You answer for every value. Even the ones you outsource.
APR, CPV, comparability, and every filing and inspection response rest on as-executed data produced across CDMOs you don't run. Trell links every value in the records you hold back to its source, reviewed before you stand behind it.
You hold the filing. The records sit at sites you may not control.
The obligation is yours. The batch records, CoAs, and stability data that prove your process sit across CDMOs and labs you may not run. Trell closes the sponsor-CDMO evidence gap, on both sides.
The as-executed data to assess state of control across every CDMO, without touching their systems.
APRs, IND annual reports, and comparability data, linked to source and ready to trend and defend. When the executed record sits only at the site, Trell works from the package the CDMO already provides. If your evidence lives at CDMOs and contract labs, it is in scope from your first development run through commercial.
Give every sponsor release-ready data, and make your quality data your competitive edge.
Trended, source-linked evidence assembled on top of what you already run, with no rip-out and no migration. You surface and close traceability gaps on your own terms, before any client audit, so your programs present clean and your renewals are easier to defend. Nothing is written back.
The obligation doesn't move. The evidence is already there.
Annual Product Reviews, built to be audit-ready when they're due.
The APR is required and the clock is annual. Every batch, CoA, and stability result stays review-ready across all your CDMOs, so the report is assembled and defensible when it's owed.
Your IND and first filings, on evidence instead of rebuilt spreadsheets.
The CMC section of your IND rests on development runs, tox batches, and engineering batches, plus analytical history scattered across the CDMOs and labs that generated them. Trell links development and GMP data alike back to source, so comparability across process versions and your first filing sit on source-linked evidence from day one.
Continued process verification, and release you can defend.
Disposition can't wait on scattered data, and the process must stay in a demonstrated state of control to keep releasing. As-executed values stay trended and traceable. Your qualified reviewer still makes every call.
Inspection-ready, and comparability that survives review.
When an investigator asks for the source of a value, it is there, attributable and traced. A result recorded against a superseded method is surfaced for qualified review, with the source shown, so your team catches it before it moves downstream. Comparability packages arrive complete and source-linked, so review turns on the science, not on missing traceability.
Tech transfer and investigations, on evidence you can defend.
When a transfer or an investigation turns on what actually happened, the executed record is already assembled and source-linked. Intended, planned, and executed line up before a handoff or a deviation becomes a delay.
Analytical results and stability, traced to method and source.
Every CoA value, stability point, and release result ties back to its source record, so QC can defend each number and catch an OOS or a superseded-method result before it moves downstream.
In one deployment, evidence assembly on a representative release package fell from an SME-estimated 80 hours to under 4, measured on the sponsor's own records, with every value linked to source for qualified review.
Not another system. The as-executed layer that ties every value to its source.
Trell reads the scattered, as-executed records you already own, batch records, CoAs, and stability data, paper and PDF included, and turns them into one source-linked record a qualified reviewer confirms before use. From there the same record drives APR, CPV, comparability, and inspection response. Read-only over your systems, writing nothing back, every step logged. Your MES, QMS, and other systems each hold part of the truth. Trell is the layer that reads the executed record across the CDMOs and testing labs you outsource to and stands behind every value with its source.
What design and knowledge platforms do.
They author the plan, the control strategy, the specs, what the process should do. Trell captures what it actually did, and makes it defensible.
What execution and analytics systems need.
They assume the data is already clean and in one place. Trell reads it where it actually lives, in the executed record across systems you don't control.
An operator who answered for this data.
Trell didn't come from a software team first. It was built by Tyler Gadoury, founder and CEO, formerly Head of Process Development and MS&T at Catalent, with 15 years across CMC at BMS, Alexion, and Catalent. He answered for exactly this data and rebuilt the same evidence by hand before every release, filing, and inspection. Quality and validation experts work alongside. That experience is the product: the traceable, defensible answer, already assembled, sitting where the filing or the inspection needs it.
Built for sensitive GMP records, and for the people who answer for them.
Trell is designed for teams working with batch records, CDMO packages, QC outputs, process documents, deviations, and other sensitive GMP materials. It reads what you already own, read-only, and writes nothing back. AI drafts the trace. A qualified reviewer on your team confirms each finding against its source, and a second reviewer verifies it. The platform queues, tracks, and enforces that two-step check on its own, including making sure no one verifies their own confirmation, so the rigor comes from the system, not from added process for your team. Trell supports the decision. It never makes it.
Runs alongside your validated systems.
From day one, Trell operates as a decision-support layer beside your systems of record. It reads records read-only and writes nothing back. Because it does not run or control manufacturing and is not itself a system of record, your MES, QMS, and LIMS stay the systems of record, and your qualified reviewer makes every release, filing, and investigation call. We can walk through how Trell fits your CSA (computer software assurance) and validation approach during evaluation, under NDA.
21 CFR Part 11 controls when your use case calls for it.
When you need Trell inside a GxP-controlled workflow, Validation Mode is available as a client-elected, separately scoped engagement. It is qualified through your validation lifecycle (IQ/OQ/PQ) under a Quality Agreement, with 21 CFR Part 11 controls, audit trail, access control, and electronic-record integrity established as part of that qualification. It is not enabled by default, so most teams start in Support Mode and move only if and when they need to.
Each finding links to the exact record, page, and field it came from, so a reviewer confirms the AI-proposed value against the original before accepting it. A second reviewer verifies what the first confirmed, and the system enforces that separation automatically. Nothing enters a decision unread.
Where a source is ambiguous or hard to read, Trell flags the value for mandatory human review rather than asserting it, and records the AI-proposed value alongside the value the reviewer accepts.
