AX FOR PHARMA QUALITY POLICY

A) Management Statement

The Management believes that to achieve a strong and sustainable development, it is critical to pursue systematically 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.

The products and services consist of the identification and development of high Quality world standard software (GAMP 5 Category 4) able to add value to software products of third-party companies realizing specific vertical features. The primary targets are the business units that operate in the process industries with focus on the pharmaceutical, chemical and life-science 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, direct Company sales to the end Customers for products and services of AX for Pharma Group (e.g. Enterprises).

To achieve the above objectives and to ensure the continuous improvement of the highest standards the Company believes that the continuous development of a culture of Quality is essential to reflect the Companys values and to provide the basis of a superior of 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 even more complete with the compliance to GMP for Customers of the Pharmaceutical, Chemical and Life Sciences sectors, and with the adoption of the Microsoft Methodologies.

The Company has encountered and solved many of the opportunities and issues that surfaced over the last years of activity and have led towards the implementation of a complete and advanced Quality Management System with enhanced operational tools and required systematic dedicated training.

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

  1. Determined external and internal issues that are relevant to its strategic direction and that may affect the ability to achieve the results of its Quality Management System (QMS);
  2. Established a systematic approach to consider risk, as the parameter to guide the Companys decisions and activities. The previous method was based on prevention.

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

The Management is systematically promoting all necessary actions to ensure that all activities and processes are developed with the highest Quality Standards in a cost-effective and efficient way. The main tool consists in activating a Business Management System marked by the following fundamental principles and the relevant procedures:

  1. Superior value of products and services;
  2. Continuous improvement of the products and services;
  3. Individual and collective passion for innovation of all the activities;
  4. Full involvement of the Staff and high level of knowledge in the Quality processes;
  5. Tools for obtaining the highest qualification available by the Staff to deliver a delivery of excellence;
  6. Compliance with contractual requirements;
  7. Proactive commitment to prevent problems and insufficient performance;
  8. Efficiency and effectiveness of internal resources through organizational integration and interpersonal interaction aiming to work as a team and to analyze the experiences as the basis for the continuous improvement.

The Quality Management System is described in the Quality Manual. The Quality Manual lists the procedures and the instructions that define the ways in which activities must be carried out as established by the Company Management in order to provide products and/or services in line with the requirements of the Customers for performance and for compliance with the legislation and the regulations. The entire system is submitted to testing both internally and externally by a Certified Body at least once a year. The results of the internal audit are discussed in the Management Review which also monitors the objectives outlined in the Improvement Plan as well as 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.

B) Basic Principles

Customer Satisfaction means giving technically superior products and services with a perceived Quality at the highest standards in the industry.

  1. The Quality of our products and services is the result of continuous improvement of our knowledge, professionalism, individual and group methods. It is not possible to supply Quality products and services if the work is not made at the highest possible Quality during all stages of a Project.
  2. The Quality of our products and services depend on our ability to anticipate the future. Being proactive is necessary to implement and continuously improve our ability to anticipate, avoid and/or resolve the possible causes of non-compliance (deviation) in order to prevent their recurrence.
  3. The perception of Quality is created by our products and services at the time of delivering solutions in conformity to the expectations of our Customers.
  4. Given the highly technical nature of the products and services offered, any contract or commitment must be clearly formulated and must be easy to understand by the Customer. The products and services must be coherent with the requirements of the Customer.
  5. The process of service delivery (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 depend 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 a key moment in confirming the Quality of our products and/or services.

The Quality Policy is updated periodically to maintain the Company at the highest Quality standards versus the market, the technology and regulations changes.