1.1 Management Statement


The Management believes that to achieve solid and sustainable development, it is critical to systematically pursue the highest standards of excellence and
quality in the products and services offered. This is the only way to create the maximum perceived value and, therefore, the highest possible customer satisfaction. This belief is also supported by the STAEDEAN Management Team, which is committed to establishing a Quality & Compliance department for the Group.  

A strong quality commitment can ultimately lead to enhanced customer loyalty, a positive brand reputation, and continued success in the marketplace. 

The STAEDEAN Life Sciences products and services consist of identifying and developing high-quality world standard software (GAMP 5 Category 4) that can add value to third-party companies' software products, realizing specific vertical features. The primary targets are the business units that operate in the process industries, focusing on the pharmaceutical, chemical, and life sciences sectors. The channel used to reach these businesses will consist of a global network of expert resellers and partners active in those sectors and, where applicable, the group sales directly to the end customers (e.g., enterprises). 

To achieve the above objectives and ensure continuous improvement of the highest standards, the Group believes that the continuous development of a culture of quality is essential to reflect the Group's values and provide the foundation for a superior Quality Management System. As part of the continuous improvement of this system, it was also decided to submit it for ISO 9001:2015 certification to make it rigorously compliant with GMP for customers in the pharmaceutical, chemical, and life sciences sectors, through the adoption of Microsoft methodologies  

The Group has encountered and addressed many of the opportunities and issues that surfaced over the past few, years of activity, which has led to the implementation of a complete and advanced Quality Management System with enhanced operational tools and the required systematic, dedicated training. 

Due to the new ISO 9001:2015, the organization has: 

1.   Determined external and internal issues relevant to its strategic direction that may affect its ability to achieve the results of its Quality Management System (QMS). These are indicated in the Context of Organization (COR) document. The COR is periodically updated, highlighting the modification from the previous version in red.  

2.  Established a systematic approach to consider "risk" as the parameter to guide the Group's decisions and activities. These are indicated in the Risk-Based Evaluation (RBE) matrix. The RBE is periodically updated, highlighting the modification from the previous version in red. 

Our strategic objective is to provide customers with products, management services, and information technology at the highest level and maximize the perceived value, thus achieving the highest level of customer satisfaction possible. These objectives are reflected at the operational level in a series of activities ranging from recruitment techniques to selecting products and services and the staff operating procedures in all departments in compliance with the contractual requirements. 

The Management systematically promotes all necessary actions to ensure that all activities and processes are developed efficiently, cost-effectively, and with the highest quality standards. The primary tool consists of activating a Business Management System marked by the following fundamental principles and relevant procedures: 

  • Superior value of products and services. 
  • Continuous improvement of the products and services.
  • Individual and collective passion for innovation in all activities.
  • Full involvement of the team and high level of knowledge in the quality processes.
  • Tools for obtaining the highest qualification available by the team to ensure a delivery of excellence.
  • Compliance with contractual requirements.
  • Proactive commitment to preventing problems and insufficient performance.
  • Efficiency and effectiveness of internal resources, achieved through organizational integration and interpersonal interaction, aim to work as a team and analyze the experiences as the basis for continuous improvement. 


The Quality Management System is described in the quality manual. The quality manual lists the procedures and instructions that define how activities must be carried out as established by the Management to provide products and/or services in line with the customers’ requirements for performance and compliance with the legislation and the regulations. The entire system is submitted to internal and external testing by a certified body at least once a year. The internal audit results are discussed in the management review, which also monitors the objectives outlined in the improvement plan and the assessment of the continuing suitability of this policy. The results of the external audits are reported in the audit report issued by the certified body. 

1.2 Basic Principles

Customer  satisfaction means giving technically superior products and services with a perceived  quality of the highest standards in the industry. 

The STAEDEAN basic principles are:  

1.  The quality of our products and services results from continuous improvement of our knowledge, professionalism, and individual and group methods. It is impossible to supply  quality products and services if the work is not done at the highest possible  quality during all stages of a  project. 

2. The quality of our products and services depends on our ability to anticipate the future. To prevent their recurrence, being proactive is necessary to implement and continuously improve our ability to anticipate, avoid, and/or resolve the possible causes of non-compliance (deviation). 

3. Our products and services create the perception of  quality when delivering solutions in conformity with our customers' expectations.  

4. Given the highly technical nature of the products and services offered, any contract or commitment must be clearly formulated and easy for the customer to understand. The products and services must be coherent with the requirements of the customer. 

5. The service delivery process (analysis, planning, implementation, delivery, and support post-delivery) must be strictly controlled and carried out both technically and economically to ensure its conformity with the contract. 

6.  The quality of our products and services crucially depends on the quality provided by our suppliers. The selection and management of these partners must be handled with fairness and rigorous methodology (e.g., contracts, operating specifications, etc.). 

7.  Customer service and any general activity carried out for the customer after delivery of the products and/or services is critical in confirming the quality of our products and/or services.  

The quality policy is updated periodically to maintain the Group at the highest quality standards versus the market, technology and regulations changes. 

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