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General Information

LIMS

Laboratory Information Management covering lab orders, specifications, certificates of analysis, stability studies, and reagent and sample warehouse — connecting lab operations to GMP compliance in one traceable system.

Explore LIMS Modules

LIMS Modules

Five modules covering the complete laboratory workflow — from specification definition and order issuance to results, certificates, stability programs, and sample storage.

Lab Orders

Issue lab orders against registered specifications, assign to analysts, capture results, flag OOS findings, and trigger investigation workflows automatically.

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Lab Specifications

Define and version test specifications for raw materials, intermediates, and finished products — with approval workflows ensuring only authorised specs are used in active lab orders.

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Certificates of Analysis

Generate CoAs directly from completed lab order results — controlled templates, electronic approval, and a traceable link back to the test data and specification version used.

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Stability Studies

Define protocols per ICH Q1A, schedule time-point testing intervals, capture results at each pull point, and detect out-of-trend conditions before they become out-of-spec failures.

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Warehouse

Manage reagent and sample storage with inventory tracking, expiry monitoring, and quarantine controls — ensuring lab materials are in-specification and traceable at the point of use.

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Key Features

Spec-to-Result Traceability

Every lab result links back to the exact specification version it was tested against — critical for batch release decisions and regulatory review.

Automatic OOS Handling

Out-of-specification results trigger structured investigation workflows automatically — no manual handoff, no results sitting unactioned in a spreadsheet.

ICH Q1A Stability Protocols

Stability programs follow ICH Q1A time-point schedules with automated pull reminders, structured result capture, and out-of-trend detection.

CoA Generation from Test Data

Certificates of Analysis are generated directly from approved lab order results — eliminating manual transcription errors and the risk of issuing a CoA that doesn't match the actual data.

Reagent Expiry & Quarantine Control

Warehouse tracks reagent expiry dates and quarantine status — preventing expired or unapproved materials from being used in active testing.

Analyst Assignment & Workload Tracking

Assign lab orders to specific analysts, track completion status, and maintain a clear record of who performed and who reviewed each test.

Full Audit Trail

Every result entry, approval, amendment, and CoA issuance is logged with timestamp and user identity — ready for data integrity review at any time.

GMP Integration

OOS results and lab investigations connect directly to the GMP quality system — deviations, CAPA, and change control records are created without duplicate data entry.

Need Help Getting Started?

Each LIMS module has dedicated documentation covering setup, workflows, and daily lab operations. Start with the module most relevant to your current laboratory priorities.