QA Auditing

Quality Assurance and Auditing Overview.

Connected auditing solutions. Consistent, independent and flexible.

Consistent auditing expertise.

All auditors are at the level you want.

Transparency.

Your auditor pool is always accessible and new auditors are only included after your approval.

Adaptable.

Auditors can work under Arriello’s or your SOPs.

Global Coverage.

Auditors with experience in Europe, US and APAC.

Multiple Capabilities.

We can connect Vendor, SDEA/PVA and CAPA Plan Management as required.

Independency.

Independent auditing means just that, our auditing services operate as a stand-alone unit in their own right, separate from our related business services.

An extended auditing service.

More than just an audit…

  • Audit Scoping.
  • Audit Planning – including feasibility assessments for remote auditing.
  • Audit conduct – working towards your needs and your procedures, or following Arriello templates as required.
  • Quality control checking audit reports.
  • Suggested CAPAs on request.
  • Review of CAPAs on request.
  • Management of CAPA’s on request.
  • Audit CAPA Closure on request.

An essential part of Quality Management.

In this video, Helen Lowe, Director of Auditing and Quality Assurance, introduces Arriello’s QA services and talks about how we can flexibly support all your GVP auditing and QA needs.

A key advantage with Arriello’s quality management and auditing services versus our competitors, is the consistency and high calibre of our auditing and QA professionals that form a more reliable portfolio of QA professionals. Another is the breadth of outsourcing solutions we can offer that span all QA activities allowing us the scope to fully manage your requirements across your audit universe.

Helen Lowe video
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Beyond auditing… Capability and depth.

Full Quality Assurance Service.

Full Quality Assurance (QA) includes the management of your audit program, including vendors, affiliates and other partner audits, audit CAPA management, vendor management and PVA management.

QA at Arriello also includes a detailed risk assessment and prioritizes a strategic approach to your auditing documentation.

SDEA/PVA Management.

Our team also has the capabilities to manage and update the specific contractual PV relations established with your vendors and partners.

This Global perspective on these processes differentiates us from our competitors as we aim to provide a full scope PV QA service that guarantees additional compliance and reliability.

Alongside SDEA/PVA management, Arriello can also monitor your vendors risks, full information on this service is available upon request.

CAPA management service.

We can use your QMS remotely through a shared platform, or propose the use of our own QMS full-service package.

Services include:

  • Review of the compliance of proposed CAPA’s.
  • Management of the CAPA response document post audit.
  • Entry of the CAPA’s with your own or Arriello’s QMS.
  • Monthly reports and chases of outstanding CAPA’s.
  • Review of any proposed justification for extension.
  • Deviation requests if CAPA’s become overdue.

Remote and Desktop Auditing.

Remote auditing has become the norm during the COVID-19 pandemic and Arriello has embraced this shift, gaining extensive experience with this process. Let us support your organization with this approach and guide you as to when this can be used best.

Desktop audits are not to be confused with remote auditing and they also have a valuable place within the world of auditing.

Arriello also has extensive experience in desk-top auditing and can best advise you how this valuable process can be used within your audit program.

Internal auditing leaders.

Key members from our extensive auditing team.

Helen Lowe Official

Helen Lowe
Auditing and Quality Assurance Director

Helen has over 16 years of experience within Pharmaceutical Research & Development, Quality Assurance (QA), PV and Clinical Site Auditing, Quality Management Systems (QMS), clinical drug development, post marketing drug safety and Regulatory Compliance.

Helen has proven track record of participating in and managing numerous health authority inspections (including FDA, BfArM, MHRA, AEMPS), experience in undertaking mock inspections, providing inspection readiness training/support and performing gap analysis assessments.

During her career as an auditor Helen has conducted over 40 PV audits, managed over 50 and performed/co-audited over 20 GCP audits.

She has in‐depth QA, PV and Regulatory knowledge and experience with: Local Operating Companies/Affiliates, Co‐Development, marketing, license partners, distributors, regulatory due diligence and licensing activities, PV and GCP systems, including Good Clinical Practice (GCP) clinical investigator site auditing, and computer system validations.

Kieran O'Donnell

Kieran O’Donnell
Vice President, Global Drug Safety

Kieran has over 20 years of experience within Pharmacovigilance, with over 16 years of PV QA experience developing PV systems and their quality components including right first time principles, semi-quantitative risk approaches to system reviews and audit planning, through to audit management and conduct.

