cGMP services-2-min

The support you need

Our dynamic environments are supported by a full spectrum of operational services. Beyond our advanced eQMS, SmartLabs customers benefit from expert support in operations, compliance, facilities management, workflow planning, IT infrastructure, and a host of administrative services — allowing your teams to stay focused on the science. Our range of customizable manufacturing service solutions is listed below.

Tailored cGMP programs for facility and cleanroom management

  • Commissioning, qualification, and validation (CQV)
  • Process gas supply and monitoring
  • Building systems and utilities validation
  • Critical utility maintenance
  • Cleaning and disinfection
  • Contamination control
  • HVAC preventive maintenance
  • Environmental monitoring (routine and in-operation)
  • Environment, health, and safety
  • Waste management (hazardous and non-hazardous)
  • Stocking of PPE and cleaning reagents
  • Cleanroom & aseptic training

Material program support

  • Receipt and quarantine of materials
  • Controlled storage
  • Tracking and distribution
  • Material cleaning and transfer
  • Sample management

Quality program support

  • Investigation and corrective and preventive actions (CAPA)
  • Change management
  • Risk management
  • Audit readiness and compliance monitoring
  • Permitting and regulatory compliance