Ireland / Pharma / biotech process systems
Project definition
A sample utility/process skid package centred on instrumentation traceability, FAT documentation and an interface register.
Illustrative subcontract scope
- Instrument and signal register
- FAT test-case matrix and traceability
- PLC/vendor interface list
- Deviation and open-point register
Client inputs
- URS / functional specification
- P&IDs and instrument datasheets
- Approved acceptance criteria
- Test responsibility matrix
Standards to check — not conformity claims
- I.S. 10101:2020+A1:2024/AC2:2025 (installations)
- IEC 61511 (if applicable to SIS)
- Client GxP / validation procedures
Applicability note: Electrical installation rules, functional safety and regulated validation have different scopes; no GxP-compliant deliverable is claimed by this demo.
Miniature technical register
Representative synthetic data rows showing desired document structure, not finished engineering drawings.
| Tag / ID | Signal / Item | Description | Remark |
|---|---|---|---|
| FAT-001 | DI input simulation | Pending | Reference FDS-1 |
| FAT-002 | Analog high alarm | Pending | Reference FDS-3 |
| FAT-003 | Power failure indication | Pending | Reference FDS-5 |