Audit

To ease your audit workload and/or bring our expertise to areas requiring specific skills, we offer to organize and conduct audits on your behalf.

This can include audits of your suppliers and subcontractors (in France, Europe, and internationally), as well as your internal audits.

When needed (due to geographical, geopolitical, health-related, or other constraints), the audit can be conducted remotely.

We also offer support in conducting a self-assessment of your site, making it available to your clients.

If your site is frequently audited by your clients, we can help them consider a shared audit approach, which we will carry out while addressing each client’s specific question. Each client will receive an audit report customized to its scope and needs.

If you are a client of a site to be audited, opting for a shared audit can help you reduce costs, as they are splitted between the various clients.

> 100 audits performed (France and international)

Consulting

We offer to assist you in implementing or improving your quality management system, preparing for your certification audits, and/or GMP and GDP inspections.

We help you establish clear and efficient processes and aim for a quality level that best meets regulatory and normative requirements, as well as your clients’ expectations.

(Over-quality demands significant human and financial resources without necessarily adding value.)

Management de Transition

Need interim or operational management?

We are available to step in and ensure the continuity of your operations. Our enthusiasm and dynamism will energize your teams and drive progress.

Here are the roles we specialize in:

Supplier Quality Assurance

• Selection, evaluation, and qualification of suppliers and subcontractors
• Development of the annual external audit program and supervision of auditors
• Drafting of specifications and quality agreements
• Handling supplier complaints
• Impact assessment of supplier change notifications
• Drafting, improving, and approving procedures
• Preparing internal audits, certification audits, and inspections

Operational Quality Assurance

• Handling deviations
• Handling change control processes
• Implementing remediation plans following inspections

Training

We provide on-site and cross-site training on quality assurance topics, based on ISO standards or GMP/GDP guidelines.

The training sessions can be structured into different modules and conducted either on-site or remotely (via video conferencing).

Each participant will receive:

A certificate of participation or achievement (based on a quiz evaluation).

Comprehensive training materials.

> 50 people trained (via Cefira)

Translation

Are you an international group and/or do you work with international suppliers or clients?

We offer translation services for key documents in your quality management system, from English to French or vice versa. This includes your quality manual, procedures, work instructions, technical documents, and even regulatory files.