Purified water and clean utilities that hold up under inspection.
A regulated site is judged on its record as much as its equipment. ASE engineers purified water, clean utilities, and GAMP-aligned automation as one qualified package, with the validation pack written as the system is built rather than reconstructed for the audit. This is the practice’s founding discipline, running since 2003.
Standards we work to
- USP <1231>
- EP 0169
- GAMP 5
- ICH Q9
- WHO GMP
Six systems an inspector will open.
Each programme carries the documentation a regulator would accept. The operator, the auditor, and the partner read from the same record.
Purified + WFI water
Generation, storage, and distribution loops engineered to USP and EP specification. Hot-loop sanitisation, full validation packs, and qualification support.
Clean-utility generation
Clean steam, compressed air, and process gases specified against the actual point-of-use demand, not the vendor package.
GAMP-aligned automation
PLC, SCADA, and historian systems delivered with control narrative, role matrix, and audit trail acceptable to regulators.
Facility continuity
Redundancy engineering for HVAC, electrical, and critical utilities. Written impact analysis before any single-point-of-failure is accepted.
CSV + validation lifecycle
IQ, OQ, and PQ delivery, periodic review, and change control run by the engineers who designed the system, not subcontracted to a third party.
Remediation + inspection response
CAPA engineering response for regulator findings. Written plan, named owner, and evidenced close-out inside the client’s deadline.
Work of this kind
The full record
Delivered 2025Early product scoping
Early product and MVP scoping support for ChemCapital, an AI-driven procurement platform for process-equipment sourcing across pharma, chemical and industrial manufacturing.
OngoingData and programme delivery
Data and delivery workstream inside the Austrian dairy group’s enterprise-systems and analytics programme, coordinating the external delivery partners across the SAP landscape. Reference on request.
Survey. Design. Build + qualify. Steward.
The discipline that regulators expect inside the facility applies to the delivery record outside it. One partner signs across all four stages.
- Listen
Survey
Site walk, utility demand modelling, and URS review. A written baseline of the facility before any specification is drafted.
1 – 2 weeks
- Write
Design
P&IDs, equipment selection, and validation strategy issued as a stamped package. Independent of any single equipment vendor.
3 – 6 weeks
- Deliver
Build + qualify
Installation, FAT, SAT, sanitisation, and IQ/OQ delivery under the name of the partner who signed the scope.
12 – 24 weeks
- Hold
Stewardship
Periodic review, change control, and planned replacements by the engineers who designed the system.
Retained
Know what your utilities show under inspection.
Thirty minutes with a senior partner. You leave with a written summary of the utilities, the qualification burden, and a direct line back.