Pharmaceutical Equipment and Software System Verification

Medicine is a kind of special commodity related to human health care and healing. Its quality is directly related to the efficacy of drugs and people's health and life safety. As the necessary equipment for drug production, pharmaceutical machinery has a close relationship with the quality and safety of drugs. GMP clearly stipulates that drug manufacturers should carry out product and process verification of pharmaceutical equipment. The newly purchased equipment of the pharmaceutical factory cannot be put into use if it is not verified or has not passed the verification, so the verification of pharmaceutical equipment is mandatory.

Computerized system validation (CSV) is a process of comprehensive verification and validation of a computerized system to ensure that the system meets regulatory requirements and quality standards while meeting expected performance and specifications. It covers steps such as verification plan, user requirement specification, functional / design specification, design confirmation, risk assessment, factory / field acceptance test, installation / operation / performance confirmation, verification report, etc. CSV is commonly applied to computerized systems used in pharmaceutical, medical device, biotechnology, and other regulated industries, including software applications, hardware devices and related facilities.

STEMart provides you with high-quality pharmaceutical equipment and software system validation services in accordance with industry regulations and guidelines and based on user needs.

Service Items

• Equipment verification
  • Refrigerator
  • Incubator
  • Stability box
  • Sterilization cabinet
  • Cold storage
  • Room temperature storage
• Analytical instrument and computerized system validation
  • Analytical instruments and workstations
  • Large laboratory management systems

For more information about our pharmaceutical equipment and software system verification services, please contact us.