The Lifecycle Management Strategy establishes a structured approach for managing the complete lifecycle of automated control systems — from initial design through ongoing maintenance and eventual retirement. It ensures long-term sustainability and provides essential context for all engineering work processes.
The lifecycle management process incorporates a structured software development model. The V-Model (from GAMP 5) defines the relationship between development phases and their corresponding testing activities:
| Document | Purpose | Focus |
|---|---|---|
| URS (User Requirements Spec) | Defines what the system must do from the user's perspective | "What" not "how" — functional and performance requirements |
| FRS (Functional Requirements Spec) | Translates URS into system-level functional logic | Control philosophy, modes, sequences, interlocks, alarms |
| DDS (Detailed Design Spec) | Technical implementation details of the FRS | PLC logic, I/O lists, HMI screens, tag naming |
The URS focuses on the "what" — specifying what the system must do and the performance standards it must achieve — not the specific implementation methods.
The Lifecycle Management Strategy consists of two major components that work together:
A lifecycle instance is a single complete execution of the automation process — from planning through commissioning and operation. Instances can range from:
Each lifecycle instance begins when a new project starts or when significant changes are made to the Physical Model, Procedure Specification Model, or Procedure Implementation Model.
The lifecycle operates as a recursive process — information from later stages feeds back to earlier processes for incorporation in future procedure development. Both agile (short development cycles) and waterfall (sequential phases) methodologies are acceptable.
The Procedure Owner shall incorporate a Lifecycle Management Strategy into its operating organization's methodology.
The Procedure Owner shall implement an iterative review process (continuous improvement) — continuously monitoring system performance, identifying deviations, and making adjustments.