Computer System Design
Building computerized systems on a foundation of intended use, process understanding, and quality expectations to support effective and compliant operations.
Building the Right Foundation for the Lifecycle Ahead
Computer system design lays the groundwork for effective implementation, reliable validation, and sustained compliance. Before configuration, deployment, or testing begins, systems must be defined with clarity around intended use, operational context, process requirements, and quality impact.
At Anthem, we apply a structured, risk-informed approach rooted in Quality by Design principles. We help organizations define the functional and operational direction of computerized systems so that quality, usability, and compliance are integrated from the outset.
Process and Business Understanding
We begin by understanding the process the system is intended to support, including operational workflows, user interactions, data flows, and critical control points. This helps ensure the design approach is grounded in real business and quality requirements rather than abstract system assumptions.
Intended Use and System Purpose
A clearly defined intended use statement is central to effective system design. We help establish the system’s purpose, the scope of its functionality, and expectations for how it will be used within the regulated environment.
Requirements and Design Inputs
We help translate business and process needs into structured requirements and design inputs. This includes support for user requirements, functional expectation mapping, workflow considerations, and design review activities.
Risk-Informed Design Thinking
Design decisions should reflect system impact, process criticality, and potential compliance risk. We apply risk-based thinking early to identify areas that require stronger controls, clearer definition, or more rigorous review before downstream activities begin.
Compliance-Oriented Design Considerations
We help ensure that design activities take into account applicable expectations for electronic records, electronic signatures, audit trails, access control, data integrity, and traceability.
Design for Usability and Control
Effective system design balances operational efficiency with appropriate control. We consider user roles, workflow practicality, approval structures, and information flow so the resulting solution supports both effective execution and sustainable compliance.
Laying the Groundwork for Quality and Compliance
Quality by Design means establishing quality and compliance expectations at the design stage rather than relying on downstream correction. For computerized systems, this involves understanding the supported process, identifying critical functions and records, and ensuring design decisions align with both operational intent and quality requirements from the beginning.
This early foundation helps organizations improve implementation outcomes, enhance validation readiness, reduce uncertainty, and avoid compliance gaps that can emerge when systems move forward without clear upstream definition.
Practical Design Support Across Regulated Environments
Design support varies based on the platform, the process it enables, and the regulatory context in which it operates. The examples below illustrate how Anthem applies structured, risk-informed design support across different computerized system environments.
ERP Process Design Support
For an ERP implementation, design support includes defining intended use, mapping impacted business processes, identifying GxP-relevant functionality, and establishing early requirements for user roles, data handling, approvals, system interfaces, and GMP-critical control expectations. This covers status-driven process requirements such as quarantine, release, hold, rejection, segregation, and disposition controls so that materials are handled in line with approved business rules and long-term compliance expectations.
DCS Implementation for a Regulated Manufacturing Shop Floor
For a DCS implementation on a manufacturing shop floor, design support includes understanding the manufacturing process, defining the control strategy, identifying process-critical parameters, and establishing early requirements for control modules, operator interactions, alarm handling, interlocks, system interfaces, and GMP-critical control expectations. This includes defining how the system manages process states, event responses, user actions, and records of operational significance so that manufacturing activities are controlled in line with approved process requirements and long-term compliance expectations.
Network Design in Laboratory Environments
For network design in a laboratory environment, design support includes understanding connectivity requirements across instruments, workstations, servers, and laboratory applications, identifying critical data flow paths, defining interface expectations, and establishing segregation, access, and communication control requirements from a GxP perspective. This covers how laboratory systems connect, exchange significant data, and operate within a controlled network structure that supports reliability, data integrity, and compliance expectations.
Typical Design-Phase Outputs
Poor system outcomes often begin at design
Connect with Anthem to build the right foundation with clear, structured, compliance-focused design support.
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