Audit Service

QARA Tech Audits provides a dedicated service to conducting audits to relevant standards & regulations. These Audits are designed to provide (a) Gap Analysis of Company Compliance (b) Preparation for Regulatory Audit or Independent Audit.

Zahra Hyland is a qualified Lead Auditor (SAI Global certified). With over 25 Years Management experience in Global Regulatory Audits (TGA, FDA, EU, UK, Japan), Certification Audits (ISO 13485, ISO 9001, UL, Health & Safety), Manufacturing & Supplier Audits

Audits are a cost-effective approach to determining a Company or Product compliance status upfront. Supports better business planning & highlight potential compliance risk.

Our Audits can been conducted in several ways depending on the business & location of Audit. With Covid Safety & work flexibility in mind, we have an Audit format to suit all purpose e.g. Remote, Desktop or On-site Audits.

Audit Package includes:

- Remote Audits can be done virtually, desktop or hybrid of both.

- On-Site Audits possible if local or by special request

- Audit Planning, Audit & Audit Report

- Fixed costs (starting from $5000)

(dependent on Audit Type, company size & complexity)

- For On-site Audits, additional Travel expenses + Accommodation may apply.

International Regulatory Audits

-TGA, UK, EU, FDA, JAPAN

Regulatory Audits are conducted to demonstrate that Product and Company meet Regulatory Requirements. This is require for pre & post market processes.

We can (a) Review company readiness for upcoming Audit or (b) Review of Product or Company compliance status to meet International Regulatory Requirements.

CertifIcation Audits

-ISO 9001, ISO 13485, UL, CE

Many companies undergo a certification process to demonstrate Product and /or Company compliance to. Industry standards.

We provide an overview of Product & Company to meet the Standard Requirements. A compliance health check .

Manufacturer

- Medical Device, Sterile, Radio-Pharmaceutical, Software, Medicines.

Manufacturing Audits are review Product Manufacture . These audits often focus on Manufacturing Process, Equipment, Environment , Quality Assurance and/or Operations.

Manufacturers could be part of company or a contract manufacturer who provides their service to a company Also includes Contract Manufacturers

Supplier Audits

-Supplier Qualification of Product or Services

3rd Party Audits of supplier's is designed to ascertain if they are set-up appropriately to deliver good quality product & service to your company. This is usually the case when in-house expertise is not available or done to meet business requirements.

A useful Audit before committing to supplier services.