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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
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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
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Quality Modules

Investigation

Management

Dedicated module for managing investigations as a structured, independent workflow separate from Deviations. Supports systematic and documented root cause investigation processes with risk driven methodologies across all investigation types in regulated manufacturing. Provides structured linkage to CAPA and related quality modules.

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Core Features

Investigation Intake & Structured Documentation

  • Dedicated investigation workflow separate from Deviations
  • Standardized documentation covering investigation details and evidence
  • Role based access control ensuring secure and authorized handling of investigation records
  • Complete audit trail capturing all investigation actions

Root Cause Analysis & Corrective Pathways

  • Structured RCA frameworks for accurate root cause identification
  • Risk driven investigation workflows ensuring depth based on impact
  • Seamless linkage to CAPA, Deviations, Complaints, OOS and Risk modules
  • Guided steps supporting systematic, end to end investigation discipline
  • Review and approval checkpoints for investigation completeness

Enterprise Oversight & Compliance Assurance

  • Clear separation of investigation processes for better precision and control
  • Strengthens compliance oversight with fully documented activity history
  • Improves RCA accuracy and supports proactive quality improvements
  • Inspection ready investigation records for audit preparedness
  •  quality across operations

Key Benefits

Separates investigation discipline from deviation tracking for greater precision

Improves root cause identification accuracy

Strengthens compliance oversight and audit readiness

Systematic documentation of all investigation activities

Business Benefits

Improves accuracy of root cause identification through structured, methodology driven investigation workflows

Accelerates OOS investigations with guided digital processes that support faster, more consistent decision making

Enhances batch quality by reducing investigation errors that often lead to unnecessary batch rejections

Strengthens regulatory compliance by ensuring complete, audit ready documentation for every OOS investigation

Improves investigation reliability through systematic root cause trending and integrated CAPA connectivity

Elevates quality governance by separating investigation discipline from deviation tracking for greater precision and oversight

35%

Higher Root Cause Accuracy

15–20%

Reduction in Batch Rejections

40%

Faster OOS Investigation Cycle Time

25%

Reduction in Repeat Investigations

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

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.

Bi-directional linking is supported across Deviations, Incidents, Audits, Complaints, CAPAs, and Risk modules, ensuring every investigation has a traceable source and that findings flow back to the originating quality event.

Yes. Workgroup creation, role-based task assignment, and collaborative documentation allow multi-disciplinary investigation teams to contribute within a single structured record.

The module generates investigation reports including executive summary, detailed findings, root cause conclusion, and recommended actions  suitable for regulatory review and management reporting.

Complete audit trails, electronic signatures, and structured documentation ensure every investigation record is inspection-ready and defensible during regulatory audits.

Yes. The Investigation Management module is designed to comply with 21 CFR Part 11 and EU Annex 11 requirements. It supports electronic signatures, secure user authentication, audit trails, data integrity controls, and role-based access, ensuring that all investigation records are secure, traceable, and audit-ready for regulatory inspections.

Yes. Workgroup creation, role-based task assignment, and collaborative documentation allow multi-disciplinary investigation teams to contribute within a single structured record.