Computer systems with reference to 21 CFR part 11

1
Computer systems with reference to 21 CFR part
11
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Computer Systems with reference to 21 CFR part 11

• Lundbeck approach
• Corporate Guideline for Computerized GXP Systems
  Life cycle
• Business critical and GXP systems
• part 11 compliant
• Pluto
• Ludo
• SAP

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Computer Systems with reference to 21 CFR part 11

• Corporate Guideline for Computerized
• GXP Systems Life cycle
• A computerized system for use in a
  GXP-regulated process must be validated and kept
  in a validated state during its entire life

4
Computer Systems with reference to 21 CFR part 11

• Overall requirements
• Validated
• Audit trail
• Controlled user administration
• Security
• Maintenance
• Trained users (documented)

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Computer Systems with reference to 21 CFR part 11

• Validation
• Generation of essential documents (VMP
  specifications)
• Test protocols (IQOQPQ)
• Testing
• Controlling documents (SOPs)
• Reporting
• Change management!

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Computer Systems with reference to 21 CFR part 11

• SOPs for system
• System installation
• Data collection handling
• System maintenance
• Data backup, recovery and contingency plans
• Security
• Change control

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Computer Systems with reference to 21 CFR part 11

• Logical security
• User administration
• Access
• to individual system and networks
• to functions and data
• Retire accounts of personnel leaving
• Passwords
• No re-use of passwords
• Password change enforcement
• Number of unauthorised attempts before disabled
• Lock out period

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Computer Systems with reference to 21 CFR part 11

• Logical security
• Screen saver/log off when workstation is left
  unattended
• Audit trail
• Virus prevention/detection
• Firewall

9
Computer Systems with reference to 21 CFR part 11

• Physical security/server room
• Access security
• UPSs
• Fire detection/protection
• Temperature/humidity control
• Cleaning
• Server logs/monitoring