Pharma & Clinical QC

Reduce manual QC checks and prepare complete records for review.

Scispot’s Digital Brain captures results, applies configured checks, and routes exceptions. Analysts and Quality share the criteria, source evidence, and review steps needed to prepare controlled outputs. Authorized reviewers retain the final decision.
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Explore LabOS

Trusted by 200+ life science labs

Supporting 250+ instrument types, more than 1,000 experiments each month, and millions of samples across diagnostics, genomics, biotech, and regulated testing.

Your best fit

For pharmaceutical QC and clinical quality teams preparing complex reviews.

Keep your instruments, LIMS, and QMS. Start with one specification-driven test or clinical control workflow where manual checks and missing evidence delay review.

Map your QC review workflow
Features

Published Customer Outcomes

Reported results from one pharmaceutical QC workflow.

30%

Less manual data entry

Cut manual data entry for a pharmaceutical QC lab.

40%

Faster COA generation

Accelerated CoA generation for a pharmaceutical QC lab.

< 3 mnths

From disconnected tools to live operations

Brought one clinical lab live without disrupting operations.

0

Additional staff needed to scale

Helped one clinical lab scale without adding staff.

One system, three layers

One Digital Brain for QC criteria, evidence, and authorized decisions.

Assign Criteria & Prepare Tests

Assign pharmaceutical samples their effective specification, panel, method, units, and limits. Clinical QC records control material, lot, level, analyzer, analyte, and test-system rules.

Check required records before work proceeds. Carry approved criteria into each task and preserve versions so later changes cannot alter earlier results. Each workflow keeps its own approval path.

Check Results & Route Exceptions

Import supported analytical results against applicable criteria. Retain original records, calculation inputs, and method context.

Smart Actions prepare configured calculations and checks for review before changes are accepted. Route missing data, pharmaceutical OOS results, and clinical control exceptions to assigned reviewers, with visible checks and source evidence behind every flag.

Review Evidence & Prepare Outputs

Build reviews from original results, investigations, authorized follow-up tests, and conclusions. Link laboratory evidence to the QMS when it owns the formal investigation and corrective actions.

Prepare COAs from approved pharmaceutical results for controlled issue. Clinical QC retains separate actions and approvals. Responsible reviewers determine conclusions, disposition, or clinical action; prior results remain intact.

One connected operating layer

Bring complete QC evidence to the people making the decision.

Capture results, check configured criteria, and route unresolved work with its source records. Reviewers can focus on the investigation and next authorized action.

Find QC records needing attention
and inspect their evidence.

Trace the criteria and history behind the answer.

Meet Scibot
Scibot, the Scispot AI coworker
Which results used the previous specification version?
Show open OOS investigations for this material.
Compare control results across these reagent lots.
Which results are awaiting second review?
Trace this COA value to its source.
Summarize unresolved exceptions before this disposition.
Which results used the previous specification version?
Show open OOS investigations for this material.
Compare control results across these reagent lots.
Which results are awaiting second review?
Trace this COA value to its source.
Summarize unresolved exceptions before this disposition.
AI-native lab transformation

Practical tools for QC,
‍review queues, and controlled reporting.

Review Screens Built for Quality

Jazz gives analysts and Quality personalized review screens on shared Scispot data. Bring effective criteria, source results, exceptions, and required approvals together with role-based permissions.

Results from Your Existing Systems

GLUE imports supported analytical outputs into test, sample, or control records. Defined mappings preserve source, method, and calculation context while your LIMS and QMS retain agreed responsibilities.

Configured Checks with Visible Inputs

Smart Actions prepare configured calculations and checks. Preview outputs, review proposed changes, and route exceptions with source inputs and criteria. Authorized reviewers retain final Quality decisions.

Scientists and Engineers for Delivery

Scispot scientists and engineers map a QC pathway, configure screens and checks, test passing, flagged, and incomplete records, and train users. Measure reviewer preparation, exception age, and adoption.

Remove repeated checks and evidence assembly from QC work.

01

Specification-Driven Pharmaceutical Testing

Prepare controlled COAs from reviewed tests and effective specifications.

Assign raw-material, in-process, finished-product, or stability samples their tests and specification version. Import supported results and prepare configured calculations and acceptance checks, preserving source records.

Route exceptions and incomplete evidence for review. Populate COA templates from selected, approved results, linked to the material lot and decision record. Product release remains within the defined Quality process.

Explore pharmaceutical QC workflows

02

Clinical Control Lot Review

Prepare control reviews with lot history, flags, and follow-up tasks.

Capture control and reagent lots, level, analyzer, analyte, method, and applicable rules. Match supported results to the record and surface configured exceptions for review.

Show recorded trends and source evidence behind each flag. Assign follow-up work with its owner, action, and evidence. The clinical laboratory reviews control performance and documents actions under its own quality procedures.

Explore clinical control review workflows

03

Investigation and Disposition Evidence

Route flagged results with the evidence needed for an accountable decision.

Preserve the original pharmaceutical result, source file, method, and effective criteria. Route review tasks and link the QMS investigation where that system owns the formal process.

Record authorized follow-up tests and their rationale without replacing earlier results. Responsible teams determine cause and disposition. Unresolved work stays visible before controlled outputs can be issued.

Explore QC investigation workflows

Remove repeated checks and record chasing from one QC workflow.

Bring a specification or clinical control example. Our scientists and engineers will scope data, checks, approvals, and handoffs, then measure manual effort or review time.
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FAIR data • pipelines • automation

Instruments • ELN/LIMS/SDMS • 200+ connectors

FAIR data • pipelines • automation

Instruments • ELN/LIMS/SDMS • 200+ connectors

Frequently asked questions

How does this support both pharmaceutical and clinical QC?

Scispot’s Digital Brain captures results, applies configured checks, routes exceptions, and prepares controlled outputs. Pharmaceutical QC links material tests to specifications and Quality disposition. Clinical QC monitors test-system controls and records laboratory actions. Each keeps its own criteria, personalized apps, and approval path on the shared platform.

Can Scispot work with our instruments, LIMS, and QMS?

Yes. Supported files and agreed interfaces connect analytical results, sample and test records, and quality references. Define identifiers, criteria versions, mappings, source retention, handoffs, and access or export needs. Your QMS can retain formal investigations and corrective actions while Scispot supplies laboratory evidence and task status.

How do we configure and activate the first QC workflow?

Choose one pharmaceutical test-to-report or clinical control-review path. Scispot scientists and engineers map criteria, calculations, exceptions, and approvals; configure the app; test passing, flagged, missing, and changed records; and train users. Your Quality team approves methods, rules, procedures, and intended-use validation. Measure manual checks, reviewer preparation, or exception age before expanding.

How are OOS results and follow-up tests handled?

Keep the OOS result linked to its original source and applicable criteria. Scispot routes review and connects investigations, authorized follow-up work, and conclusions. Responsible reviewers and your procedures determine the investigation, justification for further testing, and final disposition. A later passing result never erases the earlier record.

Does Scispot make our QC workflow compliant or release results for us?

Scispot provides technical controls and supporting records. Compliance depends on intended use, procedures, configuration, and validation; Trust Vault organizes associated evidence. Your laboratory and Quality teams retain method suitability, investigations, clinical actions, validation, and final approvals. The agreed workflow can require those approvals before controlled outputs are issued.

Controls that support your quality system and accountable reviewers.

Permissions, audit history, electronic signatures, controlled review, and validation evidence support your procedures. Your organization retains method suitability, investigations, clinical decisions, and authorized disposition or release.