Industry
Control systems for pharmaceutical plants
In a regulated plant the control system is not judged only on whether it works. It is judged on whether you can demonstrate that it works, to somebody who was not there.
We work the utility and facility side of pharmaceutical manufacturing — the systems that hold the environment steady rather than the ones that touch product. Cleanroom pressure cascades, HVAC, purified water generation and distribution, extraction and scrubbers.
The engineering is not fundamentally different from any other plant. The documentation is. Qualification evidence has to be produced as the work happens; reconstructing it afterwards is expensive, and an assessor can usually tell.
How a qualified job differs
- Step 01
Categorise first
A GAMP category assessment sets the documentation burden. Treating a category 3 system as category 5 wastes money; the reverse causes an audit finding.
- Step 02
Specification trail
URS, FDS and design specification with a traceability matrix from requirement to test.
- Step 03
Test as evidence
FAT and SAT records written as qualification protocols, executed and signed rather than reconstructed later.
- Step 04
Change control
Every post-qualification change assessed, documented and re-tested to the extent the assessment requires.
Being straight about scope
We are a controls engineering firm, not a validation consultancy. We produce the engineering documentation and execute the protocols; where a job needs a formal validation lead or a QA sign-off function, that sits with your quality team or a specialist, and we will say so at quotation rather than after.
Questions we get asked
Next step
Running pharmaceutical plant?
Tell us which system, which platform, and what the constraint is. We will tell you honestly whether we are the right firm for it.
An engineer responds within one business day.