38 Inizio Sustainability Report 2023 Quality We strive to be a company that clients are A common standard The standard is derived from therelevant ISO standards (ISO 9001Inizio is committed to meeting allQuality improvements always proud to partner with, so quality In 2023, we developed an integrated legal and regulatory obligations in 2023 included: management system, which Quality management systems and relevant to our business as we is fundamental to everything we do. incorporates both quality and ISO 45001 Occupational health andsafety management systems), andserve our clients and we recognize •Developing and optimizing our QHS health and safety (QHS). The the detrimental effects associated management system, including We are committed to delivering services of the highest quality and system incorporates regulatory and refers to ISO’s The Integrated Use of with non-compliance. our policies and procedures for to complying with all relevant legislation and codes of practice. This risk controls, consistent and reliable Management System Standar . Ourds process consistency. commitment is supported by our management systems, processes processes, performance reviews, businesses began to implement the Continuous improvement and standards. and continuous improvement, standard in 2023 and this will continue Many of our teams are subject to •Continuing our global implementation all of which are fundamental to into 2024. The standard will ensure that regular external quality audits, such of a validated document and our strong quality culture. all Inizio businesses are audited and as those conducted by regulators, workflow management system. assessed against a common framework. clients, professional associations, Introducing a new request • and other certification bodies. handling system, implemented QHS integrated management system Meeting legal and by our Inizio Engage Quality (QHS) regulatoryobligations We also perform internal audits of and Compliance team. Several of our business activities are our businesses to assess and confirm Identifying and managing Effective and efficient subject to regulations, either directly the effectiveness of our quality •Establishing a new Operational business risks and regulatory systems and processes management systems, processes, Excellence team in one of our requirements supported by: or through our client relationships. Many of our pharma and biopharma and controls. business lines. Program and change Regulatory Operational Policiesand procedures management and Risk Excellence clients are governed by the US Food •Optimising a vendor performance Management Document control and Drug Administration (FDA), the All regulatory and client quality audits review process. European Medicines Agency (EMA), were successful during the past year, Training continuing a long history of strong Developing training courses for and other national and global bodies. • Integrated We also adhere to other relevant performance. Inizio Engage businesses delivery via thenew learning Management are subject to regulatory audits, and management system, Vita. of QHS regulatory and professional requirements, such as those that during 2023, no critical findings were Prevent recurrence Performance apply to medicinal product adverse received and fewer major observations through investigation, enhancement via: were received than in the previous correcting and learning Issue Continuous event and pharmacovigilance Resolution Improvement Metrics reporting, promotional activities, year. In addition, client audits of Incidents, deviations pharmacovigilance processes within and complaints Audits and inspections patient support services, and other esses yielded no major areas of healthcare compliance. Inizio busin Action management Consultation observations in 2023. External and internal audit findings are reflected in our quality improvement plans. P R E V E N T I V E C O R R E C T I V E D E T E C T I V E