GxP Technologies
Guide your operators toward perfect execution.
Shihan GX™ learns from your own runs which in-range step choices lead to on-spec results, and shows each operator what to change on the next run. It sits beside your validated systems and advises; your people decide.
- Demo data: in our demo SOP, the first 4 runs failed; 7 of the 8 since passed
- 0 systems replaced — sits beside your batch record, MES, LIMS & QMS
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
- Analytics tools — analyze process and experimental data
- Shihan GX™ — learns which execution choices, inside approved ranges, go with on-spec results
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. It is designed to support the process understanding and continual improvement described in FDA process-validation guidance and ICH Q10. 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 and batch record 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?
Request a pilot account and record runs of one of your own SOPs. Each pilot request is reviewed before activation. A 30-minute walkthrough is also available.
GxP Technologies · Contact support@gxptechnologies.com