// IT consulting & service engineering · GMP
IT systems built
for GMP.
Consulting and service engineering for regulated manufacturers. We design and run infrastructure and applications with ALCOA+ data integrity as a design criterion — not as a check performed at the end.
Regulatory frameworks we work to
- ALCOA+data integrity
- Annex 11EU GMP
- Part 1121 CFR
- PIC/S PI 041data management
- GAMP 52nd edition
- GDPRpersonal data
01 — the problem
Data integrity is decided when the system is designed
An audit trail nobody reviews, shared logins on a shop-floor terminal, raw data sitting on a local drive with no backup: these are the findings that end up in inspection reports. None of them originates in a validation error.
They originate in choices made years earlier, when the system was selected, configured and connected without anyone asking how it would look to an inspector. Validation comes afterwards, and it cannot repair an architecture that leaves data fragile.
We get involved earlier: in technology decisions, infrastructure and day-to-day operations, using the nine ALCOA+ attributes as a design criterion.
02 — ALCOA+
Nine attributes, every technical decision
Not a checklist to fill in at the end of a project. It is how we assess a vendor, size a backup or decide on an access profile.
Attributable
You always know who did what. No shared accounts.
Legible
Readable today and in ten years, file formats included.
Contemporaneous
Recorded as it happens, with synchronised clocks.
Original
Raw data is retained, not just the printout.
Accurate
Controls prevent the error at the point of entry.
Complete
Including repeats and discarded attempts.
Consistent
Sequence and timestamps aligned across systems.
Enduring
Media and backups that survive the retention period.
Available
Retrievable within useful time during an inspection.
- Read more
03 — services
What we bring
Every service has a defined deliverable and a named owner. No generic advice: you end up with documents that hold in an audit.
| Service | Deliverables | References |
|---|---|---|
| IT consulting for GMP | System assessment · gap analysis · prioritised roadmap · vendor selection support | Annex 11 · ALCOA+ |
| Calibration & instrument qualification | Installation & commissioning · IQ/OQ/PQ qualification · calibration with metrological traceability · preventive maintenance | USP <1058> · ISO/IEC 17025 |
| Data integrity | ALCOA+ gap assessment · audit trail review · remediation plan · periodic review | ALCOA+ · PIC/S PI 041 · Part 11 |
| Infrastructure and data security | Design spec · qualification package · backup & DR with restore testing · access control | Annex 11 · GDPR |
| Application management | ERP/LIMS/MES/QMS support · incident & change management · SLA reporting | ITIL 4 · Annex 11 |
| Computer system validation | URS · FS/DS · IQ/OQ/PQ · traceability matrix · validation summary report | GAMP 5 · Annex 11 |
04 — industries
Where we work
On the systems that generate and hold quality and production data, and on the infrastructure that keeps them running.
Explore industries// quality systems
QMS, document control, deviations & CAPA, training records
// laboratory
LIMS, ELN, analytical instruments, integration and audit trail review
// manufacturing
MES, electronic batch records, SCADA, OT-IT integration
// business systems
ERP, WMS, serialisation and supply chain traceability
// infrastructure
Virtualisation, backup, disaster recovery, network segregation
// cloud
Qualified environments, supplier assessment, continuous monitoring
Start with an assessment
Tell us about the systems, the regulatory context and the deadlines. We reply within two working days with an initial feasibility view, at no cost.
or info@datarei.it