Audit Service Center

An audit is defined as a “systematic, independent and documented process for obtaining audit evidence, evaluating it objectively to determine the extent to which the audit criteria are fulfilled”.

We deliver comprehensive audit services with the aim of achieving regulatory inspection readiness for our customers. In addition we provide continuous quality improvements and financial gains by adopting holistic approaches and state-of-the-art tools. 

Our services encompass the entire audit lifecycle from audit concepts and programs to measurable audit results and corrective actions. We perform audits and assessments on behalf of our customers solely or jointly with them, for example of vendors and service providers like CMOs, CROs, APIs, excipients, materials, single-use technology, components, services and/or contract manufacturers. We further support outsourcing or specific project decisions by performing IT (e.g. 21 CFR Part 11) audits, project status audits, mock audits, due diligence assessments, distribution audits and shared audits.

It is the aim of the Audit Service Center to offer independent and 'turnkey' GxP compliance audits of manufacturers and/or distributors, including audit planning, performance, review and CAPA. Our services are used by different local and global (multi-sites) companies and suppliers. Read more at FOR SUPPLIERS

The regulated industry is faced with increasing legislation and requirements on efficacy, quality, and safety during the entire life cycle. As a result, quality and compliance units are expected to control compliance of the entire supply chain, from incoming goods and materials to the delivery of final products (Good Distribution Practice).

Within the framework of the Audit Service Center audits of the same supplier can be initiated by one or several manufacturing authorisation holders in order to get independent information about the GxP compliance status of the supplier and prepare for regulatory inspections. Audits can also directly be initiated by a supplier or vendor.

We provide tailored audit services to the suppliers and vendors of the pharmaceutical, medical device and cosmetics industries.

Promoting a compliant corporate culture with the supplier

 Audit Service Center for Suppliers: 

 All suppliers of products and services to the entire life science industry are concerned.

We offer a free and easy way of registration in the Audit Service Center. A supplier may face more than 20 client audits per year often dealing with the same products and standards. Therefore a standardized approach to these audits offers great time and money savings.

As a supplier to the GxP regulated industries you execute only once the postal audit and are able as a result to produce the certificate of performance of the postal audit to each customer requesting an audit. In addition we will help you to organize shared client audits.

Contact us for more information about the online postal audit at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .