Paper & spreadsheet processes
Worksheets, logbooks and Excel calculations create rework, transcription risk and weak version control.
Laboratory Information Management System (LIMS)
Digitize your laboratory with a paperless, compliant and intelligent Laboratory Information Management System that manages the complete sample lifecycle — from registration to Certificate of Analysis — while ensuring complete traceability, instrument integration and regulatory compliance.
- 21 CFR Part 11
- EU GMP Annex 11
- GAMP 5 validated
- ALCOA++
OPS IQ LIMS
Laboratory Control Centre
184
Samples in test
27
Pending review
63
Released today
Turnaround time by day
Last 8 daysSMP-24019Assay — HPLCIn test
SMP-24012DissolutionUnder review
SMP-23998Water content — KFApproved
Modern laboratories face increasing complexity
Rising sample volumes, tighter data integrity expectations and disconnected instruments make manual laboratory operations unsustainable.
Compliance pressure
Part 11, Annex 11 and ALCOA++ data integrity expectations keep rising while lab headcount stays flat.
Disconnected instruments
HPLC, GC, balances and dissolution systems produce data that never reaches a governed system automatically.
Manual data transcription
Analysts retype results between instruments, worksheets and reports — the single largest source of lab error.
No real-time visibility
Sample status, analyst workload and pending reviews are only known by asking, not by looking at a dashboard.
Delayed batch release
Reviews, approvals and COA preparation queue up on paper, holding finished goods in quarantine longer.
Traditional laboratory versus OPS IQ LIMS
The same analytical work, executed with automation, connectivity and evidence instead of worksheets and follow-ups.
Traditional laboratory
- Paper worksheets and logbooks
- Manual routing and reminders
- Sample status tracked by hand
- Standalone, offline instruments
- Status known only on request
- OOS files reconstructed manually
- Traceability assembled for audits
- Lab data scattered across drives
OPS IQ LIMS
- Fully paperless laboratory records
- Automated, role-based lab workflows
- Digital sample lifecycle end to end
- Direct instrument and CDS connectivity
- Real-time dashboards and KPIs
- Guided, faster OOS/OOT investigations
- Complete, time-stamped traceability
- Centralised, searchable laboratory data
From registration to Certificate of Analysis
Every action in the lifecycle is time-stamped, attributable and fully traceable — from the moment a sample is logged to the day its record is archived.
Sample Registration
Samples registered against specification, batch and test plan.
Barcode / RFID
Unique labels drive scanning, custody and location tracking.
Sample Assignment
Tests allocated to qualified analysts and available instruments.
Testing
Results captured directly from instruments against method limits.
Review
Second-person review of results, calculations and raw data.
Approval
Electronic signature approval by the quality reviewer.
Certificate of Analysis
COA generated from approved data with no retyping.
Archive
Records retained with full audit trail for the retention period.
Everything the QC laboratory runs on, in one system
Instruments, CDS and enterprise systems connected to one platform
Results flow directly from the bench into governed laboratory records, and released data flows onward to the systems that depend on it.
Analytical instruments
HPLCUPLCGCDissolution SystemsKarl FischerBalances
Chromatography data systems
Empower CDSOpenLab CDSChromeleon
OPS IQ LIMS
Integration hub
Enterprise systems
SAP S/4HANAMESeQMSREST APIsBI Tools
Bi-directional
Instrument acquisition inbound, approved results and COA data outbound to ERP, MES and analytics — with the audit trail preserved at every hop.
Laboratory performance, visible in real time
Operational dashboards for supervisors, quality KPIs for managers and consolidated performance views for corporate QA.
Sample Status
Live view of registered, in-test, under-review and released samples.
Laboratory KPIs
Turnaround time, backlog, first-time-right and pending approvals.
Analyst Productivity
Tests per analyst, workload distribution and review throughput.
OOS Trends
OOS frequency by product, method, instrument and analyst.
Stability Trends
Trend plots across pull points, conditions and shelf-life projections.
Batch Release Performance
Time from last test to release, with bottleneck identification.