Kieran certified as an ISO900-2001 Lead Auditor in 2005 and has been an active member of the RQA PV Committee for over a decade, with a proven track record of participating in and hosting numerous health authority inspections (including FDA & MHRA).

He also has experience in undertaking mock inspections, providing inspection readiness training/support, and performing -gap analysis assessments.

During his career as an auditor, Kieran has conducted over 50 PV audits with audit scopes including MAHs, Sponsors, Vendors, Affiliates, Distributors, PSPs, and MRPs, and CSV.

Kieran has lead industry PVQA-benchmarking projects and acquired robust PV, PVQA and QA knowledge and experience.

Claudia official

Cláudia Serafim
PV Manager & QPPV

ISO 9001:2015 trained auditor and a known Pharmacovigilance expert, Cláudia is a pharmacist by education, graduating from the University of Lisbon in 2015.

Cláudia has been acting as QPPV/Deputy for multiple companies since 2018, having also experience with the set-up of Pharmacovigilance systems, PSMF elaboration, and safety communications, including management of MAH consortiums.

Besides the strictly technical experience, Cláudia has also excellent knowledge of related QMS topics, such as procedural documentation, deviation and CAPA management, training requirements and pharmacovigilance auditing, and vendor management requirements.

Complementary, Cláudia has also experience in elaboration in other medical writing documentation, such as Clinical Overviews, Medical Information processing, and is also experienced in Post-Market Vigilance of Medical Devices.

Fully XEVMPD trained, she has extensive knowledge around Medical Device Regulation.

Kami Erbanova Official

Kamila Erbanova
Audit & Quality Assurance Manager

Kamila is an ISO 9001:2015 BSI certified Lead Auditor. An enthusiastic GVP QA professional, she has an in-depth knowledge of GVP requirements and legislation, and extensive experience in implementing and managing PV Quality Management System processes, including PV QA auditing.

She has experience with Local PV Service Providers audits across the globe, as well as with full PV System audits.

Kamila has a proven history of participating in and managing regular PV audits from clients, as well as health authority inspections (including HALMED, Swissmedic, FAMHP, SÚKL), leading root cause analysis investigations and preparing CAPA plans. 

She has also developed and implemented Arriello’s audit and inspection readiness programme.

Kamila also has experience with other practical background activities such as vendor qualification and management, PSMF maintenance, validation activities, and is responsible for the CAPA process within Arriello. 

She has an extensive training record in pharmacovigilance processes and legislation and auditing ISO certification.

External auditing team.

An experienced auditor pool.

  • Our external auditors have on average 15 years experience in GVP and a number are members of RQA.
  • Trained auditors within large MAH settings to global standards, a number trained by ex-regulatory inspectors.
  • All our auditors come from PV operational backgrounds and bring with them an in-depth knowledge base.
  • Each auditor has access to the other pool of auditors as needed and actively share experiences and knowledge in our constant pursuit for improvement.
  • Arriello’s internal auditors ensure continuity and compliment our external team, giving you the flexibility and choice to match your requirements.

Global Coverage: Auditing for different pharmacovigilance legislation around the world.

Our team is fully updated on worldwide legislative requirements and change through our extensive internal regulatory intelligence process. 

Our external pool of auditors also share their experience from audits and inspection, to create a truly united global approach.

Where our auditors are located?

Americas
Canada
United States
Argentina
Europe & Middle East
UK
UK (Scotland)
Ireland
Isle of Man
Netherlands
France
Spain
Portugal
Italy
Germany
Finland
Lebanon
Czech Republic
Russia
Asia & Pacific
Japan
India
Singapore
Australia
New Zealand
Americas

Canada
United States
Argentina

Europe & Middle East

UK
UK (Scotland)
Ireland
Isle of Man
Netherlands
France
Spain
Portugal
Italy
Germany
Finland
Lebanon
Czech Republic
Russia

Asia & Pacific

Japan
India
Singapore
Australia
New Zealand

We can also offer GVP one-off audits and are happy to be added to your preferred vendor lists so we can support GVP audits to organizations when workload does not allow. We are here to support your needs and work with you to achieve your goals. 

You can access our procedures and templates, or Arriello’s auditors can follow your procedures and templates and act as an extension of your team to support your organization whilst recruiting, training or during peaks in workload.

Whether it is an internal audit, a vendor/partner audit, a service provider audit or whether you wish us to conduct a clinical site audit, we’re here to support all your GVP Auditing needs.

Download our Quality Assurance and Auditing brochure…