertical scalability of the system allows quick connection of new users and new modules;;
  • Modern architecture provides high running speed and reliable performance of the system.

 

Functional structure:

Subsystem

Description

Subsystem of registration and re-registration of the medicinal products

The main function of the subsystem is the maintenance of the registry of medicinal products and record keeping of the change history of the medicine data.

The subsystem provides the following options:

  • maintenance of the registry of applications for registration, re-registration or applications for amendment of the registration data of the medicine;
  • recording of the comments to the applications of the applicant, feedback of the applicant and additional materials provided;
  • linking of the applications to the contracts, payments made by the applicant and other entities of the system;
  • forming a package of the requests out of the group of requests by one medicine;
  • maintenance of separate registry of the instructions and brief descriptions of the medicines;
  • creation of the unified registry of the registration information of the medicines;
  • using special wizards with hints for quick creation of applications where one must fill out only key data.

Subsystem of clinical trials

The subsystem is designed for automation of the work on clinical trials.

The subsystem provides the following options:

  • registration of the applications for clinical trials and revisions to them;
  • recording of all the results of the clinical trials;
  • audit of clinical trials;
  • record keeping of the additional documents on safety of the clinical trials;
  • detailed registration of side-effects in the process of clinical trials.

Subsystem of approval

The subsystem is a flexible tool for agreement and approval of the decisions on applications.

The subsystem provides the following options:

  • agreement and approval of all types of applications;
  • creation of the draft decisions for each application, decision making;
  • creation of the printed forms of the approval results;
  • automatic change of the route of the application flow based on the decision.

Subsystem of the expertise and control over fulfilment

The subsystem allows to enter data on the expertise provided within the applications and to record the results.

The subsystem provides the following options:

  • maintenance of the registry of expertise by all the types of applications;
  • recording of expertise results;
  • flexible setting of the expertise types for tweaking of the system business-logic;
  • assignment of tasks for expertise, control over fulfillment of the tasks.

Subsystem of contracts

The subsystem is designed for record-keeping of the contracts signed with the applicants.

The subsystem provides the following options:

  • maintenance of the contract registry;
  • maintenance of documents related to fulfilment of the contracts: letters of guarantee, powers of attorney, payments, etc.

Subsystem of document flow

The subsystem allows automating of a wide range of tasks in respect of the documents flow of the company.

The subsystem provides the following options:

  • record keeping of the external correspondence;
  • of internal correspondence;
  • of official correspondence;

of the regulatory documents

  • work on the draft documents;
  • tasks and control modules;
  • maintaining of a completely paperless document circulation.

Subsystem of the material flow

The subsystem allows recording and tracking of the circulation of the paper-based materials attached to the applications and their electronic copies between the company subdivisions, archive or other key points.

Subsystem of pharmacological supervision

The subsystem allows recording in details all the side-effects of the medicines for the consequent review.

Dashboards

The subsystem is designed for convenient display (in dashboard mode) of the key data and statistics and their drill-down, if required.

The subsystem is available both for the managers and assigned persons

Notification

Subsystem supports the following ways of notification:

  • System message;
  • Email;
  • SMS;

The users can independently choose the events they want to be notified about by the notification message.

Administration and setting up

The subsystem provides a standard set of options of the system administration:

  • Allocation of rights to access;
  • Authentication;
  • Audit;

and setting up options:

  • Set up of logic registries;
  • Maintenance of the reference guides;
  • Printed forms, etc.

Cryptographic security of information and EDS

A software product has a built-in module of the cryptographic security of information used for cryptographic transformation of information (encryption, creation and check of the electronic digital signature, etc.).