GxP Technologies
Shihan GX™ — reduce recurring GMP execution errors without replacing your validated systems.
Shihan GX™ is an execution-intelligence layer for GMP manufacturing, QC, development, and scale-up. It identifies which execution choices inside approved SOP or test-method ranges are most connected to successful runs, fewer errors, and better outcomes — and delivers a quantified savings report before broader deployment.
- Up to 75% fewer QC execution errors in a biopharma method
- $4M+ in manufacturing-error savings previously achieved
- 0 systems replaced — sits beside your batch record, MES, LIMS & QMS
Book a 30-minute Error-Cost Diagnostic
Who it is for
QC and assay teams, process development / MSAT, high-cost biologics manufacturing, and CDMOs managing tech transfer, operator variability, and repeatability across sites.
What Shihan GX™ is — and is not
What it is
- An execution-intelligence layer
- Analytics for within-SOP execution choices
- Continuous-improvement support
- Operator mastery transfer across sites and people
What it is not
- Not a replacement for MES, LIMS, or QMS
- Not a batch record or system of record
- Not a compliance or Part 11 system
- Not an uncontrolled AI decision-maker
Where it fits in the GMP stack
- MES / eBR — records and controls batch execution
- QMS — manages deviations, CAPA, change control, approvals
- LIMS — manages lab data and sample workflows
- JMP / analytics — analyzes process and experimental data
- Shihan GX™ — learns which compliant execution behaviors produce better outcomes
Built for continuous improvement inside compliant boundaries
Shihan GX™ works within approved SOP and test-method ranges, does not change the official batch record, and does not replace validated systems. Human review stays in the loop, and the customer controls SOP changes, change control, validation, and QA approval. Its methodology aligns with the FDA's emphasis on process understanding and continued process verification and with ICH Q10's continual-improvement framework. Validation and Part 11 treatment depend on intended use and customer configuration.
Frequently asked questions
Does it replace the batch record or validated systems?
No. Shihan GX™ is not a system of record. It sits beside your MES, LIMS, QMS, eBR, Veeva, and MasterControl as an execution-intelligence layer; your validated systems remain the source of truth.
Is this an AI making GMP decisions?
No. It is a human-reviewed layer that identifies patterns inside approved operating ranges. People decide how insights are used, documented, and governed.
What is the first step?
A 30-minute Error-Cost Diagnostic on one recurring assay, batch, deviation, or retest to size the savings — then a 30–60 day pilot with an executive ROI readout before any broader deployment.
GxP Technologies · Contact support@gxptechnologies.com