Quality Management System (QMS)

The Quality Management System of our company was developed on the basis of a process management model and includes primary and auxiliary identified processes, as well as processes for managing the system as a whole and employs a risk-based approach.

The company’s concept of quality management, based on the international requirements listed above, determines the approach to quality management for customers' products stored and processed at warehouses of the company’s service providers, from the perspective of the products' life cycle.

The Quality Management System of our company fully addresses legal requirements (government requirements) that the Santens Companies must comply with in order to be able to carry out their business, as well as needs of consumers and partners, provided that do not conflict with the mandatory legal requirements mentioned above.

Santens Group of Companies identified the stakeholders relevant to its Quality Management System, as well as the requirements, needs and expectations of such stakeholders. Santens Group of Companies evaluates these stakeholders on a regular basis and monitors their satisfaction, identifying trends in how their needs and expectations are changing.

On the basis of results of such analysis, the senior management of Santens Group of Companies defines the Goals of the Company at annual strategic sessions, which include goals to ensure the compliance of the provided services and to increase satisfaction of the Customers of Santens Group of Companies.

We focus on four major elements of the management system:

• process monitoring and service quality system;
• CAPA management system
• change management system;
• analysis of the QMS efficiency by the company’s management.

• Process monitoring is performed using a set of performance indicators conforming with the SMART rules system.
• The Change Management System employed by Santens Group of Companies allows the company to make necessary assessments and approvals and implement significant changes based on assessments of risks affecting the quality of pharmaceutical products and the quality of services. This system ensures that continuous improvement is going effectively and according to a schedule and also provides a high degree of confidence that no implemented changes have any unplanned consequences.
• The CAPA management system is designed to eliminate the causes of identified and suspected non-conformities.

CAPA plans are developed on the basis of:

1. investigation of non-conformities;
2. internal audits;
3. external audits;
4. audits by the regulator;
5. KPI analysis and evaluation;
6. investigation of the causes of customer complaints;
7. evaluation of customer satisfaction.

The level of effort, formalization and documentation of the investigations is proportional to the level of risks affecting the quality of pharmaceutical products and the quality of services.

• Continuous improvement of processes and the quality of services is achieved by monitoring internal and external factors that affect the system. Such monitoring is part of periodic analysis performed by the management.

The range of services offered by Santens Group of Companies has expanded and significantly changed in the recent 2 years due to the implementation of the Track&Trace project in respect of pharmaceutical products in Russia.
In the recent 2 years, there have been the following trends in development and improvement of the QMS utilized by Santens Group of Companies:

• implementation of Data Integrity requirements in the QMS,
• as well as implementation of applicable requirements established by ISO 27 001 "Information Technologies. Security techniques. Information security management systems. Requirements" and requirements in respect of ensuring information security, raised by the Customer of Santens Group of Companies.

Santens Group of Companies keeps adopting new tools to automate its internal management and support processes, and also offers new IT tools and IT solutions to its partners in order to ensure compliance with mandatory requirements established by the government in respect of traceability of information relating to pharmaceutical products in the supply chain in the Russian Federation.

The company implemented such IT solutions as WTS and PharmConnector that allow the company to register information about serialized pharmaceutical products that are received at and shipped from the warehouses of Santens Group of Companies, as well as to register all transactions relating to the pharmaceutical products circulated in the warehouses and transmit the collected data about the serialized pharmaceutical products to the customer’s system for further submission to the MDLP information system by means of a special integration solution facilitating data exchange between the internal systems of Santens and the customer’s ERP.

Santens Group of Companies implemented an automated GLPI system to track IT-related incidents.

For the purpose of automation of internal training processes, the company deployed the WebTutor automated system that allows for remote internal training on training programs and modules, testing of personnel, as well as systematizing and keeping the company’s knowledge.

In the recent two years, Santens Group of Companies has been implementing a pilot project for adoption of Jira, taking into account the implementation of the Data Integrity requirements in line with the requirements of Pharma.

The Jira automated process management system as part of the Quality Management System allows the company to build management processes, such as non-conformity management (deviations, internal and external audits), control the execution of tasks — CAPA for nonconformities; generate Reports and evaluate performance.

All computerized systems used by Santens Group of Companies are evaluated by the Quality Management Department regarding their criticality (GMP impact), i.e. their potential impact on the quality of products, business processes and data integrity.

Santens Group of Companies is implementing validation projects. The integrator and the administrator of such projects is the Quality Assurance Department of Santens Group of Companies. The scope of validation tests for computer networks is determined for each specific computer network, taking into account the level of criticality of the system, the category of the computer network in terms of GAMP5, the system lifecycle approach and data integrity, and the applicable validation tactics are based on the assessment of risks of system failures.

The sustainable and successful development of Santens Group of Companies is achieved due to the ability to take into account all changes and adopt necessary innovations based on the knowledge and risk assessments.

Santens Group of Companies believes that knowledge management and quality risk management are the primary tools for improving the Company’s pharmaceutical quality system.

Knowledge management system

Santens Group of Companies identified the knowledge required to operate its business processes and to achieve the compliance of its products and services.

We organize the process of collecting, analyzing, accumulating and disseminating knowledge by the company’s personnel.

The knowledge of Santens Group of Companies includes:
• documents of the quality management system;

• results of external audits;
• training materials for internal trainings;
• training materials provided by external trainers;
• variousmarketingstudiesofthecompany;
• resultsofprevioustasks;
• experience of key employees — transfer of knowledge is effected through mentorship.

The Quality Management Department has the Training Center that organizes and administers a regular internal training system for all employees of the company involved in QMS, according to training programs approved by the company’s internal regulations, including mandatory annual GDP (Good Distribution Practice) trainings. Deployment of the WebTutor automated training system allows the company to organize training using special training materials and to evaluate the effectiveness of such training.

This systematic approach applied to the knowledge management:

• helps our specialists to use the acquired knowledge and skills to solve their professional tasks properly and according to their assigned responsibilities;
• promotes the development, acquisition and accumulation of new practical and theoretical knowledge by the employees, including knowledge related to specifics of storing, processing and transporting pharmaceutical products;
• allows for further professional growth of the employees in the company.

Santens Group of Companies analyzes risks and opportunities, both actual and potential, that may arise because of internal and external factors, and applicable requirements as part of the regular work of the company’s expert group which is responsible for identification, assessment and analysis of risks and for monitoring the implementation of the relevant risk minimization plan.

This means that all decisions are based on the accumulated knowledge and on assessment of risks affecting quality of processed products and rendered services.

The top management of Santens Group of Companies is actively involved in this work and is responsible for coordinating risk management between different activities and different subdivisions of the Company; it ensures that the quality risk management process is defined, fully operational and verified, and provides sufficient resources for risk management.

Such a proactive attitude of the top management allows the company to establish a basis for the continuous sustainable development of it QMS in compliance with mandatory external regulatory requirements and needs of the customers and also allows the company to build a solid foundation for its initiatives aimed at sustainable development.

The Company is aware that the main factor of success on the market is the quality of the offered services and all other activities of the Company.

The Company utilizes global experience to achieve these goals and improves its QMS that allows for facilitating the consistent and sustainable development of business