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Add-on Modules

01

Trend Analysis Module

Statistical Control Charts & QC Trend Monitoring

Add-on Modules
Add-on Modules
Automates statistical analysis of laboratory results against pharmacopoeial specifications and internal control limits — generating Levey-Jennings charts, Shewhart control charts, and capability indices (Cp, Cpk) for real-time insight into process drift before it becomes an OOS event.
Key Capabilities
01Levey-Jennings02Shewhart Charts03Cp / Cpk Indices04Drift Alerts05PDF Reports
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Control Charts

Levey-Jennings & Shewhart visualisations per test.

OOT Detection

Automatic out-of-trend flags before OOS occurs.

Process Capability

Cp, Cpk and sigma calculations per parameter.

Historical Trending

Multi-batch & multi-period comparison views.

Export & Reports

PDF, Excel exports with audit-trail compliance.

LIMS Integration

Pulls result data directly from OasisLIMS.

02

Integrated Stability Studies

ICH-Compliant Stability Testing Integrated with LIMS

Bridges OasisLIMS with full stability study management — scheduling pull points, tracking chamber inventories, and logging test results in one workflow. ICH Q1A(R2) compliant with automated statistical shelf-life calculations and condition-based reporting for regulatory submissions.
Key Capabilities
01ICH Q1A(R2)02Chamber Tracking03Pull Scheduling04Shelf-life Stats05Regulatory Reports
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Protocol Setup

Configurable conditions, time-points & batches.

Chamber Inventory

Physical sample tracking across chambers.

Pull Alerts

Automated email reminders for upcoming pulls.

Regression Analysis

Statistical shelf-life with confidence intervals.

Degradation Graphs

Visual trend charts across conditions & time.

LIMS Link

Results logged directly from LIMS workflows.

03

Control Samples Management

Retention & Reserve Sample Tracking for QC Labs

Manages the complete lifecycle of control and retention samples — from registration and storage allocation to scheduled destruction — ensuring ICH and GMP compliance with automated alerts for expiry, pulls, and disposal authorisation.
Key Capabilities
01Barcode Registration02Storage Allocation03Expiry Alerts04Disposal Workflow05GMP Compliant
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Sample Registration

Barcode & label generation on intake.

Storage Mapping

Location-based placement & retrieval.

Expiry Notifications

Alerts before GMP hold period expires.

Disposal Records

Authorised destruction with audit-trail entry.

Sample Retrieval

Fast search by batch, product, or date.

Audit Trail

Complete record of all sample transactions.

04

Reference & Working Standards

Complete Lifecycle Tracking for Analytical Standards

Manages reference, working, and secondary standards from receipt to disposal — purity records, potency calculations, CoA linking, and usage logs — so every analytical test is traceable to a qualified, in-date standard with automatic reorder alerts.
Key Capabilities
01Purity Records02Potency Calculations03CoA Linking04Reorder Alerts05Traceability
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Standard Receipt

Registration with supplier CoA & lot details.

Preparation Logs

Working standard dilution & prep records.

Expiry Management

Alerts when standards approach expiry.

Usage Traceability

Links standards to each analytical test.

Reorder Management

Low-stock thresholds with purchase alerts.

Audit Trail

Full transaction history for inspection.

05

Equipment Calibration Management

Automated Calibration Scheduling & Due-Date Tracking

Centralises all lab instrument and equipment calibration records — scheduling, tracking, and alerting for due dates across balances, pipettes, HPLC, GC, spectrophotometers, and environmental monitoring equipment. GMP and ISO 17025 compliant with full certificate storage.
Key Capabilities
01Due-Date Scheduling02Overdue Alerts03Certificate Storage04Acceptance Criteria05Equipment Labels
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Equipment Register

Central inventory of all instruments & assets.

Calibration Schedule

Recurring schedules with auto next-due.

Pass / Fail Decisions

Auto-assessment against acceptance criteria.

Certificate Attachments

Attach external calibration certificates.

Out-of-Calibration Alert

Flags equipment used beyond due-date.

Calibration History

Complete timeline per instrument.

