secure state-of-the-art fully-compliant

Facilities

LegalSafe -Two great facilities – one in Boston, MA and two in the Princeton, NJ area.

The modern dedicated storage facilities are designed with the following attributes:

  • Temperature controlled rooms and chambers for evidence storage
  • All chambers/rooms are monitored with a sample monitoring system that ensures chambers maintain designated conditions
  • IT Infrastructure backed up offsite
  • Backup Power at all facilities with Automatic transfer switches in the event of power outages
  • Secure facilities featuring
    • DEA Schedule II Alarm System with Cellular Backup
    • Closed Circuit Television in all facility areas including motion recording and night vision
    • Motion Sensors in all areas
    • Controlled card scanning access with full entry log
    • All chambers individually locked with padlocks and keys stored in safe
    • Flood Sensors
    • Smoke Alarms
    • Fully sprinklered facilities
  • Low Crime Locations
  • Geologically stable and climatically low risk locations
  • Close to major interstates and airline hubs for easy transport of client samples globally
  • Contingency plans ensure a rapid and effective response to emergency events

Current Compliance Standards and licenses

All systems within LegalSafe relate directly to cGMP (Good Manufacturing Practices) and LegalSafe’s 64 dedicated Standard Operating Procedures adhere directly to this industry standard.

  • FDA registered and audited for HCT/Ps (Human Cells, Tissues, and Cellular and Tissue Based Products CFP – compliance to 21CFR Part 1271)
  • ICH stability testing per Q1A
  • cGMP (Current Good Manufacturing Practices)
  • GLP (Good Laboratory Practices)
  • GSP (Good Storage Practices)
  • GTP (Good Tissue Practices)
  • 21 CFR Parts 11, 58, 210, 211, 820, 1300
  • ISO 9001:2008 Compliant
  • IATA Compliant for transportation (trained staff)
  • DOT Compliant for transportation (trained staff)
  • Sample Management software – 21 CFR Part 11 compliant (full audit trail)
  • Sample Monitoring Software – 21 CFR Part 11 compliant (full audit trail)
  • Employee Training records software – 21 CFR Part 11 compliant (full audit trail)
  • SOP Management Software – 21 CFR Part 11 compliant (full audit trail)

LegalSafe maintains 64 Standard Operating Procedures (SOP’s) which cover all aspects of the business including Facility Management, Quality Management, Equipment Management, Controlled Substance Management and Sample Management. These procedures are essential to maintaining compliance with all regulatory bodies and our clients’ stringent requirements. Our daily business practices are incorporated into the SOP’s along with the regulatory requirements to guarantee proficient procedures. The SOP’s are the building blocks to managing the pharmaceutical, medical device, biological, and controlled substance areas of our business.