Digital batch records that enforce compliance and accelerate release.
Unify document control, training, and quality events into a single, audit-ready platform that your team will actually love.
The batch waited three weeks. Manufacturing took one day. QC paperwork took twenty. Release testing that clears batches in days, not weeks.
Turn experiments into structured data AI can actually use.
Know exactly what you have, where it is, and when it expires.
ISO 13485, EU MDR, FDA 21 CFR 820. Design controls through post-market surveillance, with traceability that auditors actually believe.
Track calibration, maintenance, and usage. Block out-of-spec equipment automatically.
Development work in an execution system. When you go to GMP, you promote—not re-author. Tech transfer becomes configuration, not translation.
Adverse event case management, safety signal detection, and regulatory reporting. From MedWatch to EudraVigilance—patient safety in one system.
Unbreakable chain of identity from collection to infusion.
Turn structured data into regulatory-ready reports. No copy-paste. No formatting errors. No missing signatures.
Stop the version chaos. SOPs, policies, and controlled documents with automated workflows, training integration, and complete audit trails. The foundation your quality system needs.
Cleanroom monitoring, contamination trending, and excursion management. See your facility's microbial state in real time—not two weeks later.
Run multiple clients on shared facilities with perfect data isolation. Tech transfer in days, not months.
MSAT owns process knowledge across development, tech transfer, and manufacturing. Seal connects what other systems fragment.
The 2012 outbreak killed 64 people. A decade later, most 503B facilities still run on paper batch records and Excel EM logs. Pharmaceutical manufacturing standards with retail pharmacy tools don't work.
Study planning, site management, patient enrollment, and trial execution. Run clinical trials with the same rigor you apply to manufacturing.
The supplier nobody was watching. 12 lots rejected. 3 SCARs still open. Acceptance dropped from 94% to 87%. The data was there—nobody connected it into a picture.
Stop stitching systems together. Batch review with execution, testing, and deviations already linked.
Product registrations across markets, license lifecycle management, and regulatory intelligence. Know where you're registered, what's pending, and what's coming due.
Monday: FDA calls. Wednesday: they arrive. 48 hours to find the response letter with five commitments. Did you complete them? Audit readiness shouldn't be periodic panic.
PPQ closes in weeks, not months. CPV reporting in days, not weeks. Teams of five doing what teams of sixteen used to do—because the assembly disappears.
Your Trial Master File organized by TMF Reference Model, complete with real-time metrics, gap analysis, and audit trails. When the inspector arrives, you're ready.
The hazard nobody thought of. Surface texture harbored bacteria—nobody asked the question. Risk analysis that connects complaints to assumptions.
Module 3 generated from structured data, not assembled from copies. One source of truth across FDA, EMA, PMDA. When the inspector asks, reality matches the promise.
Design eCRFs, capture clinical data at sites, manage queries, and lock databases. Built for GCP compliance with the flexibility modern trials demand.
The promise nobody remembered. Eighteen months later, the inspector asks about your commitment—nobody who made it still works here. Track every regulatory obligation with deadline countdowns.
500 samples, meticulously stored for three years—consent didn't cover the new research use. Biobanking isn't freezer management. It's ensuring samples stay scientifically valid AND ethically usable.
Competency-based training with real-time dashboards, overdue tracking, and enforcement at point of work. Go beyond read-and-acknowledge.
Labels generated from source data—not retyped into Bartender. Every print event audited. Every scan linked to the record.
Track samples from collection to consumption. Chain of custody, storage locations, aliquoting, and requests—all with complete traceability. Never lose a sample again.
Capture instrument data automatically. HPLCs, mass specs, plate readers—all flowing into one searchable, traceable system with data integrity built in.
Complete learning management with course delivery, competency assessment, and qualification tracking. Build workforce capability, not just compliance.
Temperature warnings for two weeks—noted in the logbook, never escalated. PM overdue by a month. Friday the bioreactor failed. Monday was harvest. $2.3 million batch lost.
The lot was supposed to be in quarantine. Someone found it and used it. Status was in the system—physical location didn't enforce it. GMP warehousing requires controls that prevent, not just track.
Product B in 12 months, not 24. You already know temperature affects glycosylation—you proved it on Product A. Build control strategy from platform knowledge, not from scratch.
Chemical inventory, SDS management, hazard classification, and safety compliance. Know what you have, where it is, and how to handle it safely.
Purification development in an execution system. Chromatography, filtration, formulation—structured capture that survives tech transfer.
Cell culture and fermentation development in an execution system. Scale-up predictions from structured data. Process knowledge that survives tech transfer.
Method development with structure. When the method moves to QC, it promotes—parameters locked, validation linked, ready for GMP execution.
Eighteen months of data. One number that changes everything. The trend was visible—nobody was watching. Automatic trending shows you degradation trajectories before they cross limits.
From structured data to eCTD modules. Dossier generation, submission tracking, health authority correspondence—all from one source of truth.
Auditors ask, you answer—in seconds. Pre-assembled packages, instant document retrieval, complete audit trails. Ready before they arrive.
4.532 becomes 4.352. The product was fine—the certificate was wrong. Generate CoAs directly from validated LIMS data. No retyping. No transcription errors.
End the 'which version is current?' confusion. Version-controlled documents with automated workflows, training triggers, and complete audit trails.
Stop accepting 'human error' as a root cause. AI-powered pattern detection finds the systemic issues behind individual deviations.
Training completed. CAPA closed. Three more failures in the same suite. The CAPA that never actually worked. Mandatory effectiveness verification that proves your fixes work.
Approval is easy. Implementation is where change control fails. Track every affected document, training requirement, and validation until the change is truly complete.
The five-day clock started Monday. By Thursday you realized it was reportable. One day left. Intake triage that identifies critical complaints immediately, not after the queue.
1.2% moisture instead of 1.0%. Use as is. Six similar decisions in eighteen months—nobody connected the dots. NCMR workflows that surface patterns across dispositions.
The requirement nobody verified. Traceability showed gaps after the recall, not before. Design history files with live traceability that exposes gaps the moment they're created.
Show me the validation status of this equipment. Hours later, you're still assembling the answer. Manage IQ/OQ/PQ with status visible everywhere—equipment records, batch records, deviations.
The $400,000 mistake takes three seconds. Barcode verification blocks wrong materials—not warns, blocks. Balance integration eliminates transcription entirely.