One twin engine, one capability record, one validation package, one security posture. This is the part your IT, quality and security teams will ask about, answered in the detail they need.
The difference between a generic simulation and one that qualifies an operator is that the second is built to the make and model of the equipment that operator will actually touch. That depth is normally bought at the price of time: a bespoke build per machine, quoted in months, priced as a project.
The twin engine exists to remove that trade-off. Authoring is a pipeline with defined inputs, defined stages and a defined output, which is why depth and speed stop being opposites.
Because the model is built once and bound to steps rather than baked into a video, the same asset serves simulation, guided execution and, where relevant, robot training. It is authored OpenUSD-compatible so it can be consumed by Isaac Sim and Cosmos without being rebuilt.
More than 150 GMP simulations built to this pipeline, across parenteral and oral solid dosage operations.
Typical machine-specific twin authored in 6–10 weeks, subject to SOP maturity and drawing availability.
Most plants can tell you who attended a training session. Very few can tell you whether that person can perform the task, which step they fail on, or whether the capability they demonstrated eight months ago still holds. The records exist, but they sit in separate systems and none of them was built to answer a capability question.
The capability data layer is the part of 8chili that makes this an operating system rather than a set of applications. Every interaction across the platform, whether a simulation attempt, a spoken inspection answer, an executed work instruction or a troubleshooting query, resolves to one person, one role, one line, one record.
Why this is not reproducible by a stack of tools: Telemetry of this kind can only be generated by a system that watches the work being performed against a known-correct model. A learning system records attendance because attendance is all it can observe.
Artificial intelligence in a GxP environment is a validation problem before it is a capability problem. The question is not what the model can do; it is what it is prevented from doing, and whether that prevention can be demonstrated.
Where 8chili answers a question about a controlled document, the answer comes only from your approved document set. Nothing from the open internet, nothing from another customer, nothing from model memory.
Retrieval runs first. If retrieval returns nothing relevant, the language model is never invoked and the system states that the answer is not in the approved documents. The refusal is a design control in the retrieval layer, not an instruction to the model.
Every answer carries the document, section and page it came from, so a person verifies against the controlled document in seconds. The system points at the source; it does not replace it.
Conversational interactions run inside an authored scenario frame. The model does not free-run outside it. Every interaction is logged and reviewable.
Superseded revisions are excluded from the index and cannot surface. Re-indexing on document revision is part of the operating model, with a defined trigger and a named owner agreed at deployment.
No 8chili system approves a document, releases a batch, closes a deviation or qualifies a person. It produces evidence and answers; your procedures and your people make the decisions.
This risk-based, design-controlled approach is consistent with the direction of the FDA's 2025 framework on AI credibility in regulatory decision-making and the draft EU GMP Annex 22.
8chili ships a computerised system validation package with every deployment, following GAMP 5 and a V-model methodology. It is written to be read by a quality reviewer rather than by a procurement portal.
8chili supplies the package, the protocols and the evidence of system behaviour. Validation itself is site-specific and remains yours: your quality unit executes and approves the qualification for your environment, your equipment and your procedures. The package exists so that execution is a review rather than a build.
Tamper-Evident Session Records: Electronic records are attributable, legible, contemporaneous, original and accurate, with tamper-evident audit trails and electronic signature support aligned to 21 CFR Part 11.
Request the Validation SummaryCertified Information Security Management System
Certified Security, Availability & Integrity Auditing
For your security review: Certification reports, architecture documentation and completed security questionnaires are available under NDA.
Stated plainly, because it is the question behind most of the others.
Your SOPs, your authored content, your operator records and your execution evidence belong to you, without qualification. Termination does not change that; export is contractual.
Where 8chili answers questions from your approved documents, those documents remain in your infrastructure. The 8chili layer manages access and usage; it does not hold your document content.
Where the platform captures evidence of work being performed, what is captured, at which steps, and for how long it is retained are your configuration decisions, disclosed to your workforce.
Any use of anonymised aggregate interaction data to improve platform models is explicit, contractual and agreed in advance. It is never assumed, and it is never a default.
Hosted by 8chili on AWS multi-tenant cloud infrastructure with isolated customer data partitions and regional residency options (including AWS ap-south-1). High availability, continuous security monitoring, and zero infrastructure overhead.
8chili does not ask you to replace a system you have already validated. It integrates at the layer where workforce capability is created and recorded, and it exports into the systems that already hold your records.
8chili Core is engineered with open, standard integration protocols. We seamlessly connect to your existing LMS, QMS, LRS, or MES as your deployment requirements dictate—with zero legacy vendor lock-in.
Third-party names are the trademarks of their respective owners. Their appearance indicates interoperability and not partnership or endorsement.
Multi-tenant cloud platform hosted on AWS with regional data residency options (including AWS ap-south-1). Fastest to start, fully managed, and zero customer IT hardware footprint required.
Standalone VR headsets, with no PC tether and no dedicated room. AR smart glasses specified for use in Grade A and B environments. Tablets, smartphones and shop-floor terminals. Device management and deployment guidance is included in implementation.
A platform that claims to do everything is a platform that will be evaluated against everything. 8chili occupies one layer and integrates with the rest.
Manufacturing execution is a validated system you already own. 8chili sits above it in the workforce execution layer. No rip and replace, no platform war, and a much shorter path to a pilot.
Your controlled documents stay in your DMS under your change control. 8chili reads the approved set; it does not author, revise or approve content.
Your training record stays where it is. 8chili supplies better evidence to put in it.
No 8chili system releases a batch, closes a deviation, approves a document or qualifies a person. It produces the evidence; your procedures and your people decide.
A technical review with your IT, quality and security teams: architecture, validation package, security posture, integration scope.