Quality Management System (QMS)

The company's Quality Management System has been developed based on a process management model and includes identified primary and auxiliary processes, as well as system management processes as a whole, and is based on a risk-oriented approach.

The concept of quality assurance in the Santens Group of Companies, based on the above-mentioned international requirements, defines the approach to quality assurance in the provision of services to clients of the Santens Group of Companies in relation to storage, warehouse handling of clients' products placed in the warehouses of the Santens Group of Companies, as well as to transportation of products, from the standpoint of the product life cycle.

The company's Quality Management System fully takes into account the legislative requirements (state regulations) that are mandatory for the implementation of the activities of the Santens Group of Companies, as well as the consumers and partners’ requirements that do not contradict the mandatory legislative requirements.

The ‘Santens’ Group of Companies has identified stakeholders related to the Quality Management System, as well as these stakeholders’ requirements, needs and expectations and regularly evaluates these parties, as well as monitors satisfaction, identifying trends in the stakeholders’ changing needs and expectations.

We focus on four important elements of the management system:

A system for monitoring processes and service quality;
CAPA management system;
Changes management system;
Analysis of the QMS effectiveness and efficiency performed by the company management.

A system for monitoring processes and service quality;
CAPA management system;
Changes management system;
Analysis of the QMS effectiveness and efficiency performed by the company management.
Process monitoring is carried out according to a set of performance indicators that comply with the SMART rules system.
The system implemented in the Santens Group of Companies — Change management — allows for the necessary assessment, approval and implementation of significant changes based on risks assessment for the quality of medicines and of services. Such a system ensures the timeliness and effectiveness of continuous improvement, and at the same time, provides a high degree of confidence, in the absence of unplanned consequences of any changes being implemented.
The CAPA management system is aimed at eliminating the causes of identified and suspected non-conformities.
CAPA plans are developed based on the results of:

deviation investigations;
internal audits;
external audits;
regulatory inspections;
KPI analysis and assessment;
customer complaints’ investigation;
customer satisfaction assessment.
The level of effort, formalization and documentation of investigations is proportionate to the level of risks for the quality of medicines and of services provided.

Continuous improvement of processes and service quality is achieved through monitoring of internal and external factors affecting the system, within the framework of periodic management reviews.

The range of services provided by the Santens Group of Companies over the past 6 years has expanded and changed significantly due to the gradual implementation in the Russian Federation of a TRACEABILITY SYSTEM for  pharmaceutical products for medical use, pharmaceutical products for veterinary use, dietary supplements, certain types of medicinal products, and certain types of cosmetic products.

The development and improvement trend of the Santens Group of Companies’ QMS over the past 6 years:
implementation of the requirements for ensuring the Data Integrity in the QMS, as well as the applicable requirements of the international ISPE  guide such as ISPE GAMP GPG «IT Infrastructure Control and Compliance» and ISPE GAMP Guide –«Records and Data Integrity», as well as the requirements for ensuring information security dictated by the Santens Group Clients.
Our main goal is to improve the technological effectiveness of the QMS, to ensure Data Integrity of GxP critical Data.
Santens Group has  implemented new and advanced tools  to automate internal management and support processes, and offers its partners new IT tools and IT solutions,  that ensured compliance with the mandatory  state requirements regarding traceability of information on pharmaceuticals and related products from pharmaceutical manufacturers in the Russian supply chain.

The Santens Group of companies has implemented WTS and PharmConnector – IT solutions that allow registering information on serialized  pharmaceutical products  and   related products of Customers that arrived at the warehouses of Santens Group of Companies and shipped from the warehouses of Santens Group of Companies, as well as registering all transactions of pharmaceutical products and related products of Customers when  they are handled in warehouses and transferring the received Data on serialized pharmaceutical products  and related products of Customers to the Customer’s system for further Data transfer to the MDLP information system (Federal State Information System for Monitoring the Movement of Pharmaceutical Products) or   to the GIS MT ( State Information System for Monitoring Goods Movement)  using a special integration solution for Data exchange between Santens internal systems and the Customer’s ERP.
To track IT incidents, Santens Group of Companies has implemented the automated GLPI system.

To automate internal training processes, the automated WebTutor system has been implemented. It   enables us toperform a  remote internal training on training programs and modules,  to carry out personnel testing,  to create  and to maintain the Santens Group of Companies Knowledge Base.

All computerized systems used by Santens Group of Companies have been assessed by the Quality Department in terms of their  GxP criticality (GxP impact) and have been validated. Santens has been implemented several validation projects. Quality Department is the integrator of all qualification and validation projects. The scope of validation tests of the Computerized Systems is determined for each specific computerized system, take into account the system criticality level, the computerized system category in terms of GAMP5, the system life cycle approach, as well as Data Integrity, the risk of system failure or malfunction.
Guarantee of sustainable and successful development
Sustainable and successful development of the Santens Group of Companies is achieved through the ability to take into account changes and implement the necessary innovations based on knowledge and risk assessment.
Santens Group of Companies considers knowledge management and Quality Risk management as the main tools for improving the integrated Quality Management  System of the Santens Group of Companies.

Sustainable and successful development of the Santens Group of Companies is achieved through the ability to take into account changes and implement the necessary innovations based on knowledge and risk assessment.
Santens Group of Companies considers knowledge management and Quality Risk management as the main tools for improving the integrated Quality Management  System of the Santens Group of Companies.

Knowledge Management System

The Santens Group of Companies has defined the knowledge necessary for the functioning of its business processes and for achieving compliance of products and services.

We systematize the process of collecting, analysing, accumulating and disseminating knowledge by the company's personnel.

The Santens Group of Companies’ knowledge includes:
• Quality Management System documents;
• external audit results;
• training materials for internal training;
• training materials provided by external trainers;
• various marketing research of the company;
• developments on previous tasks;
• key employees’ experience transferred through mentorship.
As part of the Quality Directorate, there is a Training Centre that builds and administers a system of regular internal training for all company personnel involved in the QMS, within the framework of approved training programs according to the company's internal regulatory documents, including mandatory annual training on GDP (Rules of Good Distribution Practice).
The automated WebTutor training system implementation allows for using training materials and assessing the training effectiveness.

The use of a systematic approach to knowledge management:
- helps our specialists use the acquired knowledge and skills to solve professional problems at the proper level and in accordance with their assigned responsibilities;
- promotes the development, acquisition and accumulation of new practical and theoretical knowledge by employees, including that related to the specifics of storage, processing and transportation of pharmaceutical products;
- determines the personnel’s further professional growth within the company.

Santens Group analyses the risks and opportunities to that the company is exposed and which may arise due to internal and external factors, as well as applicable requirements, as part of the regular work of the company's expert group on identification, assessment, risk analysis and monitoring of the implementation of the risk mitigation plan.
Thus, all decisions taken are based on the accumulated knowledge and risk assessment for the quality of both the processed products and the services provided.
The Santens Group top management actively participates in this work and is responsible for coordinating risk management between different types of activities and different divisions in the Company; ensures that the quality risk management process is determined, is in operation and is verified, as well as provides sufficient resources for risk management.
Such an active position of the Top Management of the Santens Group of Companies allows us to create a basis for the continuous sustainable QMS development, that meets mandatory external regulatory requirements and Customer’s requirements, and also allows us to provide afoundation for initiatives aimed at sustainable development. Santens Group aligns international experience in achieving their goals, to improve the QMS, which allows us to provide conditions for consistent and sustainable business growth.
Maintenance, development and improvement of QMS is a strategic decision of Santens Group of Companies