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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

Instrument Management

Tracks instrument lifecycle status including registration, calibration schedules, preventive maintenance, breakdown history, and usage logs. Integrated alerts prevent testing on out of calibration instruments active enforcement, not just notifications strengthening compliance and ensuring analytical data reliability. Supports LAN, internet, and IoT connectivity for fully integrated LIMS use.

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Core Features

Complete Instrument & Equipment Lifecycle Tracking

  • Centralized repository for all laboratory instruments
  • Track installation, qualification, calibration & maintenance history
  • Auto alerts for due calibrations and requalification events
  • Document storage for manuals, certificates & service reports

Digital Calibration, Maintenance & Usage Logging

  • Electronic logbooks for daily, weekly & monthly instrument usage
  • Track breakdowns, service requests & corrective actions
  • Link calibration and maintenance activities directly to instruments
  • Real time visibility into instrument availability and downtime

Compliance, Audit Trails & Data Integrity Assurance

  • 21 CFR Part 11 compliant electronic signatures & time stamped logs
  • Role based access for controlled instrument data entry
  • Full audit trails for calibration, qualification & service operations
  • Inspection ready reports for QA and regulatory authorities

Key Benefits

Prevents testing on out of calibration instruments active system enforcement

Ensures analytical data reliability and compliance

Eliminates manual calibration tracking and scheduling

Supports IoT enabled lab instrument monitoring

Centralized instrument lifecycle management

Business Benefits

Prevents the use of out of calibration instruments through active system enforcement and real time equipment status checks

Strengthens laboratory compliance by ensuring calibration meets regulatory and quality expectations at all times

Streamlines instrument administration with automated scheduling, certificate generation, and centralized lifecycle records

Improves data integrity by integrating IoT data capture and eliminating manual transcription from instruments

Consolidates management of all laboratory instruments into a single controlled system for full operational visibility

Reduces quality and batch related risks by ensuring only verified and compliant instruments are used for testing

100%

Prevention of Out of Calibration Testing

$50K–$200K

Cost Exposure Prevented per Invalid Test Event

60–70%

Reduction in Instrument Administration Effort

10–20%

Avoidable Data Integrity Errors Eliminated

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.

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Frequently asked questions

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

HPLC systems, UV/Vis spectrophotometers, dissolution apparatus, balances, pH meters, Karl Fischer titrators, GC systems, IR spectrometers, microscopes, and all other QC laboratory instruments.

When an instrument's calibration is overdue, the system blocks it from being selected for test assignments active enforcement, not just a notification. Testing cannot proceed until calibration is completed and approved.

Upon completion and QA approval of a calibration activity, the system automatically generates a calibration certificate populated with instrument details, results, calibration date, and next due date.

Instrument breakdowns are logged within the system, triggering maintenance notifications. Instruments under repair are marked as restricted. Decommissioned instruments are formally terminated with documented justification.

Each instrument use event is logged with user identity, date, time, purpose, sample details, and electronic signature providing a complete, GLP compliant instrument use history.

A complete calibration history is maintained per instrument, including all past calibration results, trend data, deviation records, and corrective actions accessible for audit review.

Calibration worksheets support multi point calibration with individual tolerance evaluation at each test point  providing complete calibration coverage for instruments with multiple measurement ranges.

Reports include instrument master list, calibration schedule, overdue calibration summary, trend analysis, use log, Breakdown, and performance dashboards.

Yes. Automated notifications are sent for upcoming calibration activities, helping ensure timely compliance and uninterrupted laboratory operations.

Yes. The module complies with 21 CFR Part 11 and EU Annex 11 requirements, supporting electronic signatures, audit trails, secure user authentication, and data integrity controls, ensuring all instrument related records are secure, traceable, and audit-ready.