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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

Water Management

Designed for pharmaceutical and biotech water analytical requirements. Manages various water sample types including Raw water, RO water, Purified Water (PW), Water for Injection (WFI), and utility systems. Automated alerts for OOS deviations and integrated reporting support environmental and regulatory compliance monitoring.

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Core Features

Water Sampling Configuration & Controlled Governance

  • Supports multiple water types: Raw, RO, PW (Purified Water), WFI, and utility systems
  • Water specification setup with in‑house or pharmacopoeial tests and parameters
  • Single or multiple sample logging with auto‑generated AR numbers

Digital Execution, Results Management & Automated Controls

  • Automatic worksheet generation for each sample
  • Results entry workflows with structured review and approval
  • Alert and action thresholds with automated OOS notifications
  • Schedule deviation alerts ensuring timely sampling

Compliance Monitoring & Enterprise Water Quality Assurance

  • Continuous monitoring ensures consistent water quality for manufacturing operations
  • Automated OOS/deviation alerts prevent compliance gaps and missed investigations
  • Integrated trending supports regulatory submissions and inspection readiness

Key Benefits

Regular water quality monitoring for consistent product quality

Automated alerts for OOS/deviations prevent compliance gaps

Integrated trending and graphing for regulatory submissions

Eliminates manual water analysis data tracking

Business Benefits

Accelerates water quality issue response through automated alerts, continuous monitoring, and rapid deviation visibility

Eliminates manual data handling by digitizing water test records, reducing operational effort and administrative burden

Prevents contamination risks by ensuring immediate detection of water‑quality failures before they impact production

Strengthens regulatory compliance with complete, traceable records required for inspections and product submissions

Improves audit readiness by providing structured, audit‑ready monitoring data and deviation history

Enhances product quality assurance through consistent trending, graphing, and real‑time status visibility

70%

Faster Response to Water Quality Exceedance

500–2,000 Tests

Typical Annual Manual Effort Eliminated

40%

Reduction in Water System Related Regulatory Observations

Instant

Access to Traceable Water‑Quality Records

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.

Raw water, RO (Reverse Osmosis) water, Purified Water (PW), Water for Injection (WFI), clean steam condensate, and utility system water all common pharmaceutical water types.

Sampling points are registered with location details, assigned to schedules with configurable sampling frequencies daily, weekly, or at other required intervals as per Water System qualification.

Alert and action level thresholds are defined per sampling point and water type. When results exceed thresholds, automated OOS notifications are triggered, directing appropriate investigation and response actions.

The system automatically generates worksheets for each scheduled sampling event, prepopulated with sampling point, required tests, and current specifications eliminating manual worksheet preparation.

Water System Management and Environmental Monitoring modules work in concert within softLIMS, providing unified visibility across both water and environmental monitoring programs.

Yes. Water specifications can be configured per applicable pharmacopoeia (IP, BP, USP, EP) or in house limits with test parameters and acceptance criteria defined accordingly.

Historical water data is stored and graphically displayed as trending data per sampling point and parameter suitable for water system annual reviews and regulatory submissions.

Structured, audit ready water testing records with complete sample registration, result entry, OOS documentation, and approval trails demonstrate a systematic water quality monitoring program to inspectors.

Schedule deviation notifications alert responsible personnel when sampling events are overdue. Deviations are documented and require justification, maintaining regulatory accountability for water monitoring schedules.

Yes. All water analysis records, approvals, and audit trails are captured with electronic signatures and timestamps fully compliant with 21 CFR Part 11 and EU Annex 11 requirements.