Instrument Utilisation
Usage, availability, calibration status and downtime by instrument.
Laboratory Performance
Consolidated site and multi-site laboratory performance scorecards.
Detect quality issues before they escalate
Built-in statistics turn laboratory results into early warnings and defensible, data-driven decisions — without exporting data to a separate tool.
Statistical Process Control
Control charts on critical parameters to separate signal from noise.
Capability Indices (Cp/Cpk)
Process capability against specification limits, by product and site.
Westgard Rules
Multi-rule evaluation to flag analytical runs before results are released.
Nelson Rules
Pattern detection on control charts for non-random behaviour.
Predictive OOT Analysis
Early warning when results drift toward specification limits.
Stability Trending
Regression and shelf-life trending across stability programmes.
APQR Analytics
Annual product quality review datasets generated from live lab data.
Statistical Reports
Publication-ready statistical reports for QA and regulatory review.
Measurable laboratory outcomes
0%
Faster batch release
0%
Reduction in manual transcription
0%
Higher analyst productivity
0%
Audit trail coverage
LIMS at the centre of your quality data landscape
One laboratory data core, connected to the operational, enterprise and analytical systems around it.
eQMS
eBMR
APQR
EAM
OPS IQ LIMS
Laboratory data core
SAP
Laboratory Instruments
Analytics Platform
Corporate QA
Built for regulated laboratories
Data integrity controls are enforced by the system, so inspection evidence is a report — not a project.
FDA 21 CFR Part 11
Electronic records and signatures with secure, computer-generated audit trails.
EU GMP Annex 11
Computerised system controls, access management and periodic review evidence.
ALCOA++
Attributable, legible, contemporaneous, original, accurate, complete and available data.
GAMP 5
Risk-based validation approach with documented lifecycle deliverables.
ICH Q10
Pharmaceutical quality system principles applied to laboratory operations.
Schedule M+
Revised Schedule M laboratory documentation and data control requirements.
Electronic Signatures
Meaning-bound signatures on result review, approval and COA release.
Audit Trails
Time-stamped, non-editable trails on every create, change and approval.
Role-Based Access
Least-privilege roles for analysts, reviewers, QA and administrators.
Validation Support
Pre-executed IQ/OQ, traceability matrices and change control evidence.
Why laboratories choose OPS IQ LIMS
Unified Quality 4.0 platform
LIMS shares one data model with eQMS, eBMR, APQR and analytics.
Pharma-grade compliance
Part 11, Annex 11 and ALCOA++ controls enforced at record level.
Embedded analytics
SPC, capability and trending built in — no separate BI project.
Native SAP integration
Batch, material and release data exchanged with SAP S/4HANA.
Multi-site deployment
Harmonised methods and specifications with site-aware governance.
Cloud or on-premise
Deploy in our validated cloud or inside your own data centre.
Scalable architecture
Scales from a single QC lab to enterprise laboratory networks.
Proven industry experience
Delivered by laboratory and validation practitioners.
A four-phase path to a paperless laboratory
01
Assessment & Discovery
Laboratory process mapping, instrument inventory, gap analysis and success metrics.
02
Foundation & Configuration
Specifications, methods, roles, workflows and label formats configured in your tenant.
03
Quality Digitization
Instrument interfaces, sample lifecycle, OOS/OOT, stability and COA go paperless.
04
Analytics & Expansion
Dashboards, SPC and trending enabled, then rollout to additional labs and sites.
LIMS questions, answered
The complete lifecycle: sample registration against a specification, barcode or RFID labelling, assignment to analysts and instruments, testing, second-person review, electronic approval, Certificate of Analysis generation and archival. Every action is time-stamped and traceable.
Transform your laboratory with intelligent digital quality
Empower your laboratory with a paperless, compliant and intelligent LIMS that improves efficiency, accelerates batch release and ensures complete data integrity.
- 45-minute working session on your own sample flow
- Instrument integration and COA walkthrough
- Validation and data integrity evidence review