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.
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).
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.
- SOCMA Quality Agreement Template (View PDF)
- SOCMA Custom Quality Agreement (View PDF)
- IPEC Quality Agreement (View PDF);
- APIC publications (incl. Auditing): Full listing and The Audit Programme, Version 3, Update July 2012
- Rx-360 Supply Chain Consortium: Guidelines and Templates - Download