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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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Operations Modules

Preventive

Maintenance

Enables proactive asset management through automated scheduling, digital checklists, and comprehensive maintenance history tracking. Ensures timely servicing to reduce unexpected equipment failures and extend asset lifespan. Supports time based, usage based, and condition based maintenance strategies, allowing organizations to align maintenance activities with operational requirements. Integrated spare parts management, technician allocation, and performance analytics further improve maintenance planning.

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Core Features

Scheduled Preventive Maintenance Automation

  • Auto planned maintenance cycles based on time, usage or criticality
  • Real-time calendar for upcoming, due & overdue PM tasks
  • Technician assignment with automated reminders
  • Ensures equipment availability and minimized unplanned downtime

Digital Work Orders & Maintenance Execution

  • Electronic PM checklists with step-by-step task execution
  • Mandatory data capture to ensure compliance & accuracy
  • Attachments for images, manuals & service reports
  • Electronic approvals with 21 CFR Part 11 compliant signatures

Equipment Reliability Insights & Compliance

  • Performance and maintenance trend analysis dashboards
  • Full traceability of PM history, spare parts & technician actions
  • Integrated CAPA linkage for recurring equipment failures
  • Inspection-ready maintenance logs aligned with GMP expectations

Key Benefits

Reduces unexpected equipment failures

Extends asset lifespan

Minimizes production disruptions

Improves equipment availability and uptime

Ensures uninterrupted manufacturing operations

Automatic tracking status for all PM activities

Business Benefits

Reduces equipment failures by ensuring systematic, on‑schedule preventive maintenance

Extends equipment lifespan through proactive servicing rather than reactive repairs

Improves equipment uptime and availability, increasing overall manufacturing capacity

Minimizes production disruptions by eliminating unplanned downtime and maintenance‑related stoppages

Streamlines preventive maintenance administration with automated scheduling and standardized digital workflows

Optimizes spare‑parts usage through better tracking, forecasting, and maintenance planning

25–40%

Reduction in Unexpected Breakdowns

10–20%

Increase in Equipment Availability

15–25%

Extension in Equipment Lifespan

50–60%

Reduction in PM Administration Time

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

PharmaSoft is committed to empowering pharmaceutical and biotech teams with trusted, compliant, and fully validated digital solutions supported by expert guidance across quality, manufacturing, and laboratory operations.

Daily, weekly, fortnightly, monthly, quarterly, half yearly, and yearly PM schedules are supported configurable per equipment type and manufacturer recommendation.

PM checklists are configured per equipment type with required tasks, acceptance criteria, and sign off requirements. Checklists are version controlled and approval tracked like other GMP documents.

PM tasks are assigned to qualified technicians based on equipment type, location, and availability. Assigned technicians receive digital worksheets and automated notifications.

Completed PM checklists go through a configurable approval workflow before closure, ensuring supervisory or QA oversight of all maintenance activities.

The spare parts management feature tracks stock levels, usage per PM activity, and reorder requirements ensuring parts are available when scheduled PM activities are due.

Overdue PM activities trigger escalation notifications to supervisors. Equipment with significantly overdue PM can be flagged as restricted from use until PM is completed.

By ensuring all preventive maintenance activities are completed on schedule, the module reduces equipment failure rates by systematically addressing wear and potential failure conditions before they result in breakdowns.

Yes. The system is scalable to plant or enterprise-wide installation, with centralized PM management and site-specific equipment and technician assignments.

Dashboards include PM completion rates, overdue PM summary, equipment availability metrics, maintenance tracking, and auto-generated MIS reports in PDF format.

Yes. The module complies with 21 CFR Part 11 and EU Annex 11 requirements, supporting electronic signatures, audit trails, secure user access, and data integrity controls to ensure all maintenance records are secure, traceable, and audit-ready for inspections.