Quality System

“Be compliant”

quality management system (QMS) is a collection of business processes focused on achieving quality policy and quality objectives to meet your requirements. It is expressed as the organizational structure, policies, procedures, processes and resources needed to implement quality management.

We offer you

  • Due diligence process
  • Project management and oversight
  • Establishment of Quality System in different departments: Quality Manual, Standard operating procedures, Working instructions, Trainings of personnel
  • Compliance with GxP guidelines
  • Overview and detection of key personnel in organizational structure
  • Quality review process (QC/QA)
  • Preparation of Risk minimisation system
  • Performance of Audits (regular audits, pre-inspection audits)
  • Setting up appropriate Contractual arrangements and supervision

Establishment of Quality System in Regulatory Affairs to ensure effective communication and information flow between internal and external partners, which has the key impact on overall business process and inspection outcome.