Quality Management System (QMS)

The risk-based QMS is based on the process management
model and integrates identified main and auxiliary
processes along with management processes that are
common for the system.
Santens QA philosophy is based on the above listed
international guidelines and tackles quality of customer
servicing in the course of storing and handling their
products within Santens logistics hubs along with
transporting such products from the point of view of the
product life cycle.
The QMS fully comprises statutory requirements (by the
government) that are mandatory for Santens activities
along with consumers and partners' requirements that do
not contradict to the mandatory statutory requirements.
Santens has identified QMS stakeholders along with their
requirements, needs and expectations and now regularly
review the stakeholders, monitor their satisfaction and
trends in their needs and expectations.

We focus on four major elements of the management system:

• Monitoring of processes and service quality
• CAPA management
• Change management
• Reviewing QMS performance and efficiency by the management team.

• The processes are monitored according to a set of performance indicators that meet SMART rules.
• Santens change management system makes it possible to assess, approve and put in place major changes in line with risk assessment with regard to the quality of pharmaceuticals and services. Thus, we ensure timely and efficient continual improvement alongside with a high degree of assurance that any changes do not entail unintended consequences.
• The CAPA management system purpose is to rectify causes of identified and proposed non-conformities.

We develop CAPA plans as a result of:

1. Investigating deviations
2. In-house audits
3. Third party audits
4. Audits by controllers
5. KPI reviews and assessments
6. Investigating causes of customers' claims
7. Customer satisfaction assessment

Our efforts, formalizing and documenting investigations
are comparable to the risks for the quality of
pharmaceuticals and services.

• Our continual improvement of the processes and service quality is based on monitoring internal and external influences as a part of regular management team's reviews.

The range of services provided by Santens Group has expanded and significantly changed over the recent 4 years due to the Track&Trace project that was implemented for pharmaceuticals in the RF. The QMS development
improvement trend for the recent 4 years is:

• A new QMS requirement covering Data Integrity
• Along with compliance with ISPE GAMP Good Practice Guide – IT Infrastructure Control and Compliance, and provision of internet security as prescribed by Santens customers.

Santens keeps on deploying new tools to automate in-house managerial and supporting processes, and offer novel IT tools and solutions to the partners to enforce compliance with mandatory government requirements with regard to
tracking details of pharmaceuticals across the supply chain in the RF.

We have in place WTS and PharmConnector IT solutions to keep records about serialized pharmaceuticals delivered to and shipped from Santens logistics hubs and also keeps records about all pharmaceutical relevant transactions while warehousing, and then transmit the data about serialized pharmaceuticals to the customer's system for further transmitting to the medical product tracking system (Pharmaceutical Movement Monitoring System) via a special integrated solution for data exchange between Santens in-house systems and the customer's ERP system.

To track IT faults, we use GLPI application.
The WebTutor tool was implemented for in-house training processes in the distant learning mode in accordance with training programmes and modules, for personnel testing, and Santens knowledge data base structuring and
maintaining.
Jira pilot project has been implemented in Santens for the recent 3 years in line with Data Integrity and Pharm requirements.
JIRA manages QMS processes and makes it possible to build management processes such as management of nonconformities (deviations, in-house and third party audits), follow up tasks (CAPA addressing non-conformities), and also generate reports and assess performance.
All the computer-aided systems used by Santens are validation objects and have been assessed by the Quality Directorate in terms of their criticality (GMP). We are implementing a number of validation projects initiated by the Quality Directorate. The computer-aided system validation scope is defined for each CAS in view of its criticality, GAMP5 category, life cycle concept, data integrity
and fault or failure probability.

Santens sustainability and success is based on its ability to be adaptable to changes and open to innovations based on knowledge and risk management.
We believe that quality knowledge management and risk management are primary tools for improving our integrated quality system.

Knowledge management system

We are identified the knowledge required for business process functioning and product and service compliance. Our knowledge collecting, reviewing, accumulating and disseminating processes have been systematized at the
corporate level.

Santens knowledge base is as follows:

• QMS documents
• Third party audit reports
• In-house study materials
• Third party instructors' study materials
• Various corporate marketing studies
• Lessons learned after previous tasks
• Key employees' experience shared through mentoring

The Quality Directorate has a Training Centre that builds
and manages regular in-house trainings for QMS relevant
personnel. There are approved training programmes on
corporate regulations. There is a GDP mandatory training
that is arranged every year.
The WebTutor tool facilitates study paperwork
dissemination and post-training tests.

Our systemic approach to the knowledge management:

• Allows our professionals to apply gained knowledgeand skills to everyday tasks and routine duties,
• Contributes to the staff development along with acquisition and accumulation of new practical and theoretical knowledge covering storing, handling and transporting pharmaceuticals,
• Serves as an underlying reason for further personnel professional growth within the company

We review risks and opportunities we are exposed to and that may arise due to in-house and external influences or as a result of applicable requirements that may be identified by our subject matter expert team in charge of identifying,
assessing and reviewing risks and of following up risk mitigation action plan.
Thus, our decision-making is based on the accumulated quality knowledge and risk assessment for both products being handled and services being provided.
Santens senior management is a core task force for the activities and a coordinator of the risk management process between various lines of business activities and various business units; they enable defining, putting in place and
auditing the risk management process along with allocating resources to manage risks.
Santens senior management team attitude contributes to the ongoing sustainable development of our QMS that