As freelance auditor I can execute both internal and external audits on your behalf, my specialties are supplier audits and detailed assessments of facilities, services and quality systems.
Purchasing equipment, software or services brings a series of risks to regulated, pharmaceutical companies. I can help manage that risk by executing an audit of the supplier or by performing an assessment of the product your company wishes to purchase.
- Supplier audits allow for a complete evaluation of the supplier organisation, quality system, technical capability and key practices. A typical supplier can be audited in only two working days, with little preparation time thanks to the Corelas audit toolbox.
- An internal audit of your facility, service or quality system by an external consultant can identify issues which would remain undiscovered when relying just on internal auditors. I can manage audits at your company in all discretion, in different fields of expertise.
Efficient supplier audits with Corelas audit toolbox
I have developed a supplier audit toolbox which includes a standard audit questionnaire. The following chart summarizes my supplier audit approach as a freelance auditor.
I can manage the above audit process completely on your behalf, and perform the on-site audit using an in-house developed questionnaire. Of course the audit approach can be adapted to your expectations, or can be performed following your organisation's own approach to supplier audits.
Experience as freelance auditor
The past years I have executed more than 20 postal audits and 10 on-site audits for suppliers of equipment, software and services, and at customer locations. On-site audits were executed during 1 or 2 days, and covered the following topics:
- Organizationational structure
- Company history and viability
- Site security
- QMS (general)
- Document control
- Internal audits
- Suppliers & subcontracted activities
- Product lifecycle
- Requirements & design
- Programming / Construction
- Testing / Verification
- Change control
- Manufacturing (commercial products)
Furthermore I have executed over 50 compliance assessments regarding 21CFR Part 11 and Eudralex annex 11 for commercial and custom built systems and software.