A new Audit Concept

A new Audit Concept

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ABOUT AUDINNOVA

Audinnova is a new audit concept that emerges from the shared vision of Azierta, Qualipharma  and Maas & Peither on the need for a model of audits aligned with the current environment and the real needs of the clients, with know how, closeness and added value. Our mission is to align ourselves with our customers, being aware of the challenges imposed by a constantly changing environment, and providing quality solutions at reasonable prices.

QUALITY SYSTEM ASSESSMENT

The basis of these evaluations is to perform a GAP analysis of those laboratories internally implementing a quality system.

This audit can be performed at the beginning of the project, during the implementation process or as a result of deficiencies detected by the laboratory itself or by a third party. The result of this audit will be an action plan to achieve certification in the quality system.

  • GMP quality system assessment Part I or II
  • GDP quality system assessment (API or medicinal products)
  • ISO UNE-EN-ISO22716 quality system assessment (Good manufacturing practice (GMP) of cosmetics)
  • EISO13485 quality system assessment (Medical Devices)
  • ISO 15.378 quality system assessment (Immediate packaging material)

AUDINNOVA TEAM

AUDINNOVA TEAM

Audinnova has a group auditors with proven experience in healthcare industry.

We also have local partners in Asian markets (India, China and Southeast Asia) to ensure optimal development of audits performed in this geographical area.

In the team of auditors we have, among others, the following Senior Auditors:

Alberto Carazo

Alberto Carazo

Technical and Commercial Team Responsible

Pino Cabrera

Pino Cabrera

GMP/GDP Senior Audito

Miguel Alcántara

Miguel Alcántara

GMP/GDP Senior Auditor

Javier Soler

Javier Soler

GDP Senior Auditor

Carlos Fernández

Carlos Fernández

Senior Auditor, Computer Systems and Data Integrity

Raquel Buitrón

Raquel Buitrón

GMP/GDP Senior Auditor

Cristina López

Cristina López

GMP/GDP Senior Auditor

Carmen Árques

Carmen Árques

Pharmacovigilance, Senior Auditor

Lourdes Vallejo

Lourdes Vallejo

GLP/GMP Senior Auditor, Control Laboratories

Miguel Ruiz

Miguel Ruiz

Engineer and Hygiene and Safety Senior Auditor

Inés Bargueño

Inés Bargueño

Audits coordinator

María Ansuategui

María Ansuategui

Quality systems Manager

METHODOLOGY

1. Kick-off Meeting

Meeting with client to collect the required information for the audit.

  1. New provider or follow-up
  2. Technical Agreements
  3. Previous Audits
  4. Observations and CAPAS status
  5. Historic
  6. Specifications
2. Audit Execution

After the information collection the audit is planned and executed.

  1. Submission of the previous questionnaire to the provider (new provider)
  2. Agenda setting
  3. Audit Execution
  4. Audit summary
  5. Final report and conclusions
3. Audit Follow-up

After final report is sent:

  1. Submission to provider of a summary of observations
  2. Consensus with provider on CAPAS to perform
  3. Periodic follow-up of CAPAS until closure