Formulation, API and packaging
Pharmaceutical manufacturing
In pharmaceutical manufacturing the data is part of the product. Records must be attributable, legible, contemporaneous, original and accurate — which changes how every system is designed, from the audit trail up. We work to that standard rather than adding it afterwards.
What goes wrong
Typical problems in pharmaceutical
If more than two of these are familiar, there is a first project here worth doing.
- 01
Environmental monitoring recorded manually on rounds
- 02
Batch records assembled from several systems and paper
- 03
Audit trail requirements not met by existing tools
- 04
Deviations identified during review rather than as they occur
- 05
Validated systems make change slow, so improvements are deferred indefinitely
What we build
Solutions for pharmaceutical
- 01
Continuous environmental monitoring
Temperature, humidity, differential pressure and particle counts logged continuously with alarms, escalation and a complete audit trail.
- 02
Electronic batch records
Process parameters, equipment, materials, operators and results captured against the batch as it runs, with electronic signature support.
- 03
Data integrity by design
Immutable audit logging, role-based access, time synchronisation and controlled change — designed in from the start because retrofitting it is far harder.
- 04
Equipment and utility monitoring
Autoclaves, HVAC, purified water and compressed air monitored continuously with excursion alerting.
- 05
Validation support
Documentation, test protocols and traceability matrices prepared to support your qualification and validation activities.
Technology
What is typically involved
- Calibrated sensors with documented traceability
- SCADA platforms with audit trail and signature support
- Time-synchronised logging across all systems
- Role-based access with segregation of duties
- Immutable, queryable audit storage
- Structured documentation for IQ/OQ/PQ support
Outcomes
What changes
Described rather than quantified — we do not publish numbers we have not measured for you.
- Environmental excursions detected as they happen, not at review
- Batch record assembly time substantially reduced
- Audit trail available to inspection without preparation
- Utility performance monitored continuously
- Change managed within a controlled, documented process
Capabilities
Most relevant here
- SCADA DevelopmentSCADA design, implementation, migration and integration.
- Machine MonitoringReal-time machine, production and downtime monitoring with OEE.
- Custom Industrial SoftwareWeb applications, backends and APIs built for plant operations.
- System IntegrationConnecting plant systems to ERP, MES and the rest of the business.
- Industrial IoTGet data off your machines — existing PLCs, new sensors, or both.
Questions
Pharmaceutical — common questions
Do you provide validated systems?
We design and build systems to support validation, and we prepare the documentation, test protocols and traceability that qualification requires. Validation itself is executed and approved by your quality function — that is how it should work, and any vendor claiming to hand you a pre-validated system is describing something different from what your regulator means.
How do you handle 21 CFR Part 11 and Annex 11 expectations?
Through the technical controls those expectations require: unique user identity, role-based access, secure electronic signature where applicable, immutable and reviewable audit trails, time synchronisation, and controlled change management. We map each control to the requirement in the design documentation so your quality team can review it directly.
Tell us about your pharmaceutical plant
What runs on your floor, and what you cannot currently answer. We will tell you what is readable today and what a first phase would involve.