Auditing

Auditer - Auditing

You are:

•   A company in the life sciences industry

You want to:

•   Increase the performance of your Quality systems;

•   Prepare for your upcoming Quality audits to ensure a successful outcome;

•   Assess your compliance;

•   Respect internal and/or external audit schedules;

•   Select and assess your subcontractors and suppliers with complete confidence;

Cefasys offers the guidance and support you require to manage your audit programs, using audit methods consistent with the ISO 19011:V2012 standard.

Our services:

Internal audit

Cefasys can conduct internal audits to ensure your organization’s compliance with required standards. Depending on the standard to be met, our audits may take the form of:

•   Study audits, including the audits of study reports in accordance with good practices (GxP);

•   Procedural audits based on GxP;

•   Process audits to ISO 9001, ISO 17025 or ISO 15189 standards;

•   Cefasys conducts internal, targeted audits to help you assess and improve a process or procedure.

Audit subcontractors/suppliers

•   Cefasys can conduct regular evaluations of subcontractors and suppliers to check compliance with contractual obligations, in accordance with the relevant standards.

•   Cefasys can work with you to help you qualify, select and manage your subcontractors and suppliers based on GxP or ISO 9001 and 17025/15189 criteria.

Mock/diagnostic audits

The steps of an audit:

•   Preparing for the audit – defining objectives, choosing the relevant standard or regulation, performing a documentary review and drafting the audit plan.

•   Audit activities on site;

*   Opening meeting, on-site audit and interviews;

*   Visits and documentary review, review meeting and closing meeting;

•   Writing up and completion of the audit report.

•   Action plan follow-up

We conduct our audits:

•   With openness, diligence and integrity;

•   By observing and respecting all relevant legal and normative requirements;

•   In an unbiased manner and without influence from interested parties.

Vous souhaitez préparer et réussir votre prochain audit ? Vous voulez évaluer vos fournisseurs ? Vous avez besoin d’évaluer votre conformité ?

Discutons-en ensemble.

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