Operational
Excellence
Continuous
Improvement
Issue
Resolution
Regulatory
and Risk
Management
Effective and efficient
Performance
enhancement via:
Metrics
Audits and inspections
Consultation
Prevent recurrence
through investigation,
correcting and learning
Incidents, deviations
and complaints
Action management
Identifying and managing
business risks and regulatory
requirements
Program and change
management
systems and processes
supported by:
Policies and procedures
Document control
Training
Integrated
Management
of QHS
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QHS integrated management system
Quality
We strive to be a company that clients are
always proud to partner with, so quality
isfundamental to everything we do.
We are committed to delivering services of the highest quality and
tocomplying with all relevant legislation and codes of practice.This
commitment is supported by our management systems, processes
and standards.
A common standard
In 2023, we developed an integrated
management system, which
incorporates both quality and
healthand safety (QHS). The
systemincorporates regulatory and
riskcontrols, consistent and reliable
processes, performance reviews,
andcontinuous improvement,
allofwhich are fundamental to
ourstrong quality culture.
The standard is derived from the
relevant ISO standards (ISO 9001
Qualitymanagement systems and
ISO45001 Occupational health and
safety management systems), and
refers to ISO’s The Integrated Use of
Management System Standards. Our
businesses began to implement the
standard in 2023 and this will continue
into 2024. The standard will ensure that
all Inizio businesses are audited and
assessed against a common framework.
Meeting legal and
regulatoryobligations
Several of our business activities are
subject to regulations, either directly
or through our client relationships.
Many of our pharma and biopharma
clients are governed by the US Food
and Drug Administration (FDA), the
European Medicines Agency (EMA),
and other national and global bodies.
We also adhere to other relevant
regulatory and professional
requirements, such as those that
apply to medicinal product adverse
event and pharmacovigilance
reporting, promotional activities,
patient support services, and other
areas of healthcare compliance.
Inizio is committed to meeting all
legal and regulatory obligations
relevant to our business as we
serveour clients and we recognize
thedetrimental effects associated
with non-compliance.
Continuous improvement
Many of our teams are subject to
regular external quality audits, such
asthose conducted by regulators,
clients, professional associations,
andother certification bodies.
We also perform internal audits of
ourbusinesses to assess and confirm
the effectiveness of our quality
management systems, processes,
and controls.
All regulatory and client quality audits
were successful during the past year,
continuing a long history of strong
performance. Inizio Engage businesses
are subject to regulatory audits, and
during 2023, no critical findings were
received and fewer major observations
were received than in the previous
year. In addition, client audits of
pharmacovigilance processes within
Inizio businesses yielded no major
observations in 2023.
External and internal audit findings
are reflected in our quality
improvement plans.
Quality improvements
in 2023 included:
• Developing and optimizing our QHS
management system, including
ourpolicies and procedures for
process consistency.
• Continuing our global implementation
of a validated document and
workflow management system.
• Introducing a new request
handlingsystem, implemented
byour Inizio Engage Quality (QHS)
and Compliance team.
• Establishing a new Operational
Excellence team in one of our
business lines.
• Optimising a vendor performance
review process.
• Developing training courses for
delivery via the new learning
management system, Vita.
Inizio Sustainability Report 202338