You retype results between systems that don't talk
Instruments, CDS, LIMS, QMS, spreadsheets. Every retyped reading or calculation is a chance for a transcription error, a pattern that keeps showing up in FDA findings.
Talk to your Lab!™
The autonomous quality control operating system for regulated life sciences.
We help you reduce expensive errors and wasted time operating fragmented, retrospective quality control systems.
You to your lab
Listening
Why was batch-042 reinjected?
CDS
run log
LIMS
batch-042
Audit trail
user activity
Working
0/3 done
- Linked record: Run log, injection 7 / repeated 14:02
- Linked record: LIMS result, batch-042 / assay
- Flagged: Reason for repeat, not documented
Injection 7 was repeated at 14:02. No reason was recorded in the run log or in LIMS.
Flagged for a reviewer
Recommendation only. It cannot approve, close, release, or sign a record.
Problems caught early
Every decision stays yours
Fast deployment
Evidence always in hand
Works with what you already use
Your data stays on your site
The problem
You're stuck in manual and fragmented processes.
Your quality work spans instruments, software, and outside partners that were never built to work together, so the gaps between them land on you.
You lose hours to work nobody should do by hand
Moving data, rebuilding context at every handoff, chasing approvals and checking conditions. It adds up.
You find problems after they've grown
Retrospective review catches an error after it has been repeated, and fixing it costs more than catching it.
You piece together what happened, after the fact
When a reviewer or auditor asks, you start digging through five systems.
What we do about it
We take that off your plate.
PixeSciTM connects your instruments, software, and partners, and runs your routine QC work with your sign-off on every step that matters. Work runs precisely as you approved it, and every action, file, and decision is recorded as it happens. Your team gets complete quality records, an audit trail ready for compliance review, and confidence in every result.
See how it worksWhat's at stake
Small evidence gaps become expensive problems, fast.
Without PixeSci, teams rebuild quality evidence after the fact and find their gaps at release, audit, or inspection, when they cost the most. With it, they carry the evidence through the work and find gaps while they're small.
Teams that don't use PixeSci
Find gaps at release, audit, or inspection
By then, the fix is an investigation.
Lose weeks to rework and batch holds
Every disconnected record becomes a reconstruction project.
Watch a small team drown in reconciliation
Your best people spend their days moving data between systems.
Put timelines and revenue at risk
Delayed release and slower market access follow.
Teams that use PixeSci
Catch problems while they're small
Exceptions reach the right person as they happen.
Release and review on schedule
The evidence is already there when the reviewer asks.
Walk into audits with the record connected
Every run, record, and exception is already linked.
Do more with the team you have
PixeSci does the watching and the connecting. You make the decisions.
What winning looks like
Your quality team gets to do the actual quality work again.
Ask your lab what's happening
Talk to your lab in plain language and get an answer, instead of pulling data from five systems.
Problems surface while they're small
You hear about an exception when it happens, not at release or inspection.
The evidence is already connected
When someone asks what happened, every record, run, and exception is already linked.
Your team decides, every time
PixeSciTM does the watching and the connecting. Every approval, closure, release, and signature stays with a qualified person.
How we get you there
Four things stand in your way. We clear each one.
The obstacle
Evidence gets rebuilt after the fact.
Quality Core
One connected record, so the answer is already there when someone asks.
The obstacle
Your systems don't talk to each other.
Integrations
We connect them, so your team stops being the glue.
The obstacle
Someone has to connect it all by hand.
Agentic Automation
Routine QC work runs for you, with your sign-off.
The obstacle
Problems surface late.
Continuous Quality Monitoring
We watch around the clock and flag early.
You stay in charge
PixeSciTM works for you. You make every decision.
PixeSciTM reads, watches, and recommends. It can't approve, close, release, invalidate, or sign a record, and that limit is built into the software, not left to a policy document.
You set what PixeSciTM can do
Every capability is scoped to one job: reading, flagging, or drafting a recommendation. Never an open-ended mandate.
Bigger actions need your approval
The riskier the action, the more approval it needs before it runs.
No regulated decision without you
PixeSciTM never approves, closes, releases, invalidates, or signs a record on its own. That limit is enforced in the software, not just written in a policy.
Answers you can check
Every recommendation points to the records and results behind it, and PixeSciTM declines to guess when evidence is missing or conflicting.
Nothing happens off the record
Every action PixeSciTM takes lands in the same verifiable audit trail as your team's, and you can check that trail any time.
Stays on your site
PixeSciTM and its AI run on your own hardware by default. No cloud service required.
Aligned to FDA and EMA good-AI-practice principles: clear intended use, proportionate risk management, trustworthy data, independent validation, human oversight, defined accountability, controlled change management, and auditable records.
See how you stay in controlSound familiar?
Recognize any of these?
These are common patterns across regulated labs, described as categories, not as citations to any specific company or inspection. We watch for them continuously, so you can find and fix them early.
Raw data, blank on paper, complete in the summary
A worksheet or batch record has blank fields, but the summary report shows a complete, passing result.
An instrument's own history disagrees with the record
The chromatography or instrument audit trail shows aborts, reinjections, or method changes that the paper record doesn't mention.
A repeat test with no stated reason
A test is repeated, and only the passing result is reported, with no documented justification for the repeat.
A deviation closed without root cause
An out-of-specification result or deviation is closed with a corrective action but no investigation into why it happened.
These categories are illustrative and general to the industry. They do not describe any named company, product, or specific regulatory action.