What we do
Six fronts covering the lifecycle of systems, infrastructure, processes and data in GxP environments.
Computerized System Validation
From validation plan to final report, with a risk-based approach and CSA.
IT & OT Infrastructure Qualification
Servers, networks, cloud, SCADA and PLCs qualified on a "qualify once, deploy many" model.
Commissioning, Qualification & Validation
Qualification of production equipment and processes with DQ, IQ, OQ and PQ, integrated with commissioning.
Data Integrity
ALCOA+ gap assessment, remediation and audit-trail governance across the GxP lifecycle.
GMP Audits & Compliance
Internal and supplier audits and mock inspections to arrive ready for inspections.
Training
Hands-on training in GAMP 5, CSV, Data Integrity and GMP, in-company or remote.
Artificial Intelligence Governance
Inventory, usage policy and output traceability for AI in GxP processes.
Three technologies that change the cost and timeline of validation
Traditional consultancies scale by hiring people. We scale with technology — and keep the regulatory decision where it belongs: with a qualified reviewer.
Assisted documentation, not automatic
AI drafts URS, risk assessments, specifications, protocols and reports from a single knowledge base. Every output records tool, version, input, reviewer and approval — the control the draft EU GMP Annex 22 will require.
Evidence capture without typing
Robots walk the system screens, capture configuration, audit trail and access profiles, and assemble the paginated dossier. What used to take weeks of manual screenshots now runs on its own, with the path itself recorded.
Review by exception, not by sampling
The full audit trail analysed for anomalies instead of a sample. Validated-state indicators, deviation detection and risk prioritisation driven by data rather than impression.
None of this replaces regulatory judgement. It replaces the repetitive work that consumes the time of the people who should be exercising it.
The validation lifecycle, automated where it can be and reviewed where it must be
AI drafts and traces. The qualified reviewer decides and signs. No critical step leaves human hands — that is how the schedule gain survives an inspection.
System technical documentation, key-user interviews, screens and release notes.
Every node records tool, version, input, reviewer and approval. It is the same control the draft EU GMP Annex 22 will expect of your operation.
What changes in your case
A parametric model with open assumptions. Move the controls and see the effect on documentation effort. Not a quote and not measured client data — it is the model we use to size scope.
- AI cuts drafting by 70%. Qualified review and test execution are not reduced.
- Specification documents are 75% drafting. IQ/OQ/PQ protocols are 35% drafting and 65% execution.
- Assumed capacity: 30 productive hours per week per senior consultant.
- GAMP category multiplies base effort: C3 ×1.0 · C4 ×1.6 · C5 ×2.4.
Illustrative figures derived from the assumptions above. Real scope is sized in the assessment.
The V-cycle, no loose ends
Every specification on the left has a mirrored verification on the right, linked by a living traceability matrix — from URS to validation report.
Risk-based
Effort proportional to GxP impact. No excess documentation where risk does not justify it.
Traceable
From URS to report, each evidence points to a requirement. Nothing loose, nothing orphaned.
Defensible
Dossiers structured to withstand ANVISA, FDA and EMA inspections with no improvisation.
Let's talk about your validation project
Initial assessment with no commitment. Reply within 1 business day.
Video call, no commitment.