Quality Policy and Objectives

Purpose

Agilis’ Quality Policy documents the strategic commitment of the company, at the highest management level, to implement all the technical and organisational measures and actions necessary to ensure that the company provides in a consistent way services that fulfil or exceed the needs and expectations of customers and all other interested parties, meet all applicable statutory and regulatory requirements, as well as anticipate future needs.

Quality Policy Directives

Furthermore, to achieve this aim the company is committed to the establishment, operation and continual improvement of a Quality Management System including all appropriate processes and controls and to ensure all the resources necessary for the effective operation and continual improvement of this management system.

This Quality Policy is made publicly accessible and is meant to be communicated urbi and orbi, to the company’s personnel and to all interested parties, including customers, partners and users of the company’s software services, and any other stakeholder. The policy should be used as an instrument to raise awareness and cultivate a quality oriented company culture and customer focus.

This policy and its quality objectives are meant to be regularly reviewed, assessed for their effectiveness, and revised within the framework of the company’s management review process, to reflect changes in the business environment and the company’s strategic directions, as well as new and emergent risks and opportunities.

The Quality policy is authorised by the company’s Managing Director and endorsed by the Board of Directors as an indication of commitment of the company at the top management level.

Quality Policy Principles

Top Management Responsibility and Accountability

While authorities and responsibilities for the implementation and operation of the company’s Quality Management System are delegated to competent persons, the company’s top management takes full responsibility for the implementation of the Quality Policy and is ultimately accountable for customer and stakeholders satisfaction and for the effectiveness of the Quality Management System.

For this reason the company’s top management is committed to the allocation of all the resources required for the effective design, operation and continuous improvement of the ISMS, including planning and budgeting for human resources, infrastructure, knowledge and competence acquisition, methods and tools, as well as for high-level specialised external support and expert consultancy where needed. Top management evaluates the adequacy of these resources and plans for their availability during the overall Management Review process of the company.

Steering through Quality Objectives

This policy sets a framework of quality objectives, directly relevant to the company’s mission, strategy, business environment and the needs and expectations of interested parties, after an assessment of risks and opportunities created by the business environment and internal factors.

These strategic-level objectives are meant to be subsequently translated to specific technical and organisational objectives at the tactical level, which should be planned for, monitored and assessed and if necessary adapted and revised.

Policy Implementation

Moreover, top management ensures that the Quality Management System achieves its intended results by monitoring its effectiveness and planning and assigning actions required to correct or improve the systems and its processes.

The implementation of this Quality Policy in terms of the aforementioned specific objectives, as well as the status and the effectiveness of the QMS, are regularly monitored and assessed based on management review inputs, key performance indicators and regular internal audits.

Continual Improvement

The continual improvement of the quality management system is endorsed by top management as one of the main pillars of its success. Information and recommendations from audits, evaluations and management reviews are communicated while initiatives for improvement are encouraged at all levels and for all personnel.

All personnel, and especially staff at management roles at all levels, is actively encouraged to contribute to the effectiveness of the QMS in their respective domains, and motivated to undertake initiatives for the continual improvement of the quality of services and of the processes applied to ensure their quality.Top management is always acting as champion of projects for improvements.

Management is committed to directly provide mentoring, support and guidance to all persons either directly in charge of the quality management system implementation or indirectly involved in any activity affecting quality, to provide strategic direction and priorities, and to closely cooperate with them to ensure conformance to requirements and improvement.

Customer Requirements and Customer Feedback

The continuous identification and analysis of requirements, needs and expectations of customers and other interested parties, including statutory and regulatory requirements, is another fundamental pillar of the quality policy. Requirements elicitation is done systematically in aspects of cooperation with customers and third parties, but also exploiting available sources and investigating industry trends and scientific / technological research directions.

Customer feedback and assessment of customer satisfaction are integrated in the contract management process and constitute a primary indicator of the effectiveness of the QMS.

