Quality Management System

Effective quality management improves performance of company's resources by avoiding delays and losses due to eliminating inconsistencies and reducing regulatory risks and, as result, reduces time and costs of clinical trials.

Smooth Drug Development has implemented and maintains a quality management system according to the standard ISO 9001 "Quality Management Systems – Requirements" for all aspects of operations. The main features of the standard are process approach, risk and change management, vendor management, quality control and a cycle of continuous improvement.

The quality management system includes quality assurance and control, risk assessment, monitoring of processes, training system, work permit and regular assessment of personnel.

Employees are regularly trained in GCP and other guidelines of ICH, local regulations, as well as standard operating procedures of the company. After the training they pass knowledge testing.

The quality management system includes:

  • Quality Policy
  • Quality Management System Guide
  • Quality Objectives
  • Company Organizational Structure
  • 100+ Standard Operating Procedures
  • 330+ Instructions and Standard Forms
  • Job Descriptions
  • Personnel Training Program
  • Internal Audit Program
  • Process Monitoring Plan
  • Vendor Audit
  • Customer and vendor feedback analysis

The company is ISO 9001 certified by IAF members since 2014. Compliance with the requirements of the ISO 9001:2015 "Quality Management Systems" standard is confirmed by the international company G-CERTI.

Comparison of quality management systems

System elements Basic QMS Advanced QMS Smooth QMS
Human resources management
Standard Operating Procedures
Employees’ personal files
Work permit and employees’ performance assessment
Records administration
Vendor management
Training and performance control
Internal quality audit
Clients’ satisfaction analysis
Process approach
QMS manual
Quality goals, management leadership
Risk management
Changes management
Processes monitoring

Smooth Drug Development conducts clinical trials in Eastern Europe, Central Europe and the Commonwealth of Independent States.