Doc: ps2001-5-1101-001 Rev: R02. 00

Document Outline

• Title page
• Licence
• Authorisations
• Revision history
• Contents
• 1. Introduction
  • 1.1 Scope and purpose of this document
  • 1.2 Ownership, status & relationship to other documents
    • 1.2.1 Ownership of the document
    • 1.2.2 The status of this document
    • 1.2.3 Relationship to other documents
• 2. An overview of the Project
  • 2.1 A description of the Project
    • 2.1.1 Standard Modules
    • 2.1.2 Application Modules
    • 2.1.3 Other module types
      • Template modules
      • Document modules
  • 2.2 Objective and benefits
  • 2.3 Regulations and standards
    • 2.3.1 GxP requirements
    • 2.3.2 Regulations, legislation and standards
  • 2.4 Background to the Project
  • 2.5 Scope and limitations
  • 2.6 A note on terminology
  • 2.7 Identification of requirements
• 3. Hardware operational requirements
  • 3.1 Hardware functions
  • 3.2 Regulatory requirements
  • 3.3 Environmental requirements
    • 3.3.1 Physical conditions
    • 3.3.2 Physical security
    • 3.3.3 Power requirements
• 4. Software operational requirements
  • 4.1 Software functions
    • 4.1.1 Target devices and programming applications
    • 4.1.2 Programming languages
    • 4.1.3 The software structures and organisation
    • 4.1.4 Block types and usage
  • 4.2 Standard module requirements
    • 4.2.1 Supervisory systems
    • 4.2.2 Module types
      • System functions
      • Instrumentation, analogue signals and threshold detection
      • Safety systems and interlocks
      • Mathematical calculations
      • Sequential logic control
      • Devices (control loops)
      • Devices (valves and drives)
      • Messages: alarms, warnings, events and prompts
      • Communications
    • 4.2.3 Third-party modules
  • 4.3 Application module requirements
  • 4.4 Template module requirements
  • 4.5 Document module requirements
  • 4.6 Documentation requirements
    • 4.6.1 Revision tracking and control
    • 4.6.2 Symbolic addressing
    • 4.6.3 Use of comments within the software
    • 4.6.4 Provision of documentation for the blocks
    • 4.6.5 Common style and methodology within the software
    • 4.6.6 Documentation embedded within the project
    • 4.6.7 User guide
  • 4.7 Technical requirements
    • 4.7.1 Cycle times
    • 4.7.2 Memory capacity
    • 4.7.3 Network arrangements
    • 4.7.4 Input/output rack arrangements
  • 4.8 Data requirements
    • 4.8.1 Data structures
    • 4.8.2 Data blocks
    • 4.8.3 Internal memory bits
    • 4.8.4 Parameters
    • 4.8.5 Global data
    • 4.8.6 Nomenclature
  • 4.9 Interfaces
    • 4.9.1 Common approach to supervisory systems
    • 4.9.2 Status indication
    • 4.9.3 Messages (alarms, warnings and prompts)
    • 4.9.4 Modes of operation
  • 4.10 Regulatory requirements and standards
    • 4.10.1 Regulation and legislative requirements
    • 4.10.2 Software standards
    • 4.10.3 Maintenance and publication of verification certification
  • 4.11 Environmental requirements
    • 4.11.1 Physical security
    • 4.11.2 Software security
    • 4.11.3 The protecting of software modules
• 5. Constraints
  • 5.1 Compatibility
  • 5.2 Maintenance requirements
  • 5.3 User skill level
  • 5.4 Training and support
  • 5.5 Restrictions and limits of use
• 6. References and glossary
  • 6.1 References
  • 6.2 Glossary of terms