Automation / Quality
PLC / HMI / SCADA design & verification
Specifying and verifying the control system of a new filling machine before GMP use.
Illustrative use caseIllustrative use case
Pharmaceutical lifecycle digitalisation roadmap
A phased roadmap connecting laboratory, manufacturing and quality systems, with AI where it fits.
Challenge
Separate system projects overlapped and data could not flow between them.
Requirement
An integrated roadmap with priorities, interfaces and validation strategy.
Approach
Assess current systems and pain points, define target architecture, prioritise by value and risk.
Process & execution
- 1Current-state assessment
- 2Target architecture
- 3Prioritisation
- 4Roadmap
- 5Governance
Technology / process
- ISA-95
- Integration architecture
- Validation strategy
Documentation
- Assessment report
- Architecture
- Roadmap
- Governance charter
Verification
Roadmap reviewed and approved by business and quality leadership.
Outcome / expected benefit
Expected benefit: systems that connect, investments in the right order.
This is an illustrative use case describing a typical project structure. It does not describe a specific client, product or completed engagement.
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Designing the move from paper batch records to electronic execution with review by exception.
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Pharmaceutical document management system
A controlled document lifecycle with review, approval, effective dates and archive.
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