TwitterLinkedin

Contact Us

  • News & Events
    • News
    • Webinars
    • Events
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Working at PharmaLex
    • Your Application Process
    • Current Opportunities
  • Training
Top Bar
Search
PharmaLex Logo
MENUMENU
  • PharmaLex Logo
  • PharmaLex Logo
  • About UsAbout Us
    • About Us
    • Management Team
    • Our Milestones
    • Corporate Social Responsibility
    • What Our Clients Say About Us
  • Our Services
    • Discovery / Non-clinical
          • Go to Discovery / Non-clinical section >>

          • Strategy and Consulting

            • Development Strategy and Gap Analysis
            • Integrated Product Development
            • Market Access
            • Non-clinical Development Concept
              and Study Design
            • Scientific Advice
            • Scientific Due Diligence
            • Statistical Services
            • Toxicology Services
    • Clinical Development
          • Go to Clinical Development section >>

          • Strategy and Consulting

            • Clinical Program Development
            • Orphan Drug Designation
            • Pediatric Investigation Plan (PIP)
            • Scientific Advice
            • Statistical Services
          • Regulatory Affairs

            • Clinical Trial Applications
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Regulatory Operations
          • Pharmacovigilance

            • Clinical Trial Safety Support
            • Pharmacovigilance Consulting
          • Quality

            • GxP Services
            • IMP Management
            • Interim / Contract QA
            • Quality Management Systems
            • Tech Transfer / Scale-up
            • Vendor Management and Oversight
    • Authorization / Approval
          • Go to Authorization / Approval section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Regulatory Operations
            • Scientific, Regulatory and Technical Writing
            • Statistical Services
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • Pharmacovigilance Consulting
          • Quality

            • Commercialization Readiness
            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • PAI Readiness
    • Post-approval / Maintenance
          • Go to Post-approval / Maintenance section >>

          • Strategy and Consulting

            • Environmental Risk Assessment
            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Mergers and Acquisitions (M&A) Transfers
            • Regulatory Operations
            • Toxicology Services
          • Pharmacovigilance

            • Audit and CAPA Management
            • EU QPPV / National QPPV
            • ICSR Management
            • Literature Screening
            • Pharmacovigilance Systems
            • Safety Writing (PSUR, RMP)
            • Signal Management
          • Quality

            • Commissioning, Qualification, and Validation (CQV)
            • Good Distribution Practice (GDP) Compliance
            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
            • Vendor Audit
            • Vendor Management and Oversight
          • Medical Affairs

            • Healthcare Compliance and Medical Approval
            • Medical Information
    • Program Management
          • Go to Program Management section >>

          • Program Management

            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Integrated Product Development
            • Mergers and Acquisitions (M&A) Transfers
    • Featured Expertise
          • Industry Expertise

            • Biopharmaceuticals
            • Consulting
            • Consumer Healthcare
            • Generics
            • Herbal Medicines
            • Medicinal Products
            • MedTech Services
            • Pharmaceutical
            • Veterinary Drugs
          • Service Expertise

            • ATMP / Cell and Gene Therapy
            • Brexit
            • COVID-19 Support
            • Drug Re-purposing / Value-added Medicines
            • GxP Services
            • Market Access
            • Pharmacovigilance Consulting
            • Statistical Services
            • SMARTPHLEX - technology-enabled services
  • Global ReachGlobal Reach
  • Contact usContact us
  • News & Events
    • News
    • Webinars
    • Events
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Working at PharmaLex
    • Your Application Process
    • Career Opportunities
  • Training
Home > Our Services > Audit and CAPA Management

Audit and CAPA Management

Leading technological innovation

Marketing Authorization Holders need to fulfil their responsibilities to perform regular risk-based audit(s) of their pharmacovigilance system (i.e. auditing of their affiliates and partners). In addition, vendor qualification audits need to be conducted on demand.

Our Pharmacovigilance audits obtain evidence and evaluate the evidence objectively to determine the extent to which the audit criteria are fulfilled and contribute to corrective and preventative actions (CAPA) ensure the improvement of risk management, control, and governance processes.

We apply our broad and long-term experience, as well as global network to fulfil the requested support regarding the planning Pharmacovigilance audits at various levels (strategic, tactical, and operational).

Want to find out more?

PharmaLex. Confidence beyond compliance.

