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  • Quality
    • Quality​ Modules
      softQMS – Change Control

      Centralizes compliant, risk-assessed change control with approved workflows.

      softQMS – Incidents Management

      Ensures structured documentation and assessment of quality events.

      softDMS – Document Management System

      Controls document lifecycles with compliance, security, and consistency.

      softQMS – Deviation Management

      Standardizes capture, investigation, and resolution of operational deviations.

      softQMS – Market Complaints Management

      Manages complaint intake, investigation, compliance, and risk control.

      Learning / Training Management System

      Tracks training, certification, and compliance readiness automatically.

      softQMS – Corrective and Preventive Action (CAPA)

      Institutionalizes CAPA management ensuring accountability, compliance, and continuous improvement.

      softQMS – Investigation Management

      Manages investigations with root-cause analysis and CAPA integration.

      Electronic Validation Management System

      Digitizes validation with compliance, traceability, and timely execution.

      More Modules

      softQMS – Audit Management
      VMS – Vendor Management System
      QRM – Quality Risk Management
      PQR / APQR – Annual Product Quality Review
      EDMS-Electronic Document Management System
  • Operations
    • Operations​ Modules
      softBMR – Electronic Batch Manufacturing Records (EBMR)

      Transforms batch records into intelligent, error-free electronic workflows

      eCalPM – Calibrations

      Manages instrument calibration lifecycle with compliance and traceability

      eCalPM – Breakdown Maintenance

      Streamlines repairs with tracking, root cause, and compliance

      MES – Manufacturing Execution System

      Digital backbone connecting production systems with real-time insights

      eCalPM – Preventive Maintenance

      Enables proactive asset maintenance with scheduling and analytics

       
       
      E-Log – Electronic Equipment Logbook

      Secure electronic logbooks replacing paper with compliant audit trails

      eCalPM – Annual Maintenance Contract (AMC) Management

      Manages maintenance contracts with tracking, alerts, and compliance

  • Analysis
    • Analysis/Laboratory​ Modules
      LIMS Masters – Specifications & Standard Test Procedures

      Centralizes lab master data with governance and compliance

      softLIMS – Instrument Management

      Tracks instrument lifecycle with compliance enforcement and integration

      softLIMS – Working Standards Management

      Manages working standards with traceability, alerts, and compliance

      softLIMS – Sample Management

      Manages sample lifecycle with tracking, compliance, and integrity

      softLIMS – Solutions Management

      Digitizes solution preparation with validation, tracking, and compliance

      softLIMS – Column Management

      Manages column lifecycle with tracking, alerts, and compliance

      softLIMS – Stability Management

      Automates stability studies with tracking, alerts, and trending

      softLIMS – Reference Standards Management

      Manages reference standards with traceability, validity, and compliance

      softLIMS – Control Samples Management

      Manages sample retention with traceability, alerts, and compliance

      More Modules

      softLIMS – Water Management
      Environmental Management System (Microbiology)
      softLIMS – Chemical Management
      softLIMS – Label Management
  • About Us
  • Contact Us
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  • Home
  • Quality
    • Quality​ Modules
      softQMS – Change Control

      Centralizes compliant, risk-assessed change control with approved workflows.

      softQMS – Incidents Management

      Ensures structured documentation and assessment of quality events.

      softDMS – Document Management System

      Controls document lifecycles with compliance, security, and consistency.

      softQMS – Deviation Management

      Standardizes capture, investigation, and resolution of operational deviations.

      softQMS – Market Complaints Management

      Manages complaint intake, investigation, compliance, and risk control.

      Learning / Training Management System

      Tracks training, certification, and compliance readiness automatically.

      softQMS – Corrective and Preventive Action (CAPA)

      Institutionalizes CAPA management ensuring accountability, compliance, and continuous improvement.

      softQMS – Investigation Management

      Manages investigations with root-cause analysis and CAPA integration.

      Electronic Validation Management System

      Digitizes validation with compliance, traceability, and timely execution.

      More Modules

      softQMS – Audit Management
      VMS – Vendor Management System
      QRM – Quality Risk Management
      PQR / APQR – Annual Product Quality Review
      EDMS-Electronic Document Management System
  • Operations
    • Operations​ Modules
      softBMR – Electronic Batch Manufacturing Records (EBMR)

      Transforms batch records into intelligent, error-free electronic workflows

      eCalPM – Calibrations

      Manages instrument calibration lifecycle with compliance and traceability

      eCalPM – Breakdown Maintenance

      Streamlines repairs with tracking, root cause, and compliance

      MES – Manufacturing Execution System

      Digital backbone connecting production systems with real-time insights

      eCalPM – Preventive Maintenance

      Enables proactive asset maintenance with scheduling and analytics

       
       
      E-Log – Electronic Equipment Logbook

      Secure electronic logbooks replacing paper with compliant audit trails

      eCalPM – Annual Maintenance Contract (AMC) Management

      Manages maintenance contracts with tracking, alerts, and compliance

  • Analysis
    • Analysis/Laboratory​ Modules
      LIMS Masters – Specifications & Standard Test Procedures

