Quality Assurance and Quality Control

Quality Assurance and Quality Control

The aim and the essence of Biokinetica’s activity is to provide customers with services and products in accordance with their requirements and to the highest quality standards.

The Management Board of Biokinetica has implemented a Quality Policy and adheres to all activities in accordance with the provisions of this quality policy as well as undertaking to ensure the conditions necessary for the implementation of its provisions are met.

All activities and products performed as part of Biokinetica’s activities are carried out in accordance with the requirements of:

  • Ethics (such as the Declaration of Helsinki)
  • Legal (such as the EU regulations and law of the Republic of Poland)
  • Industry organizational standards (such as ICH standards)
  • Quality Assurance System (such as procedures)
  • Research Projects (such as study protocol)
  • Customers (such as commercial contracts)

All activities are covered by the Biokinetica’s independent Quality Assurance System consisting of:

  • Specified procedural requirements defining the expectations of Regulatory Authorities, management and customers
  • Quality Control (QC) systems and processes, which monitor the activities carried out on an ongoing basis
  • Quality Assurance (QA) systems and procedures, systematically verifying the correctness and compliance of the processes with the requirements
  • Training program ensuring continuous improvement of qualifications and correctness of conduct

During all activities undertaken on behalf of Biokinetica and its clients, all employees, associates and subcontractors are required to act in accordance with mentioned above requirements with full compliance of operations with GCP guidelines and industry best practices.

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Regulatory & Ethical submission

A unique clinical research center in Europe with its own operating room