GMP QC LIMS · Stability · CMC

QC workflows your scientists build, sign, and own — themselves

Compose assay processes from reusable templates, set the limits and reporting rules, dual e-sign, and publish to frozen, versioned processes. No developer ticket between your lab and a compliant new workflow.

Watch a Method Go Live ↓    See a Demo for Yourself
18+ reusable assay templates Dual e-signature approval Immutable, versioned processes Warning ranges before OOS
Sapio QC LIMS cross-batch QC assay analysis report — pass/fail by status, pass rates by test, top failing assays by lot
The Problem

Every assay change shouldn't wait in an IT queue

Your QC lab changes constantly — a new product, a revised limit, a corrected pick list, a new assay. When configuration sits behind a developer ticket and change control, each one costs weeks, the lab waits, and the change history fragments across ticketing tools and email. Your best people end up doing data entry instead of science.

Weeks → Hourstypical assay-change lead time (ticket + build + rework) versus a self-service, e-signed configuration
2 signaturesfrom two different people — GMP dual control built into publish, not bolted on
18+published assay templates in the library — compose, reuse, never rebuild
The Pipeline

Watch a method go from draft to frozen version

Six stages, one afternoon. Pick the process type, compose unit operations by dragging published assay templates, set the specs and warning ranges, attach the reporting rules, get two e-signatures from different approvers — and publish an immutable version your QA team can defend to any inspector.

Live simulation — scripted from a real GMP QC LIMS configuration session (Metformin HCl release testing · appearance + concentration · dual approval)
📚

Template Library

Process types & published experiment templatesidle
🧩

Compose

Drag templates into unit operations, in orderidle
📐

Specifications

Limits, critical flags, pick lists, warning rangesidle
🖨️

Reporting Rules

NMT limits, rounding, value-based precisionidle
✍️

E-Sign Approval

Two signatures, different approversidle
🧊

Publish & Freeze

Immutable versions, activate / deactivateidle
[sapio] booting configuration workspace…
0Unit operations
0Reported specs
0/2Signatures
—Critical specs
—Warning ranges
—Version
Approval — different approver required
Sapio Admin
Template Approver
approval not yet requested
Published versions
v1 · Metformin HCl Releasenot published
v2 · Metformin HCl Releasenot created
Proof of Output

Ask for a report. Get a report.

ELaiN, the AI co-scientist built into the platform, turns a one-sentence prompt into a finished analysis — drug-product pass/fail heatmaps, per-batch statistics, and lab KPI dashboards. Ask it to run one every Friday and email it to you, and it will. It works with the major AI assistants, and every request is access-controlled and logged like any other action in the system.

One-sentence prompts Works with Claude · Copilot · ChatGPT · Gemini Scheduled & emailed Access-controlled & auto-logged
Capabilities

Compliant by construction — and why it matters

🧩

Drag-and-Drop Composition

Build an assay process by dragging published experiment templates into unit operations. Order is preserved — workflow within unit operation, unit operation within process.

♻️

Reuse, Not Rebuild

An HPLC, visual inspection, or microbiology assay configured once is a reusable asset — across QC LIMS, Stability, and CMC processes, products, and sites.

📐

Specifications With Teeth

Every field is auto-discovered from the included templates. Flag criticals, decide what gets reported, set min/max acceptance, and constrain answers with pick lists.

⚠️

Warning Ranges — OOT Before OOS

Separate acceptance from warning limits (e.g., acceptance 280–320, warn 270–330). Drift is flagged the moment data is entered — before it becomes an investigation.

🖨️

Regional Reporting Rules Support

Control how numbers appear on reports: NMT reporting limits, value-dependent decimal precision, rounding modes. Consistent, defensible results, every time.

✍️

E-Sign + Immutable Versions

Publish with e-signature, dual approval from different people, and version freeze. Published versions are view-only; changes produce the next version. Full audit history.

Business Case

What this is worth to your lab

A representative QC lab moving from ticketed, developer-mediated configuration to self-service with GMP dual control.

Impact AreaTodayWith Self-Service ConfigurationAnnual Value
Assay / method change lead time2–6 weeks (IT ticket + build + rework)Same day — scientists configure, dual e-sign$50K–$200K in delayed release testing
OOS / investigation loadManual limits, drift caught at reviewWarning ranges + critical flags at the spec$30K–$150K in avoided false OOS investigations
New product / assay onboardingRebuild the process each timeCompose from reusable templates$20K–$100K in setup cost & time
Audit & inspection readinessChange history in tickets and emailImmutable versions + e-sign trail$50K–$250K in risk & finding cost

Conservative figures for a lab with ~10 method/assay changes a year and 2–4 false OOS events. The dominant value is the queue you remove — every change your scientists can make themselves, in hours, with the signature control QA already requires.

Who It's For

Built for the people who run the lab

QC Lab Leadership

Analytics and QC heads who own assay configuration and are tired of queuing behind IT for a revised limit.

QA & Compliance

Change control, e-signature, version history, and inspection readiness — defensible without a single spreadsheet.

Lab Operations

Managers chasing throughput: fewer queues, less rework, and data that is constrained at the point of entry.

CDMOs & Multi-Site

Contract and multi-site organizations that need the same compliant process replicated across clients and facilities.

See a demo for yourself

Book a live demo tailored to your lab — we'll compose one of your own assays: templates, specs, limits, warning ranges, and approval groups — and walk the full path from draft to frozen version.

See a Demo for Yourself