Biological Safety Cabinet
Class II Type A2 cabinets used for containment and aseptic laboratory operations, with airflow and certification requirements.
Life-science quality management
Your team qualifies the equipment. LS QMS runs the record.
Equipment qualification still runs on binders, tabs and memory. Ohtari LS QMS turns it into one controlled digital workflow — equipment registration through IQ, OQ and PQ execution, evidence capture, exception handling, review and electronic approval.
Product · LS Device Qualification
IQ / OQ / PQ
Qualification protocol
Refrigerated Centrifuge · CENT-0248
OQ execution82%
The problem
Qualification isn't slow because the protocol is long.
Thirty-page protocols are not the problem by themselves. The problem is the work around them — data entry, evidence collection, reviews, exceptions, and knowing what is actually done.
01 / PAPER
Documentation lives everywhere
Protocols in one binder, results in a spreadsheet, evidence in a shared drive, approvals in email. Reconstructing a single record takes hours.
02 / EXECUTION
Data is captured twice
Measurements are written on paper, then transcribed. Every transcription is another place a value can drift away from what was actually observed.
03 / CONTROL
Status is a guess
What is complete, what failed, what is waiting on review, and which equipment is still unqualified — none of it is visible without asking someone.
One controlled workflow
From equipment to approved record.
The full qualification lifecycle lives in one place, with status and evidence attached to the work rather than filed next to it.
01
Register the equipment
Create the device record — identifier, location, manufacturer, model, criticality and the qualification
requirements that apply to it.
Asset IDCriticalityRequirements
02
Execute IQ
Verify installation, configuration, utilities and supporting documentation against the approved
installation qualification protocol.
Installation checksDocumentationAttachments
03
Execute OQ
Run operational tests step by step against defined acceptance criteria, recording measured results
as the test is performed.
Acceptance criteriaMeasured resultsExceptions
04
Execute PQ
Document performance under intended operating conditions, with the runs, observations and supporting
evidence held against the record.
Intended usePerformance runsEvidence
05
Review and approve
Route the completed qualification through controlled review, resolve open exceptions, apply electronic
approval and close the record.
Review routingElectronic signatureQualification report
The platform
The work goes digital. The record stays controlled.
A purpose-built operating layer for equipment qualification and validation teams — protocols, execution, evidence, review and reporting in a single system.
01 / ProtocolsLive
Digital qualification protocols
replaces the printed protocol packet
Convert approved IQ, OQ and PQ procedures into structured execution workflows that guide the user through each required section in order.
IQ · OQ · PQProtocol types
02 / ExecutionLive
Evidence at the point of work
replaces transcription from paper
Capture measurements, observations, results and supporting attachments directly against the applicable test step, as it is executed.
Step-levelData capture
03 / CriteriaLive
Acceptance criteria & exceptions
replaces the exception spreadsheet
Define expected results up front and surface failed steps and open exceptions while the qualification is running, not at report time.
Pass / FailEvaluated in line
04 / ApprovalLive
Review & electronic approval
replaces the email approval chain
Route completed qualification records through controlled review and electronic approval, with reviewer, approver and date held on the record.
RoutedReview workflow
05 / TraceabilityLive
Traceable activity history
replaces "who changed this?"
Maintain a history of record creation, changes, approvals and qualification activity, attributable to the user who performed it.
AttributableAudit history
06 / ReportingLive
Qualification reports
replaces rebuilding the report by hand
Generate consistent qualification documentation from the completed digital record, with results and evidence already attached.
GeneratedFrom the record
Device libraries
Start with the equipment you already qualify.
Build reusable qualification templates per equipment type, so the second centrifuge takes a fraction of the effort the first one did.
Laboratory Refrigerator
Controlled-temperature storage for reagents, samples, standards and clinical materials, including mapping and alarm verification.
Refrigerated Centrifuge
Programmable centrifuges with speed, time and temperature controls, verified against defined operating set points.
Regulated workflow support
Designed for teams that need control, traceability and evidence.
LS QMS is designed to support GxP-regulated qualification workflows and electronic-record / electronic-signature requirements.
Controlled qualification protocols and templates
Electronic record and electronic signature workflows
Traceable, attributable audit history
Role-based access, review and approval
Structured, retrievable qualification records
System documentation to support validation
Relevant regulatory & industry considerations
21 CFR Part 11Electronic records and electronic signatures
GxPRegulated life-science operating environments
GMP / Annex 15Equipment qualification and validation workflows
GAMP 5Computerized-system validation approach
Listed for context, not as a certification claim. Compliance in your environment depends on your procedures, configuration and validation.
Questions
Answers before the call.
Do we have to rewrite our protocols?+
No. Your approved protocol content stays yours — LS QMS turns it into a structured execution workflow with the same sections, tests and acceptance criteria, so the executed record follows the procedure you already control.
What about qualifications already in progress?+
Teams typically start with new qualifications and the next scheduled requalifications, keeping in-flight paper executions on their existing path. Completed historical records can be registered against the equipment for reference.
How does this handle failed steps and exceptions?+
A step that misses its acceptance criteria is flagged where it happens, stays visible on the record, and carries its explanation and resolution through review — instead of being tracked in a separate spreadsheet.
Can it cover equipment types beyond the examples?+
Yes. Qualification templates are defined per equipment type, so the library grows with the devices your site actually qualifies — laboratory, production, storage and controlled-environment equipment alike.
How long does it take to get running?+
Ohtari deploys with your team rather than handing over a login. The usual starting point is one equipment type and one protocol set, running end to end, before the library is expanded.
See LS QMS in action
Turn qualification into a process that runs.
Walk through equipment registration, IQ/OQ/PQ execution, evidence capture, exceptions and electronic approval in one controlled digital workflow — with your equipment and your protocols.
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