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21 CFR Part 11
GLP Archiving
 
 
 
 

GLP Archiving

QAI operates a state-of-the-art secured GLP archive facility.  Our archive facility is located in a brick building, and is equipped with a full Halon fire suppression system including an early warning fire detection system.  The archivists are GLP consultants of the Quality Assurance & Scientific Support Division.  The entire archive facility is controlled by QAI’s own standard operating procedures (SOPs).  The archives facility has been inspected by FDA for GLP compliance in 2003, with “no action indicated” (NAI) and no 483.

We can provide long-term or temporary storage of:

  • Documents
  • Tissues, blocks and slides
  • Refrigerated and frozen samples
  • Radioactive metabolism samples
  • Electronic media

QAI's archive facility provides the following:

  • Attached directly to QAI's offices
  • Limited and controlled access
  • 24-hour Security and Fire Systems Monitoring
  • Halon Fire Suppression System
  • Laser smoke detection system with multiple ports for sampling throughout archive
  • Environmentally controlled (temperature & humidity)
  • Temperature and humidity monitored
  • Storage information maintained on database
  • Electronic imaging of reports and data

 

 
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