21 CFR Part 11 Compliance


Regulated laboratories use different types of instruments. Not all instruments have software with features enabling 21 CFR Part 11 compliance.

LogiLAB for 21 CFR Part 11 Compliance

Several laboratories have adopted LogiLAB as the solution which might be due to one or more of the following points.

  • Closed system
  • Electronic signature support
  • Independent of the instrument (manufacturer/ model)
  • Database & server oriented (no raw or meta-data storage in local PC)
  • Control over electronic records – a full audit trail of events
  • All instruments – 1 solution
  • CFR Gateway – for Non-Compliant Instrument

Non-compliant instrument software has a few issues such as

  • No user, roles and rights or security (controlled access)
  • Stored data accessible & modifiable
  • No audit trail of events

How does the CFR Gateway work?

CFR Gateway Module
  • CFR Gateway, when installed on windows, is a primary gateway
  • Only authorized users can login
  • Login/Log0ff is audit trailed with date & time stamp
  • After login, only authorized applications are viewable (non-compliant software)
  • Non-compliant software can be run from Gateway application launcher
  • Files generated are constantly monitored & moved to the server
  • No access to files on local PC, downloadable from server
  • Modified files moved to server with versioning
  • The system consistently protects electronic records

How LogiLAB SDMS with CFR gateway ensures 21 CFR compliance?

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