• 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.
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.
• 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.
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.