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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

Environmental Monitoring Management (Microbilogy)

Digitizes viable environmental monitoring across controlled areas, including air, surface, and personnel sampling. Manages sampling schedules, incubation records, colony counts, and alert/action limits within a compliant framework. Realtime trend visibility and excursion alerts strengthen contamination control and sustain inspection readiness across regulated operations.

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Core Features

Environmental Monitoring Planning & Scheduling

  • Define EM plans for viable, nonviable, air, surface & personnel monitoring
  • Automated schedules for sampling at defined frequencies
  • Preconfigured location maps with monitored points
  • Alerts for missed, due or overdue sampling activities

Digital Data Capture & Trend Reporting

  • Electronic recording of microbial and particulate counts
  • Attach plates, test results, chromatograms & observations
  • Automated trending to identify excursions and contamination sources
  • Realtime dashboards for alert, action and historical trends

Compliance, Traceability & OOS/OOT Integration

  • Timestamped audit trails for every EM activity
  • ALCOA+ compliant data integrity controls
  • Seamless linkage with OOS, deviation & CAPA workflows
  • Inspection ready reporting aligned with GMP & ISO cleanroom standards

Key Benefits

Strengthens contamination control in regulated cleanroom environments

Real-time trend visibility for proactive quality decisions

Excursion alerts enable rapid corrective action

Sustains inspection readiness across all controlled environments

Reduced regulatory and business risks

Business Benefits

Accelerates contamination event response with real time alerts and continuous EM monitoring

Enables early detection of emerging contamination trends through ongoing data analysis and excursion visibility

Reduces cleanroom related production risk by identifying issues before they impact aseptic operations

Supports Annex 1 contamination control strategy compliance with structured, traceable EM documentation

Simplifies environmental monitoring administration by eliminating manual data recording across thousands of tests

Strengthens inspection readiness by maintaining complete, audit ready records for all controlled cleanroom environments

60%

Faster Contamination Event Response

5,000–20,000 Tests

Annual Manual EM Entries Eliminated

3× Earlier

Trend Detection Through Continuous Monitoring

$1M–$10M+

Cost Exposure Avoided From Sterility Related Incidents

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.

Viable air sampling (volumetric and settle plate), surface sampling (contact plates, swabs), and personnel sampling (finger dab, gown sampling) across all cleanroom classification grades.

Sampling points are registered with room classification, location, and monitoring type. Schedules with defined frequencies are configured per room and area with automated reminders when sampling is due.

Incubation records capture incubation start and end times, temperature, and observer details for each sample providing complete documentation from sampling through final colony count result.

Alert and action level limits are configured per sampling point and ISO grade. When colony counts approach or exceed these limits, automated notifications are sent to designated personnel for immediate response.

Excursion alerts immediately notify the teams. An investigation workflow is triggered, with links to CAPA if the root cause requires longterm corrective action.

Realtime trend visibility dashboards show environmental monitoring results by room, sampling point, organism type, and time period enabling early detection of contamination trends before action levels are breached.

For Grade A/B aseptic areas, the module manages zero tolerance monitoring with immediate alert response supporting compliance with EU GMP Annex 1 (2022) requirements for contamination control.

Complete monitoring records, trend data, excursion history, investigation records, and CAPA are digitally stored and instantly retrievable demonstrating a robust contamination control program.

Yes. The module's structured environmental monitoring program management is aligned with the enhanced contamination control strategy requirements of the EU GMP Annex 1 2022 revision.