Quality Management

Commitment to quality

Accovion is committed to uncompromising quality in all areas of our business. We conduct projects and activities efficiently and in accordance with international quality standards, best practices and ethical principles to ensure that our clients and regulatory authorities are provided the best possible services and products.

The Accovion Quality Management System

To comply with international quality standards, best practices and ethical principles, Accovion designed a Quality Management System. This system ensures that all operations and projects adhere to regulatory requirements and guidelines, such as:

  • US 21 Code of Federal Regulation relevant sub parts
  • EudraLex Volume 10 Clinical Trials guidelines
  • Principles of Good Clinical Practice
  • ICH guidelines
  • Other industry standards

The Accovion Quality Management System consists of the following elements:

  • Quality assurance
  • Well structured organization with highly qualified personnel
  • Detailed Standard Operating Procedures (SOPs) describing responsibilities and duties
  • Regular audits
  • System improvement and consultancy

The Accovion Quality Assurance department

Our Quality Assurance (QA) department is an independent unit reporting to the CEO of Accovion. The department’s main focus is the continual improvement of Accovion’s Quality Management System to ensure the required quality fulfillment.

Accovion’s SOPs contain quality control mechanisms and our Quality Management System requires that SOPs (either ours or yours, if requested) are followed to ensure Good Clinical Practice compliance.

Our clients regularly conduct audits of our well structured Quality Management System. We have successfully passed all external client audits. Accovion conducts an Internal Audit Program in all areas of our business to maintain our excellent reputation for quality and compliance.

Involved in every step of clinical development, Accovion’s QA staff ensures that your projects will receive the highest level of quality and efficiency. System improvement and consultancy is given on a continuous basis to all Accovion personnel and to clients as requested. Our QA personnel maintain an optimal level of knowledge through ongoing continuing education and regular participation at QA and other conferences.

Gisela Hettwer

Gisela Hettwer
Director Quality Assurance

+49 6196 7709-442

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