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21 CFR Part 11
  StatLIA Validation Package
Excerpts PDF File

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21 CFR Part 11 Title
 
   

21 CFR Part 11 System
Requirements

StatLIA 3.2

Audit Trails

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  Generate Secure Records of Transactions
YES
  Record Date, Time, Identity, and Transaction
YES
  Prevent Original Data from Being Overwritten
YES
  Prevent Signature of Record from Being Altered
YES
  Time-stamp of Record Must Reflect Local Time
YES
  Store Initial Raw Data from Instrument
YES
  Ability to Record Notes about Transaction
(Required for GLP Laboratories)
YES

Security

 
  User Name and Password
YES
  Prevention of Duplicate Passwords
YES
  Historical Record of Controlled Transactions
YES
  Prevention of Falsifying Electronic Signatures
YES
  Authority Checks to Verify Permitted Access
YES
  Automatic Notification of Inappropriate Access
YES
  Automatic Time-Out After Inactivity
YES
  Password Aging
YES
   

Electronic Record Systems

 
  Advanced Report Generating Capability
YES
  Display Data Electronically and by Hard Copy
YES
   

Links from Signatures to Records

 
  Maintain Signatures as Long as Records
YES
   
 
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