Risk based planning

The achievement of quality objectives, implementation of changes and improvements, management of risks et.c. are systematically planned and monitored.

A systematic risk assessment approach is applied at various levels, from the planning of quality requirements and objectives, to project management, to auditing of the processes of the quality management system, to identify and assess quality related risks as they emerge, decide on their proactive treatment and determine actions necessary for their prevention.

Effective integration into the the company’s overall business processes

The quality management system is conceived and designed to be the backbone of all the company’s business processes and operations and not a mere “add-on” of documentation and control to ensure that quality is integrated in the entire life cycle of services, from requirements analysis and design, to delivery and release.

The quality management system is designed to ensure the consistency and improvement of the practices followed and whenever possible the QMS procedures have been seamlessly encapsulated into the systems and tools used for the actual management activities and delivery of services.

The quality management system is also used to promote a systematic process oriented management mindset by emphasising the underlying structure and dynamics of everyday operations in terms of interacting processes and flows.

Control and measurement

Conformity and compliance controls have been integrated in the life cycle of product and service design, production and release, using whenever possible automated tools, and applied to software validation and testing, including code reviews, controlled testing and code quality measurement, internal documented reviews of reports and deliverables, and validation of datasets. The results of controls are used for quality measurement and monitoring.

All quality related events, including identified non-conformances, customer feedback and complaints, planning performance et.c. are recorded in the company’s Task Management System and used for the production of quality indicators and monitoring.

Authority and responsibility

The company has endorsed with all the necessary personal authority and responsibility a suitably qualified Quality and Compliance (QA/C) Manager in charge of closely overseeing and managing the implementation of this policy. The QA/C Manager reports directly to the Managing Director.

Awareness

Agilis commits the necessary resources for planning and executing activities for in-house awareness raising and training in quality matters in order to communicate the importance of quality to all the company’s personnel and ensure that customer focus is an integral aspect of the company’s culture.

Quality requirements are communicated and discussed in dedicated town-hall meetings and company-wide information sessions.

Competence and training

Apart from general awareness, it is ensured, in a documented way, that personnel involved in the application of QMS procedures, are adequately trained and have all the necessary competence and knowledge to effectively apply the procedures and ensure meeting quality requirements.

Right to audit

Customers or any other party with legitimate interest have the right to request specific detailed information, as well as inspect or audit the company’s quality management system.

Strategic Quality Objectives

This policy sets a framework of strategic objectives related to information security, as emerging from the analysis of the business environment, the needs of customers, users, and stakeholders and the applicable regulatory requirements.

The strategic quality objectives of the company are to ensure the following quality dimensions:

1. Technical quality in all product and service inherent quality characteristics and in all in all service life-cycle stages, of software development and Software as a Service offering, Statistical Analysis services and Clinical Data Management Services including engineering and methodological soundness, fitness for use, effectiveness and relevance, robustness and reliability, integrity and consistency/coherence, as well as conformance to international and industry standards for software and for statistical reporting.

2. Reliability and predictability of service delivery, i.e. delivery according to predefined specifications, agreed methods and demonstrably robust and controlled processes, including for outsourced processes either specifically defined in contractual obligations or according to industry standards and best practices.

3. Project management quality, i.e. planning flexibility and timeliness in the deployment of clinical databases and delivery of statistical analysis services and clinical data management services, understanding of requirements, planning and timeliness, effective communications and documentation.

4. Regulatory compliance concerning software functionality and software validation, clinical database documentation and management and clinical data management processes and documentation.

5. Enrichment of services with value added for customers, e.g. ensuring constant, close and efficient collaboration and support to achieve their aims, including technical and scientific expertise and consultancy, coverage of new and emerging needs, taking advantage of technological advances, new clinical study models, and emerging industry trends.

6. Company quality, i.e the level of overall customer and partner confidence and the perception of all interested parties as regards the technical excellence, reliability, professionalism and sense of responsibility of the company as a whole and of persons in charge of service delivery.

QMS-020-Q v.2