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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.
 
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 (Contract Acceptors): All suppliers of products and services to the entire life science industry are concerned (e.g. refer to EU GMP Chapter 7).

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.

The Audit Service Center uses the "Plan, Do, Study, Act" (PDSA) methodology for managing the audit process. 

Proven audit techniques and strategies deliver value-added quality audit results.  

Set up of quality agreements and review of quality processes: The “Plan” step will identify your supplier compliance and improvement goals, optimize audit programs and procedures, and define actionable strategic decision systems and key performance indicators.

We will also review previous audit reports and findings, deviation records, and your CAPA process.

The basic process steps for successful audit management are:

  • Audit program set up
  • Audit schedule and planning
  • Audit performance
  • Audit reporting
  • Audit results monitoring and CAPA process.

Our web-based audit database solution contains document management features and integrated workflows for audit scheduling, documents & specifications management, status and task reporting, and results monitoring / CAPA process. We deliver Audits and Results with the Best Industry Practices.

The process diagram highlights the basic workflows of audit management which are fully integrated into our audit management tool. This process diagram derives from our experience in setting up and performing audit programs. Customized extensions, changes or interfaces (DMS, ERP….) are readily available.

Supply chain excellence has a real impact on business, quality, and compliance strategy. Supply chain management supported by quality audit management is a high impact mission that goes directly to the roots of a company’s very competitiveness. High-impact supply chains win market share and customer loyalty with quality products, create shareholder value, extend the strategic capabilities and reach of your business.

The Audit Service Center is a proven key to success for supply chain excellence and can yield a 25-50% reduction in total supply chain costs.

In an effort to standardize quality agreements for active pharmaceutical ingredients (APIs) in the drug industry, the Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), has developed a template to help manufacturers and customers comply with regulatory requirements in a simplified manner. The ASC team is using the SOCMA template for setting up quality agreements between clients and suppliers.

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