Quality management system

Smooth Drug Development – Quality management – CRO Russia, CIS and Baltic States

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 9001:2015 "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 Management System Guide
  • Quality Policy
  • Quality objectives
  • Organizational structure of the company
  • Standard Operating Procedures
  • Instructions and standard forms
  • Job Descriptions
  • Personnel Training Program
  • Internal Audit Program
  • Process Monitoring Plan
  • Vendor audit 
  • Customer and vendor feedback analysis

In 2014 Smooth passed its first certification according to ISO 9001:2008 "Quality Management Systems – Requirements" done by EUROCERT Α.Ε.

In 2017 our company successfully passed the certification for compliance to the new standard ISO 9001:2015.

Comparison of quality management systems

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
CAPA
Clients’ satisfaction analysis
Process approach
QMS manual
Quality goals, management leadership
Risk management
Changes management
Processes monitoring