      Centralizes lab master data with governance and compliance

      softLIMS – Instrument Management

      Tracks instrument lifecycle with compliance enforcement and integration

      softLIMS – Working Standards Management

      Manages working standards with traceability, alerts, and compliance

      softLIMS – Sample Management

      Manages sample lifecycle with tracking, compliance, and integrity

      softLIMS – Solutions Management

      Digitizes solution preparation with validation, tracking, and compliance

      softLIMS – Column Management

      Manages column lifecycle with tracking, alerts, and compliance

      softLIMS – Stability Management

      Automates stability studies with tracking, alerts, and trending

      softLIMS – Reference Standards Management

      Manages reference standards with traceability, validity, and compliance

      softLIMS – Control Samples Management

      Manages sample retention with traceability, alerts, and compliance

      More Modules

      softLIMS – Water Management
      Environmental Management System (Microbiology)
      softLIMS – Chemical Management
      softLIMS – Label Management
  • About Us
  • Contact Us
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Analysis/Laboratory​ Modules

softLIMS

Sample Management

Digitally governs the complete sample lifecycle — from registration, test assignment, execution, review, approval, and final disposition. Provides real-time workload visibility, automated status tracking, and traceable result recording. Integrated OOS/OOT triggers and exception handling strengthen compliance oversight while improving turnaround efficiency. Designed to maintain the highest standards of safety, regulatory compliance, and data integrity.

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Core Features

End-to-End Sample Lifecycle Tracking

  • Capture and register samples with unique IDs & barcode support
  • Track sample movement from receipt to disposal
  • Automated alerts for due testing and upcoming stability pulls
  • Complete chain‑of‑custody for full traceability

Digital Sample Logbooks & Test Assignment

  • Electronic sample logbooks with version-controlled records
  • Auto‑assignment of samples to analysts or test plans
  • Attach COAs, specifications & supporting documents
  • Real-time visibility into testing queues and workloads

Compliance, Audit Trails & Data Integrity

  • Time-stamped audit trails for every action on a sample
  • ALCOA+ compliant data capture and storage
  • Deviation/OOS linkage for impacted samples
  • Inspection-ready reporting aligned with GMP requirements

Key Benefits

Maintains highest standards of safety, regulatory compliance, and data integrity

Reduces manual data entry and transcription errors

Faster turnaround through automated calculations and status tracking

Enables OOS/OOT investigation support

Improves analytical performance and on-time completion

Business Benefits

Accelerates laboratory turnaround with automated calculations, digital workflows, and streamlined approvals

Eliminates manual calculation and transcription errors through system‑driven data processing and validation checks

Standardizes analytical procedures using built‑in automated test method calculations across a wide range of analyses

Improves result reliability by removing false OOS/OOT outcomes linked to manual computation errors

Enhances COA processing efficiency with built‑in templates and automated certificate generation

Strengthens regulatory compliance through complete traceability, controlled records, and integrated investigation support

30–50%

Reduction in Laboratory TAT

15–45 min

Time Saved per Sample (Automated Calculations)

30%

Avoidable OOS Errors Eliminated

60%

Faster COA Issuance

Start Your Digital Transformation Journey

Empower your organization with GMP-compliant QMS, EBMR, LIMS, and Equipment Management solutions designed for Pharma 4.0.

📞 Contact Pharma Soft today to schedule a demo and discover how our platform can transform your regulated manufacturing operations.

Contact Us

Frequently asked questions

Pharma is committed to helping you access trusted lab and pharmacy solutions, with expert help at every step of the way.

Finished Products, Raw Materials, In-Process samples, Packing materials, API samples, and any other sample type registered in the laboratory — each with unique AR number generation.

Calculation templates are pre-configured/configurable for IP/BP/USP and in-house test methods calculations — eliminating manual computation.

When a result falls outside specification, the system automatically triggers an OOS workflow — preventing result finalization until the investigation steps are completed.

Work assignments are made by the laboratory supervisor within the system. Analysts receive digital worksheets for their assigned samples with current specifications and pre-configured calculation templates.

The system tracks analyst qualification status per sample category. Unqualified analysts cannot be assigned to sample types for which they are not qualified — enforcing GLP compliance.

Yes. Retest, Recheck, and reduced testing workflows are supported within the system, with full audit trail of all testing and re-testing activities linked to the original sample record.

Upon completion of testing and review/approval, the system auto-generates a COA populated with product details, test results, specifications, and with signatures.

Real-time dashboards show sample status (received, assigned, in testing, review, approved) by analyst, sample type, and department — enabling proactive workload management.

The system automatically generates trend graphs and trending data for key quality attributes per product/material — supporting ongoing process monitoring and stability trending requirements.

Automated calculations, digital worksheets, real-time result entry, and electronic review eliminate the sequential paper routing delays of manual LIMS — reducing average laboratory turnaround time by 30–50%.