Contact us for more information

Audit Service Levels

  • Support for defining and implementing risk-based audit strategy / process
  • PV System / Process gap analysis and pre-inspection support
  • Conduct PV audits on behalf of the company:
  • System audits at headquarter level
  • Affiliate audits
  • License partner and distributor audits
  • Vendor and service provider audits
  • Process and document audits (g. Pharmacovigilance System Master File (PSMF), Risk Management Plan (RMP), Periodic Safety Update Report (PSUR), QPPV Oversight)

Audit Services

  • Prepare of audit plans, conduct of the audits and provision of detailed audit reports
  • Provide flexible allocation of auditors based on annual audit program and risk-based audit strategy according to GVP requirements
  • Ensure adherence to the annual audit program
  • Conduct ad-hoc and triggered audits upon request
  • Perform compliance monitoring and reporting to QPPV and QA department regarding timely CAPA implementation and audit results
  • Support for implementation of company procedure(s) on auditing and CAPA management
  • Support for follow-up activities of audits or Health Authorities inspections, i.e. the management of corrective and preventive actions (CAPAs)

PharmaLex offers customized Pharmacovigilance Auditing service based on audit scope and complexity:

PV audit services

Related News

Supporting M&A in the pharmaceutical / biopharmaceutical industry
11th February 2021
Annex 1
EU GMP Annex 1
25th January 2021
SMARTRISK
SMARTRISK - risk assessment excipient tool
12th January 2021

Related Resources

Webinars

  • Excipient Risk Assessment as per the EU Guidance and SMARTRISK as a solution
  • Risk Management of the presence of Nitrosamines in medicines
  • Environmental Risk Assessments for Human Medicinal Products

Infographics

  • Technical Helpdesk
  • Virtual Auditing for GxP Compliance

Video & Animation

  • SMARTRISK - What is SMARTRISK
  • SMARTPHLEX - Technology-enabled Smart Solutions
  • Using Technology-enabled Smart Services - what are the benefits?

Related Services

  • SMARTPHLEX
  • SMARTRISK
  • SMARTVIGICONTRACT
  • SMARTVIGILIT
  • SMARTVIGISCREEN
  • Vendor Audit
  • Virtual Audits

What our clients say

I just wanted to let you know that the recent EU Codes webinar was excellent. Rina presented a very complex and grey topic in the most clear and digestible manner – a sign of a true expert. The questions in the Q&A were sometimes a little ambiguous but Rina gave clear and relevant answers that provided real clarity.

Richard Blackwell
Medical Team Leader, Multi Tumor Franchise Roche Products Ltd

During the bid defense we felt that you worked well as team and are very dynamic. Preparation of such a complex dossier really needs to be done in such a way.

Large Pharma, Germany
VP Regulatory Affairs
USEFUL LINKS
  • Home
  • Contact us
  • Imprint
  • Data Protection
  • Terms and Conditions
RECENT TWEETS
Tweets by @PharmaLexGLOBAL
COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY
  • They are available when we need to talk to them despite any time zone differentials

    Japan based medium sized company
    Manager
PharmaLex
©2021 PharmaLex GmbH. All rights reserved.

ISO9001:2015 LogoEnergie Audit Logo

#AskTheExpert #TogetherBEYONDCOVID19





    Select your state:

    .
    You can unsubscribe at any time at data.protection@pharmalex.com

    If you do not wish to receive any communication from us, you can unsubscribe at any time at. Click here to view our Privacy Policy.

    #TogetherBEYONDCOVID19

    We closely monitor developments and updates surrounding the current outbreak of Coronavirus Disease 2019 (COVID-19) from official sources including the World Health Organisation and are following the guidance and direction of the governments and the local authorities. We are taking this situation very seriously and our number one priority is the safety and business continuity for our customers and colleagues. As ever, we will do everything we can to ensure that services are delivered within the required time and the trusted quality PharmaLex is known for

      Please DO NOT send us event/conference information.
      We will not respond and these will be deleted immediately.





      Select your state:

      .
      You can unsubscribe at any time at
      data.protection@pharmalex.com

      If you do not wish to receive any communication from us, you can unsubscribe at any time at. Click here to view our Privacy Policy.

      Privacy Policy

      This can be specific information about signing up to the newsletter.

      Pellentesque lobortis, tellus at ultrices ullamcorper, lectus tellus consectetur lectus, id consequat leo quam quis eros. Mauris pellentesque tortor a augue pellentesque ultricies. Phasellus sit amet suscipit orci, vel dapibus ligula. Maecenas at pellentesque lectus, sit amet tristique felis. Integer fringilla risus ac neque mollis, at imperdiet lacus sodales. In vehicula orci sed vulputate interdum. Nunc sagittis non nunc eget sollicitudin.

      Maecenas a mattis erat. Phasellus cursus erat non nisl pulvinar ultricies. Aenean id fringilla libero. Orci varius natoque penatibus et magnis dis parturient montes, nascetur ridiculus mus. Morbi in ultrices elit. Suspendisse egestas hendrerit est. Integer pellentesque nisl ut justo tempus, nec suscipit dolor luctus. Cras vestibulum elementum tincidunt.

      In compliance with the Spanish Law 15/1999, of Protection of Personal Data and in accordance with regulations approved by the Spanish RD 994/1999 inform you that your data will be part of a file located in Friedrichsdorf (Germany), whose ownership belongs to Pharmalex Spain S.L.U. The purpose of these data is the insertion in a potential job selection process. Inform the user that at any time may exercise their right of access, rectification, and deletion of data through email curriculum@pharmalex.com or to this postal address Pharmalex Spain. Coso 103, 50001 Zaragoza, Spain.