Quality and Regulatory Compliance Policy

ClinSoft is committed to achieving the highest standards in its operations and interactions.   ClinSoft Quality and Regulatory Compliance Policy outlines the Company’s top level requirements to support quality and compliance in the development and distribution of its products and services.

In accordance with this Quality and Regulatory Compliance Policy, the development and distribution of Company products and services are  conducted in compliance with relevant International Codes,  Standards and  GxP quality guidelines and regulations (Good Laboratory Practice, Good Clinical Practice, Good Documentation Practice). ClinSoft also is adherent to considering and satisfying local regulatory requirements, as well as the requirements of the countries to which products and services are to be supplied.

ClinSoft runs the Quality Management System (QMS) that documents processes, procedures and responsibilities for achieving quality policies and objectives and ensure that processes, skills and controls are used and applied in a consistent manner. It helps coordinate and direct the Company’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

In particular, ClinSoft’s QMS is based on the following standards and industry regulations:

  • ISO 9001:2015 Quality Management System – Requirements;
  • ISO/IEC 27001:2013 Information Technology – Security Mechanisms – Information Security Management Systems – Requirements;
  • ISO/IEC 27701:2019 Privacy Information Management System – Requirements and guidelines;
  • Good Clinical Practice (GCP);
  • Health Insurance Portability and Accountability Act (HIPAA);
  • General Data Protection Regulation (EU) 2016/679 (GDPR);
  • Code of Federal Regulations Title 21;
  • International Council for Harmonisation (ICH), etc.

The Policy covers also the following important aspects:

  1. Company Structure and Staff: administrative and functional units have high quality staff with the appropriate education, training, skills and experience to carry out their work competently. All personnel have written and up-to-date job descriptions that clearly outline responsibilities and qualifications. Management responsibilities are clear and staff in key positions have appropriate authority.
  2. Facilities, Equipment and Computerized Systems: facilities, equipment and computerized systems are designed, constructed, installed, qualified, maintained and decommissioned as appropriate to their intended use, and in compliance with the applicable standards and regulations. Any changes to facilities, equipment and computerized systems must be defined and controlled. Access to, and security of, facilities, equipment and computerized systems are defined and controlled.
  3. Data Integrity: all paper, electronic or other data, documentation and information are managed and maintained in accordance with the applicable standards and regulations.
  4. Audits and Inspections: audits of internal activities, external parties, suppliers and contractors are conducted by sufficiently independent individuals who possess the skills to assess compliance with applicable standards and regulations.
  5. Control of Externally Provided Products and Services: the Company is responsible for ensuring that the purchased supplies and systems meet applicable standards and regulations.
  6. Issue Management: the Company has the system of monitoring the operational environment for identifying issues and trends, adapting to changes and making decision on managerial or communicative actions for creating mutual understanding with relevant stakeholders.