We are aware of the needs and expectations of pharmaceutical companies and of the auditing pressure their suppliers undergo. This led us to create a model that provides advantages to all parts delivering a high-end audit service.

We look for the best audit organization, avoiding time and efforts dealing with all the stakeholders to schedule the audits according to the sponsors’ deadlines and according the auditees’ schedule.

Once the audit is contracted by the audit sponsors, AFA dimension it, setting up the audit days – according the auditee schedule and sponsors’ deadlines-. Once the audit is arranged, we look for the best qualified auditor team àlink a Qualified auditors to best address the audit.

We take care of the entire audit lifecycle: audit preparation, execution, reporting and CAPA follow-up to allow you crossing out the audits to your suppliers from your list.

Shared Audits

Database Audits

Exclusive Audits

All information handled is strictly kept under confidential terms, including NDA or CDAs, from sponsors participating in the audit to the auditee information delivered to the audit sponsors through the personalized reports.

Auditors apply impartial criteria when performing the audits, assessing the sponsors’ specific requirements, and addressing them to the auditee.

EMA recommendations about absence of commercial relationship between auditee and auditor are reviewed during the auditor’s allocation process.

Each sponsor receive a complete report with the information related to the products of their interest and the inclusion of the revision of their specific requirements.

With local auditors all around the globe, we can perform and deliver audits to any country.

API

MedDev

Distributor

GCPs

Packaging

Excipients

Carrier

Software

Shared Audits

We know that many suppliers are used by a great amount of companies. We take advantage of our great experience and look for the most convenient solution to offer you the best price.

AUDIT STEPS

Audit request

Audit Request

Pool of customers > look for other sponsors interested > Share the cost

Set up contract and agreements with audit sponsors

Audit Preparation

Schedule the audit with auditee

Auditor team allocation

Audit preparation

Audit Performance and Reporting

Audit performance

Revision of audit report

Personalized reports sent to audit sponsors

Audit Follow-up

CAPA Follow-up

AFA remind of expiry dates to arrange follow-up audits

Database Audits

All information gathered during the audits is kept in AFA database allowing us to prepare a report under new requests.

It is easy, just inform us about the audit and product you are interested in and we will check our database and inform you about the different options:

  • Site and product audited contract
  • Site audited and product not audited contact the auditee for more information
  • Site not audited New audit

All information handled is strictly kept under confidential terms, including NDA or CDAs, from sponsors participating in the audit to the auditee information delivered to the audit sponsors through the personalized reports.

Auditors apply impartial criteria when performing the audits, assessing the sponsors’ specific requirements, and addressing them to the auditee.

EMA recommendations about absence of commercial relationship between auditee and auditor are reviewed during the auditor’s allocation process.

Exclusive Audits

Facing strategic projects or qualification of strategic providers? We are your partner in that specific and critical activities.

In that specific case all information is kept under strict confidential terms and you will be the unique recipient of any information related to that specific project.

All our auditors have a great experience, and they nurture their background through several high-level consultancy activities performed to the most relevant pharmaceutical companies.

We have helped customers all around the globe adapting the projects to the specific regulations applicable in each country.