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Facility Management Compliance

Many times the facility portion of a Life Sciences company is overlooked. While in reality, it is extremely important. Facility Management Compliance includes areas such as energy generation, environmental monitoring, clean room monitoring, cleaning procedures, security, and more! USDM has hands on experience with SME’s that have come from the facility world and understand what needs to be done to be compliant and understands the technical details surrounding the facility portion of a Life Sciences company and the associated facility systems!

These systems are best analyzed by direct comparison of output, including in-house gases used in production, WFI, Temp/RH and security system analysis with predicate rule and CFR Part 210, 211.

Examples include:

  • Utilities, Facilities, Water Systems, Building Management Systems, Site Security
  • Contract Manufacturing Organizations (CMOs) audit
  • Emergency Power Failover Assessment
  • Facility Management System Qualification    
  • Building Management Qualification System
  • WFI/Purified Water System Qualification
  • Controlled Substances security, management and accountability
  • Classified Substances Cage/Vault Qualification