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 meet the highest quality standards.

Biokinetica has implemented a Quality Management System and adheres to all activities in accordance with the provisions of this quality policy as well as ensuring 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 abovementioned requirements with full compliance of operations with GCP guidelines and industry best practices.

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Quality Assurance and Quality Control