Services
We help regulated laboratories and manufacturing sites find their data integrity gaps, close them, and keep them closed, whether the answer is configuration, process, validation or new software.
How our services fit together
We expect most engagements to follow the same path. The assessment shows where the gaps are, remediation and new software close them, and controlled change keeps systems compliant as they evolve. Consulting support is available at every stage.
The starting point: Data Integrity Assessment
A fixed-scope review of your systems, data flows and procedures, built on a method our founders developed and relied on in a regulated laboratory. You receive a risk-ranked gap register, a prioritized remediation roadmap and an executive summary, with no obligation to engage us for what follows.
Our services
Bring aging instruments and workstations up to current expectations without a forced replacement: data capture at the source, attribution, record preservation, virtualization of unsupported systems, and the procedures that make the controls stick.
Strengthen the processes around your data: review practices that go beyond the result, batch records and logbooks done right the first time, controlled hybrid records, training that builds competence, and metrics that show where integrity is at risk.
Work where Quality and IT meet: risk-based validation strategy, Part 11 and Annex 11 readiness, new labs and systems, modern infrastructure in GxP environments, and audit and inspection support.
When the right fix is new software, we build it with audit trails, electronic signatures, role-based access and validation support designed in from the first requirement, and manage its full change-controlled lifecycle.
Where to start
If you know the problem but not which service it falls under, this is a good place to begin.
| If you’re facing this | Start here |
|---|---|
| An inspection is approaching, or you’ve received data integrity observations or audit findings. | Data Integrity Assessment |
| Older instruments with shared logins, thermal printouts, local data storage or unsupported operating systems. | Legacy system remediation |
| Recurring batch record corrections, review that doesn’t cover audit trails, or paper and electronic records that don’t reconcile. | QC & manufacturing data integrity |
| A new laboratory, a new system to select or validate, or a validation approach that has become a backlog. | GxP technology consulting |
| A process no commercial product fits, systems that don’t talk to each other, or a spreadsheet that has become a system of record. | Custom compliant applications |
| A validated system that needs a new version, feature enhancements or fixes under change control. | Our approach to the validated lifecycle |
Not sure where you fit?
Tell us what’s going on. A short conversation is usually enough to point you to the right starting place, even if it isn’t us.