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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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Quality Modules

Learning / Training

Management System

Delivers structured governance of workforce training and qualification across regulated environments. Manages role based curricula, training assignments, certification tracking, and periodic requalification within a compliance aligned framework. Automated training triggers linked to change control and document revisions ensure continuous workforce readiness. Web based application accessible to onsite and offsite employees.

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Core Features

Training & Competency Automation

  • Auto assign training based on role, function, and job profile
  • Track competency levels with requalification cycles
  • Automated due & overdue reminders
  • Integrated assessments with scoring logic

Centralized Learning Content Management

  • Upload SOPs, videos, PPTs, and e-learning modules
  • Version controlled training materials
  • Department based access control
  • Supports SCORM & multi-format content

Compliance & Audit-Ready Training Records

  • 21 CFR Part 11 compliant e-signatures & audit trail
  • Employee wise complete training history
  • Real time training matrix and compliance dashboards
  • Inspect ready records for QA & regulatory audits

Key Benefits

Eliminates missed training events across the organization

Reduces time, manual effort, and resources compared to manual systems

Ensures continuous compliance readiness across global operations

Supports regulatory inspections with complete training records

Centralizes all training activities scheduling, tracking, execution, and reporting

Business Benefits

Achieves near zero missed training events through automated assignments and reminders

Cuts training administration workload by up to 70% by eliminating all manual scheduling and tracking

Improves compliance outcomes, reducing training related regulatory findings by up to 40%

Delivers near instant inspection readiness, preparing training records in under 1 hour

Supports scalable global operations, managing training for teams of 50 to 5,000+ employees

Prevents costly GMP related training violations, avoiding incidents that can exceed $100,000 per FDA warning letter

95%+

On‑Time Training Completion

40%

Reduction in Training Non‑Compliance Findings

70%

Reduction in Admin Time

<1 Hour

Training Inspection Readiness

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.

softLMS supports various training types including Induction training, Initial training, GMP training, SOP-based training, On-the-job training (OJT), Field training, Refresher training, and Re-training.

The system supports multiple training delivery methods including Classroom training and Web based training, enabling flexible learning options for employees.

The system supports multiple training materials such as PDFs, videos, and SOP-based reading materials, all managed within a centralized platform.

The system includes assessments such as questionnaires after training sessions. Scores, pass/fail status, and attempt history are recorded to measure employee understanding and training effectiveness.

Automated escalation emails are sent to the employee and their supervisor. Overdue training is tracked in real-time dashboards and reported in compliance status views.

Yes. softLMS is web based, allowing onsite and offsite employees to access and complete assigned training modules from any authorized device. Additionally, centralized, audit ready training records with completion status, dates, scores, and trainer details can be retrieved instantly during regulatory inspections.

Based on departmental requirements and individual role assignments, the system automatically generates a comprehensive annual training schedule for the entire organization.

Yes. softLMS integrates seamlessly with modules like softDMS, Change Control, Deviation, and CAPA. This integration ensures that any document revisions, changes, deviations, or corrective and preventive actions automatically trigger relevant training assignments for affected personnel, maintaining continuous compliance and timely awareness.

softLMS provides comprehensive, real-time reports including topic-wise, person-wise, department-wise, and plant-wise training status. It also covers training completion, pending trainings, overdue trainings, individual training status, and annual training plan compliance all of which can be easily exported for management review and audit purposes.

Yes. softLMS is designed to comply with regulatory requirements including 21 CFR Part 11 and EU Annex 11. The system supports secure user access, electronic signatures, audit trails, data integrity controls, and role-based permissions, ensuring full compliance with regulatory expectations.