06

Chemicals & Reagents Management

GHS-Compliant Chemical Inventory & Usage Tracking

Full inventory management for lab chemicals, reagents, and solvents — receipt, storage, expiry, and disposal — with GHS hazard classification, SDS linking, usage logs per test, and low-stock alerts to keep labs safe, compliant, and never short on critical reagents.
Key Capabilities
01GHS Classification02SDS / MSDS Linking03Usage Per Test04Expiry Tracking05Low-Stock Alerts
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Chemical Receipt

GRN entry with supplier lot & CoA.

Stock Consumption

Real-time deduction on usage or dispensing.

Reorder Alerts

Configurable thresholds with notifications.

Hazard Labels

GHS pictogram labels with classification.

Disposal Records

Waste disposal log with method & authorisation.

Inventory Reports

Stock valuation, usage & audit-ready export.

07

Columns Management

HPLC & GC Column Lifecycle & Performance Tracking

Tracks HPLC, GC, and ion-exchange columns from procurement to retirement — recording injection counts, pressure histories, theoretical plate calculations, and maintenance events — preventing columns being used beyond spec and ensuring method reproducibility across instruments.
Key Capabilities
01Injection Counter02Pressure Logs03Plate Count Tests04Retirement Criteria05LIMS Assignment
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Column Registration

Unique ID with manufacturer & specs.

Injection Counting

Auto increment per test usage in LIMS.

Maintenance Log

Washing, equilibration & conditioning records.

Performance Charts

Plate count & asymmetry trends over time.

Retirement & Disposal

Auto-retirement when thresholds exceeded.

Instrument Assignment

Track which column is on which system.

08

Microbial Media Management

Batch Preparation & QC Tracking for Microbiology Labs

Manages the complete lifecycle of microbiological culture media — from powder receipt and batch preparation to sterility testing, QC promotion, and expiry — with pharmacopoeial growth promotion and inhibition results logged against each batch for full regulatory traceability.
Key Capabilities
01Batch Preparation02QC Promotion03Sterility Records04Growth Promotion05Expiry Tracking
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Media Receipt

Powder inventory with supplier CoA & lot.

Preparation Records

Weighing, pH, sterilisation logs per batch.

Growth Promotion

Pharmacopoeial results linked to each batch.

Sterility Testing

Sterility results with pass/fail decisions.

QC Approval

Two-person review before batch release.

Expiry Alerts

Notifications before media expiry date.

09

Volumetric Solutions Management

Standardisation & Factor Tracking for Titrimetric Methods

Tracks preparation, standardisation, and usage of volumetric solutions used in titrimetric analysis — recording molarity factors, revalidation intervals, and usage per test — so every titration uses a certified solution within its valid factor range, meeting pharmacopoeial requirements.
Key Capabilities
01Molarity Factors02Revalidation Intervals03Per-Test Traceability04Ph. Eur. / USP Ready05Expiry Alerts
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Solution Preparation

Recipe, weighing & batch size records.

Standardisation

Replicate titrations with mean factor.

Validity Period

Configurable revalidation intervals.

Test Linkage

Factor auto-applied to linked titrations.

Expiry Reminders

Proactive alerts before revalidation is due.

Factor History

Complete log of standardisation results.

10

Vendor Rating & Qualification

Supplier Quality Scoring & Qualification Management

Manages the complete supplier qualification and ongoing performance rating process — from qualification documentation, quality agreements, and audits to periodic re-evaluation scoring — ensuring only approved, high-quality vendors supply critical raw materials, chemicals, and reagents.
Key Capabilities
01Qualification Checklist02Performance Scoring03Quality Agreements04Re-evaluation Alerts05Approved Vendor List
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Vendor Registration

Supplier profile with categories & contacts.

Qualification Process

Document collection, audit & approval.

Performance Rating

Delivery, quality, CoA & service scoring.

Periodic Re-evaluation

Annual re-qualification alerts & workflow.

Approved Vendor List

Live AVL with qualified/conditional flags.

Vendor Scorecards

Summary performance reports by supplier.