Area of expertise

Human and Veterinary Drug

  • Good PharmacoVigilance Practices
  • Good Practices Clinical
  • Good Distribution Practices
  • Promotional Information

Medical Device

  • Good Medical Devices VIgilances Practices
  • Quality Management System (ISO 13485)

Cosmetic Product

  • Good CosmetoVigilance Practices
  • Good Manufacturing Practices (ISO 22716)

Audits

Auditing is a key tool for verifying compliance with requirements and ensuring continuous improvement, the basic principle of all efficient quality systems.

Rich in many years of experience in the realization of systems audits, both at the level of parent companies, subsidiaries, distributors and partners, AUDITHEM offers its expertise in the implementation of audits.

The audits are carried out according to the methodology adopted by the authorities during the inspections. They are not only tools for monitoring compliance and improving processes, but also a mean of preparing the organisation for inspections carried out by the authorities.

Each of the key processes is evaluated on the basis of the information gathered from the audited organization, the documentation available, such as the procedures, working instructions and corresponding records and the review of practical cases. Thus, the main objectives are to check whether appropriate measures are in place for each process, and whether they are properly and systematically implemented and documented in accordance with the requirements.

AUDITHEM is able to accompany its customers throughout the process, or according to its needs at one or more stages of the audit process.

Planning

  • Identification of risk areas and critical processes
  • Definition of frequency and order of priority established on a risk-based approach

Preparation

  • Acknowledgement of a certain number of documents that have been previously sent to the auditor
  • Elaboration of a detailed and adapted agenda which takes up each of the processes to be audited and the time corresponding to devote
  • Transmission of the agenda between 30 and 15 days before the audit

Conduct

  • Opening meeting to present the objectives and revise the agenda, if necessary
  • Interviews with key people in audited processes and review of documents and evidences
  • Closing meeting at which the identified observations are presented and discussed
  • Transmission of an audit certificate

Reporting

  • Preparation of a detailed report presenting the identified observations and findings, their context, their grading and the references of the enforceable standards
  • Transmission of the report between 30 and 15 days after the audit

Validation & follow-up

  • Validation of the actions plan proposed by the organisation
  • Follow-up of the implementation of the actions according to the deadlines announced for the resolution of the findings

The team

Audithem met à disposition des consultants

Independent
Activity implemented within an autonomous unit to ensure total independence
Qualified
University Degree of auditor for health industries / Academic training in the field of science (chemistry and biochemistry), vigilances and quality assurance
Experienced
+ 50 Audits with their assets in 2018 / Consultants with professional experience in the field of vigilances and product & system quality assurance
Multilingual
French, English, Portuguese, Spanish, German
With a master's degree in analysis and quality, Laurence worked over 4 years as quality assurance Manager for a manufacturer of sterile implantable medical devices of classes Is and III. She joined the company AXPHARMA in June 2015 and held the positions of quality auditor and quality assurance Director. Laurence intervenes at the University of Health Sciences of Dijon and at the University of Paris Descartes on the fields of pharmacovigilance and audits. Since July 2018, she dedicated herself to the development of the auditing activity and the implementation of these audits on behalf of the health industries and also intervenes as a trainer within AXACADEMY. Laurence has obtained her quality auditor certifications in the pharmaceutical industry and internal and external auditor of the cosmetic sector and has about fifty audits to its credit worldwide as the main auditor.
Laurence RICHARD
Senior Quality Auditor, Head of Development & Operations

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