Answers to what you'll ask before a demo.

Connect and automate scientific software. Scientists can describe work in their own words, review the steps, run the workflow, and track every action, file, setting, and result.

PixeSci^TM now includes Continuous Quality Monitoring: continuous, deterministic monitoring across your connected systems, a governed AI copilot that recommends but never makes a regulated decision on its own, and a hash-chained, independently verifiable audit trail. See the Continuous Quality Monitoring page for the full picture.

No. PixeSci^TM's agents can read records, flag patterns, and recommend a next step, but they cannot approve, close, release, invalidate, or sign a record, and they cannot write to a connected source system. Those actions require a qualified person on your team, and this boundary is enforced in the software and checked by an automated test suite, not left to a policy document.

A deterministic, versioned set of rules evaluates event data from the systems you connect — instrument runs, audit-trail entries, account activity, and record completeness — continuously. It looks for patterns like unreconciled reruns, records that disagree with each other, missing raw-data references, and activity from shared or ambiguous accounts.

By default, no — inference runs on-device. This is a deployment-configuration question specific to your environment; talk to us about your requirements.

No. PixeSci^TM is designed to run behind the systems you already use — it connects to them, watches for gaps, and carries evidence through the work, rather than replacing them as your system of record. Some customers also choose to run specific modules, like Laboratory or Quality Management, natively in PixeSci^TM — that's a configuration choice, not a requirement.

Not yet as a direct, live connector — those are on our integration roadmap. What's connected today is PixeSci^TM's own native modules, an open-source CDS connector, and a CSV gateway for balance, pH meter, and qPCR instrument data. Tell us your specific stack and we'll tell you exactly where it sits on the roadmap.

No. It's an illustrative tool: one part computes your own routine compliance-tax estimate from inputs you provide, and the other shows two fixed reference scenarios for what FDA-derived remediation can look like, based on PixeSci^TM's own internal modeling. Neither is a prediction for your organization or a guarantee PixeSci^TM prevents these costs — see the calculator's own disclaimer for details.

PixeSci^TM TM also includes laboratory sample tracking, quality management (deviations, CAPA, complaints), materials and products inventory, electronic batch records for manufacturing, equipment qualification and calibration, and document control connected to training records — all running on the same local-first workflow engine.

Yes. Modules connect to the same underlying record and audit system, but you can adopt the ones relevant to your team first and add others later.

No. Workflows run locally by default, close to the software and files your team already controls. Teams can also connect approved internal systems and run workflows on their own servers.

Yes. Teams can run workflows on their own servers or in an air-gapped environment. Workflows do not need a cloud service to run.

Yes. Teams can use approved AI models that run locally or inside their own infrastructure. Available features depend on the models and setup your team approves.

No. Keep those systems as your official records while workflows move approved work between them.

Start with the tools, file types, review points, and outcomes your team needs. Each tool and version must be tested in the environment where it will run.

Yes. Teams can track workflows, records, changes, reviews, and data integrity. Customers still must validate the system, maintain SOPs, train users, and meet their own regulatory duties.

Workflow steps, file movement, user actions, system events, and results can stay with each run. Your setup and policies determine how long records are kept and how teams review them.

Keep steps, files, settings, users, and results linked to each run. Teams can use this history to review, repeat, investigate, and standardize their work.

Track workflow versions, settings, changes, and run history. Each organization must decide how to validate and control those changes.

No. Software alone cannot guarantee compliance. Teams can run controlled workflows and produce records, audit trails, file history, user links, and review history. Compliance still depends on how the customer validates, configures, and operates the system.

No. The catalog shows target software and possible ways to connect it. Teams must confirm readiness for each tool, version, setup, and use case.

PixeSci^TM TM is designed to run behind and alongside your existing LIMS, not replace it. Its own sample-tracking workflow — accessioning, chain of custody, testing, review, and release — is available if you choose to run that module natively in PixeSci^TM, but the platform's core value is connecting to and watching over the systems you already use. Talk to us about your current lab software before deciding what fits your process.

A result that falls out of specification or out of trend opens an investigation and blocks the sample from release until the investigation closes. The investigation is a Quality Management record, tracked the same way as any other deviation or CAPA.

Deviations, nonconformances, out-of-specification and out-of-trend investigations, incidents, CAPA and action items, change control, complaints, audits and findings, supplier qualification and issues, risk management, management review, and regulatory commitments — each as a versioned, auditable record type.

PixeSci^TM TM can generate IQ and OQ reports, a risk assessment, and a requirements traceability matrix for its own deployment, along with Part 11, GMP, and ISO 13485 self-assessments cited against your real audit data. These are a starting point for your own validation work — your organization is still responsible for validating and maintaining the system to its own quality requirements.

Yes. Material lots track parent-child relationships and a full inventory ledger, and product lots can cite the intermediate and material lots used to build them, giving you a traceable path from raw material receipt to a released, CoA-backed product lot.

Yes. PixeSci^TM TM tracks Master Batch Records, line clearance, material dispensing, in-process controls, and QA review and release for each batch, with an e-signature-style reason, printed name, and re-authentication reference captured at each approval step.

A failed in-process control result automatically raises a deviation, which is tracked as a Quality Management record and linked back to the batch.

An out-of-tolerance calibration result automatically moves the asset to in-repair status and opens an investigation in the same action — there's no separate manual step to remember.

Yes. Read-and-understand training is assigned against a specific document revision, and a document marked as requiring training can't be activated until that training is actually delivered and recorded.

Yes — issue numbered copies to named recipients, track acknowledgement status, and recall a copy once it's replaced by a new revision.

PixeSci^TM TM can verify your audit chain, map your controls against a 21 CFR Part 11 checklist, and export audit trails, records, registers, evidence manifests, and bundled inspection packs on demand. These exports support your inspection preparation — they don't replace your own inspection readiness process.