Product purpose:

The main purpose of the product is to create a national environment for the effective management and administration in regard to record-keeping of the medicinal products (MP), health care products (HCP), biological products, nutritional supplements, for control over their production, export, import and circulation, which allows to give a new level of higher quality to the management of the whole pharmaceutical industry, facilitate efficiency, reliability, accuracy and confidentiality of information.

Furthermore, the organization gets the following opportunities:

  • One-time input and consequent teamwork with the data; maintenance of data integrity and accuracy;
  • Significantly accelerated search of the medicinal products, HCP, etc. and related documents;
  • Suitable way of data storage and access for each MP, HCP considering all the changes;
  • Prompt receipt of the analytical and statistical data in the form of electronic and printed reports;
  • Enhancement of information security due to authentication of users when signing on, allocation of rights to access to information, audit of events and using data cryptographic protection facilities for data storage and transfer, etc.

Scope:

The software product is used as an enterprise system for documentation, certification, inspection, and audit related to MP, HCP, biological products and nutritional supplements, creation of electronic archive in organizations controlling the quality of MP and HCP. The system is used by the employees of the inspection authorities, including territorial one, on MP quality control, authorized labs for MP quality audit.

Main benefits:

Comprehensive centralized software solution for automation of the record-keeping and quality control of the medicinal and health care products:

    • A unified system will automate the processes related to the record-keeping and quality control of the medicinal and health care products within one organization or in the group of related organizations, if the processes are divided among 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

Accounting of permits

Maintenance of register of the licenses from the moment of registration of license application until its delivery to the applicant.

Analysis of the correctness and legitimacy of the reporting forms filled out by the entities in accordance to the types of the licensed activity, error diagnoses and applicants’ informing.

Maintenance of the service directories and catalogues to support electronic services with regard to data localization (including the registry of correspondence of the names of medicinal products to their international names in Latin).

Inspections and audits

Subsystem covers the process of inspection of the business entities engaged in production, storage, transportation, application, sales, disposal, and destruction of MPs and HCPs.

Maintenance of the list of audits and inspections, their status. Building questions for the audits depending on the activity of the entity.

Certification

Subsystem covers a process of certification of pharmacists and pharmacy technicians.

Control over MPs and HCPs

Control over inventory of medicines, drugs and psychotropic substances, control of the prices of the relevant categories.

Control of import/re-export and provision of MPs, HCPs to the welfare beneficiaries for a certain period.

An option to get information by the arbitrarily given parameters, including average and ceiling prices, prices for MP and HCP, etc., based on which the control is established from different perspectives, including countries, manufacturers, batches, licenses, residual stock, administrative-territorial division of the country, etc.

Monitoring and reporting

Informational and analytical processing of data for all subsystems considering communications, secure communications, search of trends in changes of the level of export/import/re-export of MPs. Prognosis of price levels, volumes of export/import/re-export.

Presentation of the received dependencies, prognoses, assessments in form of corporate standard reports, standard form of internal and external reporting, including graphic elements: graphs, charts, tables.

Option to set up an automatic preparation and completion of the reporting based on the given graph.

Document flow

Registration of the official documents: all types of licenses, import licenses for MP and HCP; GMP, PIC/S certificates, results of the lab tests, agreed technical regulations for production, MP certificates for international trade, case files, regulatory documents, references, verification letters, applications, etc. using EDS for electronic copies of the documents.

Support of making legitimate managerial decisions when buying, providing, returning, destructing of the batches of the special security marking elements; record keeping of the strict accounting forms.

Search of required registered official documents or forming a package out of available documents according to the list using random attributes.

Strategic management

Building of the strategic aims, their pursuit, changing, support as well as determination of rating for the territorial and structural subdivisions. Creation of planning charts, estimation of the level of achievements of the strategic aims under the ratings for the given period both in textual and graphical representations.

Contracts and settlements

Preparation, execution, record-keeping and maintenance of the contracts with the state companies, organizations, market entities (contracted clients) for System electronic services. Determination of commencement of work and tariffing of the contracted client under billing system according to the signed contracts for electronic services.

Billing of the contracted clients, control of the status of settlements with the certain contracted clients for the relevant period.

Official notification of the contracted parties on the current status of the debt under the contract with the references to the respective bills and payments as well as on change of the rates under the contract or billing procedures.

Administration and security

Subsystem of entitlement and control of rights of the users/user groups to access System resources:

Maintenance of accounts of users/user groups;Control of access to the copies of documents/elements of electronic cards;Control of access to the operations on cards, depending on card status too;Identification of users by login, authentication of users by password; Enable/disable a mode of operation logging by the document, electronic card.

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.).

Audit

Audit of the attribute value changes, operations of the basic electronic entities of System (user, time, old value, new value).

Audit of levels of the directories, operations on them.

Audit of the activated network services and list of their parameters.

Review and management of records received as a result of audit.

Web portal

Centralized environment for cooperation of the participants of global and local processes of the System which includes basic functions of the System with an option to control interactive services, such as: threads, surveys, forums, and subscriptions.

Representation of the basic information on the inspection, useful references to the regulatory documents and user's documents regarding work with the System.

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.