Pharmaceutical.
Every change leaves evidence
In a regulated plant, a system change is a quality event. ERP, quality, laboratory and warehouse systems carry batch and release data that an inspector can ask about years later, and the audit trail has to show who changed what, when, and why it was allowed.
Validated systems kept in their validated state, and change records an inspector can read without a guide.
Impact, testing, approval and rollback recorded for every change, as the work happens.
Audit trails, access and retention treated as controls, not as settings.
E-Business Suite, Fusion and the database layer beneath them, supported by the same team.
Manufacturing ERP and quality data support is long-standing work for us.
The three that come up every time
Not an exhaustive list. These are the ones that show up in the first conversation on almost every pharmaceutical engagement, and the ones the service is shaped around.
Validation that decays after go-live
Systems are validated at implementation and then patched, configured and integrated for years. Each change that skips the impact assessment erodes the validated state.
Every change is assessed for GxP impact, tested to a risk-based level and documented before release, with your quality unit approving.
A validated state you can demonstrate on any given day.
Audit trails nobody reviews
Data integrity findings rarely come from missing audit trails. They come from audit trails that exist and are never looked at, and shared or generic accounts.
Access is named, reviewed on a cycle, and audit trail review is built into the operating calendar.
Integrity evidenced, not assumed.
Batch, quality and supply data in different places
ERP, QMS, LIMS, MES and serialisation platforms each hold part of the batch story, joined by interfaces that are often undocumented.
Interfaces are inventoried, monitored and brought under change control alongside the systems they connect.
A batch record that agrees with itself.
The parts of the service that do the work
Nothing here is specific to this sector. These are the same families described across the site, scoped to what a pharmaceutical estate actually needs.
Managed IT Services
Infrastructure, network and end-user support with change control and access review run to a regulated standard.
Oracle Services
E-Business Suite and Fusion for process manufacturing, quality and supply chain, with in-house Oracle expertise.
Application Management
Integrations between ERP, QMS, LIMS and serialisation platforms, with documented testing for every release.
AI Solutions
Document and deviation triage, search across quality records, with a human approving every regulated decision.
Shaped to the sector, not relabelled for it
The delivery model is the same one described on the service pages: one accountable team, one ticket queue, a monthly service review. What changes for this sector is where the attention goes and how the work is scheduled.
Everything below is a working practice rather than a promise. If one of them would not survive contact with your estate, say so in the first call and we will tell you what it would take.
Talk to an expert- Your quality system, not oursWe work inside your SOPs, change control and CAPA processes. Where a document needs a quality signature, it gets one before the change, not after.
- Risk-based testingTest depth follows GxP impact. Non-GxP changes are not buried in paperwork, and GxP changes are not waved through on a standard ticket.
- Inspection-ready recordsChange records, test evidence, access reviews and incident reports are filed as the work happens, so an inspection request is a retrieval, not a project.
Scope and targets are set after discovery, against the estate as it stands.
Before you send an RFP
Do you validate systems for us?
We execute and document validation work within your framework: impact assessments, test scripts, execution evidence and traceability. Your quality unit owns the validation approach and approves the outcome. We do not certify compliance, and nobody outside your organisation can.
Can you support a system that is GxP relevant without breaking its validated state?
Yes. That is the point of running change control as the working method rather than as an extra step. Patches, configuration changes and integration work are assessed, tested and documented before release, with your approval.
Do you work on laboratory and shop-floor systems?
We support the IT estate and the integrations between systems. Instrument-level software, process control and equipment qualification stay with the vendors and teams who qualify them, and we hold the interface between the two.
Can AI be used in a regulated environment?
Yes, for the right tasks and with controls. Search, summarisation and triage of documents can save real time. Decisions that affect product quality or patient safety stay with qualified people, and any AI-assisted step is documented like any other system function.
Send us thevalidation pack.
Or what is left of it. The first call is a scoping conversation about where the estate stands, and the discovery output is yours either way.