Sapio QC LIMS | Quality Control LIMS for GMP Lot Release
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Quality Control LIMS for GMP Manufacturing

Sapio QC LIMS

Accelerate lot release with AI-enabled sampling plans, guided QC workflows, reagent and instrument tracking, specification-driven assay review, and COA/COR generation — built on Sapio’s Science-Aware™ Platform.

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21 CFR Part 11 & EU Annex 11 GxP-validated Faster lot release
Sapio QC LIMS Cross-Batch Analysis Report mockup
Why Sapio QC LIMS

Bring sampling, testing, review, and release into one controlled workflow.

For regulated QC labs, speed only matters when the evidence is complete. Sapio QC LIMS connects the records and workflows that determine whether a batch can move forward.

Automated Sampling Plans

Create product-specific sampling plans, configure AQL thresholds, and generate the right sample work from test configurations.

Guided QC Execution

Route samples into role-based process queues and guide technicians through controlled workflow steps.

Reagent and Instrument Controls

Capture reagent lots, inventory impact, expiration context, and instrument readiness during the method workflow.

Specification-Driven Results

Evaluate analytical results against valid ranges, warning ranges, and pass/fail criteria configured at the process level.

Traceable Batch Review

Inspect lots, samples, assay results, process progress, hierarchy, and workflow history from connected records.

COA and COR Generation

Generate Certificates of Analysis and Certificates of Release from the lot record with electronic signature support.

Sampling plan AQL · Product Technician QC Guided workflow Results review Spec ranges Batch review Disposition COA / COR Release e-Signature applied
Lot Release

Release readiness starts before the first result is entered.

Sapio QC LIMS helps teams define the right work at the product and lot level, capture execution evidence at the bench, apply specifications automatically, and keep QA review connected to the underlying data.

  • Sampling plan setup tied to drug product and lot context.
  • Process queues that show analysts exactly what is ready.
  • Technician workflows that capture samples, reagents, instruments, criteria, and results.
  • Lot review and release documentation built from the governed record.
Traceability

Every assay result should know where it came from.

Traceability is not just an audit requirement. It is the difference between a fast investigation and days of record-gathering. Sapio QC LIMS links project, drug product, lot, sample, assay result, reagent, instrument, workflow history, and certificate output.

  • Navigate from sample record to batch, drug product, and top-level project.
  • Review sample metadata, storage, quantity, concentration, and workflow progress.
  • Search and chart data across related QC records for trending and reporting.
Lot Record Project Product Sample Assay result Reagent lot Instrument
No-Code Configuration

Adapt controlled QC processes without rebuilding your LIMS.

Admin users can configure fields, workflow entries, reusable protocols, unit operations, specifications, warning ranges, process versions, and report logic.

01

Define QC attributes and fields.

02

Build workflow entries and protocols.

03

Set process unit operations and specifications.

04

Publish governed versions with e-signature.

Best-fit use cases

Where Sapio QC LIMS fits

  • GMP QC labs replacing spreadsheets, paper, or rigid legacy workflows.
  • Teams that need product-specific sampling plans and batch release workflows.
  • Organizations that want integrated reagent, instrument, assay, and certificate context.
  • QC groups that frequently add products, methods, specifications, or review requirements.
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See it in action

See Sapio QC LIMS manage a lot from drug product setup and sampling plan creation through technician execution, assay review, certificate generation, and no-code process publishing.

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