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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

eCalPM – Breakdown

Maintenance

Streamlines fault reporting, corrective actions, and repair workflows through structured and transparent digital processes. Real time notifications and automated approval mechanisms enable faster response times and efficient coordination among maintenance teams. Captures root cause analysis, corrective and preventive actions, and repair documentation in a centralized digital repository. Post maintenance quality reviews and impact assessments ensure that equipment is restored to a validated and compliant state after every repair.

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Core Features

Rapid Breakdown Logging & Issue Capture

  • Instant recording of equipment failures with root-cause details
  • Attach images, documents & observations for accurate issue reporting
  • Automatic categorization by criticality & equipment type
  • Prioritization of urgent breakdowns for faster response

Digital Work Orders & Technician Assignment

  • Auto‑generated work orders with task details & checklists
  • Technician assignment with time-stamped updates
  • Track repair progress from initiation to closure
  • Capture spare parts usage and repair notes digitally

Reliability Insights & Regulatory Compliance

  • Analysis of repeated failures to identify recurring problems
  • Integrated CAPA linkage for equipment requiring corrective action
  • Complete history of breakdowns, repairs & downtime
  • Inspection‑ready logs aligned with GMP & engineering standards

Key Benefits

Minimizes equipment downtime with rapid response

Equipment restored to validated and compliant state after every repair

Reduces operational risk through structured breakdown management

Improves response efficiency and documentation accuracy

Maintains consistent production performance

Business Benefits

Improves maintenance response efficiency with immediate alerts and structured digital workflows

Prevents recurring breakdowns through consistent root‑cause analysis and integrated corrective actions

Minimizes the impact of equipment disruptions by enabling faster recovery and reducing production delays

Strengthens GMP compliance by ensuring repaired equipment undergoes mandatory quality checks before reuse

Streamlines breakdown documentation with standardized digital reporting and complete traceability

Maintains stable production performance by eliminating undocumented incidents and enforcing controlled maintenance practices

30–50%

Reduction in Mean Time to Repair (MTTR)

$10K–$50K+ / hr

Typical Cost Avoided from Downtime

20–35%

Reduction in Repeat Breakdowns

60%

Reduction in Breakdown Documentation 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.

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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.

Any authorized user can initiate a breakdown report from any networked computer. Immediate notifications are automatically sent to maintenance teams, supervisors, and relevant departments — eliminating phone-based manual communication chains.

Breakdown categorization allows classification by failure type (electrical, mechanical, instrumentation, process-related), severity level, and urgency directing the appropriate response workflow.

Corrective actions are assigned to specific technicians or workgroups through the system. Work assignments include instructions, priority level, and completion deadlines.

RCA documentation is a required element of the breakdown closure workflow. Findings are captured in the centralized digital repository, enabling trend analysis to identify recurring failure modes.

Post maintenance quality reviews and impact assessments are mandatory before equipment is returned to service. If the breakdown impacts validated status, requalification requirements are triggered.

When a breakdown root cause analysis identifies a systemic issue requiring long term corrective action, the module initiates a CAPA directly ensuring preventive action is taken to avoid recurrence.

The equipment log is automatically updated with breakdown details, repair activities, and return-to-service status maintaining a complete, tamper-proof maintenance history.

Yes. Breakdown trend analysis identifies equipment with high failure frequency, enabling data-driven decisions about equipment replacement, enhanced PM, or process changes.

Workgroup creation within the breakdown record allows multiple teams (engineering, QA, production) to collaborate with clear assignments, communications, and progress tracking.

Reports include breakdown frequency by equipment, mean time to repair (MTTR), breakdown cost analysis, repair history, and trend analysis by failure category — supporting engineering performance reviews.