Extraction accuracy is measured against the source records on a representative sample at the start of each engagement and reported to you, so you see the numbers on your own data before you rely on them.
Data is encrypted in transit using TLS and encrypted at rest. Records and findings are not transmitted or stored in plain text.
Access to records, findings, and reports is controlled by role. Internal access to customer data is limited to what is required to deliver and support the service.
Trell reads the records you already own and writes nothing back to your systems. Every step is logged.
Access and activity within Trell is logged in every mode; formal 21 CFR Part 11 audit-trail controls are part of Validation Mode. Logs support customer audit and inspection needs.
Each customer runs in its own isolated environment with a dedicated database and compute. No other customer's records or findings are reachable from it, at the connection layer, not just by policy.
A CDMO's programs run inside that customer's single, dedicated environment; within it, each sponsor and program is further segregated by role, so teams reach only the records and findings they are entitled to.
Trell runs on Amazon Web Services in a US region, with KMS encryption, VPC and IAM isolation. Customer data is hosted and stored only in US regions; no customer data is stored outside the US without prior written notice, and any remote support access by authorized personnel is limited.
Your data is never used to train any model, ours or a third party's, without your prior written consent, which you can withhold or withdraw at any time; no such consent is in place today. Retention follows defined schedules meeting regulatory minimums; your data is returned or deleted within 30 days on request or at termination, subject to those minimums and legal hold.
Lumetica maintains a current sub-processor list, available to customers on request under NDA, and gives at least 30 days' advance written notice before adding or replacing a key sub-processor. Customers may object on reasonable security or privacy grounds.
MFA is enforced for cloud infrastructure access, on top of role-based, least-privilege access.
Business continuity and disaster recovery are maintained with defined RTO and RPO targets, restore-tested before each production go-live and at least annually thereafter.
Under the Data Processing Agreement, Lumetica notifies you within 24 hours of becoming aware of a data breach, and assists with data-subject requests and deletion or return on termination.
Trell supports customer security review and vendor assessment, and can provide security and QMS documentation, available under NDA, during procurement.
Get to value without replacing a single system.
Trell starts with the records your team already uses. No new formats, no migration, no rip-and-replace. The first output is a concrete set of findings on one real decision, not a demo.
Select a starting scope.
Choose one product, process, package, or CDMO handoff. A narrow scope means a faster first output.
Provide representative source records.
Trell works with the records your team already uses. No new formats, and no system to replace.
Trell maps the execution trail.
It connects the records into a structured, source-linked execution trail and surfaces findings, gaps, and mismatches.
Trell returns a first findings set.
A concrete set of findings tied to the exact scope you provided, each linked back to its source record.
Your team reviews and defines the next scope.
Quality, MS&T, CMC, or External Manufacturing review the findings and decide where to expand next.
One product, one record set you already hold, findings in your hands within 30 days of data receipt, fully creditable against a subscription. If the findings don't change what you'd do next, we'll tell you, and we won't ask for a second call.
Common questions.
Questions from Quality, MS&T, CMC, External Manufacturing, IT, procurement, and security teams evaluating Trell.
Does Trell replace MES, EBR, QMS, LIMS, ELN, or Veeva?
No. Trell sits across those records and makes the execution trail usable for release, transfer, investigation, and CMC decisions. Those systems remain the systems of record.
Does Trell control manufacturing execution?
No. Trell does not run the batch or provide operator control. It helps teams understand whether the records, plan, execution, and evidence line up.
Who makes the final decision?
Human review and approval stay with the customer. All release, transfer, investigation, and CMC decisions are made by the qualified team. Trell supports the decision. It does not make or replace it.
What is the difference between Support Mode and Validation Mode?
Support Mode is the default at go-live: Trell runs alongside your validated systems, read-only, as a decision-support tool. Your systems of record stay authoritative and your qualified reviewer makes every call. Validation Mode is client-elected: when your use case requires Trell inside a GxP-controlled workflow, it establishes 21 CFR Part 11 controls through a separately scoped validation engagement. We can walk through how Trell fits your CSA and validation approach during evaluation. Most teams start in Support Mode and move only if and when they need to.
Is Trell a validated system?
Trell is not a system of record and does not replace validated systems. In Support Mode it works alongside them. In Validation Mode it can be operated under 21 CFR Part 11 controls and qualified through your validation lifecycle. Validation fit is scoped during procurement.
How does Trell connect source records to decisions?
Trell maps the execution trail across batch records, process documents, QC outputs, deviations, and CDMO packages. Findings link directly back to source records, sections, and fields, so a reviewer can confirm each value at its source.
Does Trell use customer data to train AI models?
No. Your data is not used to train any model, ours or a third party's, without your prior written consent, which you can withhold or withdraw; no such consent is in place today. Records, outputs, and findings processed through Trell remain the customer's data.
Can Trell work with CDMO packages?
Yes. Trell is designed for sponsor and CDMO use cases where records, expectations, and package evidence need to be compared before decisions move forward.
What records are needed to start?
A typical starting scope includes batch records, process documents, specs, methods, QC outputs, analytical reports, deviations, CDMO packages, or prior process history. Trell works with records teams already have.
How quickly can a team see value?
The first output focuses on a narrow use case and returns concrete findings from representative records. The goal is a real finding on a real decision, not a generic demo.
How does security review work?
Trell supports customer security and vendor review processes and can provide available documentation during procurement.
Start with one decision.
Send us one real record set: a release, an APR pull, a comparability package, or a CDMO record set. We will return the evidence traced to source, under your security terms and under NDA, in an isolated environment, within days, before you commit to more.