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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

softQMS

Change Control

Establishes a centralized governance framework for evaluating and approving changes across processes, systems, materials, and equipment. Embeds structured impact assessment, multi-level approvals, and risk evaluation to preserve validated states while ensuring regulatory compliance. Automated cross-functional coordination minimizes operational disruption and compliance exposure.

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Core Features

Change Initiation & Structured Impact Assessment

  • Initiation of change requests with documented reason and impact summary
  • Structured assessment of potential effects on processes, systems, materials, and equipment
  • Multi‑level review steps ensuring accurate evaluation before approval
  • Controlled workflow ensuring traceability from proposal to closure

Review, Approval & Implementation Governance

  • Multi‑level review, decision, and approval workflows for cross functional alignment
  • Implementation tracking with assigned action items and defined timelines
  • Automated alerts and reminders for pending tasks and overdue actions
  • Closure management ensuring all actions are completed and verified

Enterprise Oversight, Compliance & Change Analytics

  • Organization wide visibility into all active and closed Change Controls
  • Trend views highlighting recurring change categories, impact areas, and cycle times
  • Reduces risk associated with change through structured evaluation and governance
  • Enables smoother change implementation without disrupting day to day operations

Key Benefits

Change requests move through review and approval in a fraction of the time it takes on paper no chasing signatures across departments.

Every change is documented with a clear audit trail, so your team is never scrambling to reconstruct decisions during an inspection.

Impact assessments happen before implementation not after which means fewer change related deviations and CAPA events.

Multi-site teams stay aligned on the same approved change version, with no risk of departments acting on different revision states.

Finance and operations teams benefit too: fewer rework cycles and faster time to implementation reduce the cost of every change.

Business Benefits

Accelerates change execution using automated routing, structured workflows, and controlled parallel approvals

Reduces documentation workload by digitizing change records, impact assessments, and review steps

Strengthens compliance by enforcing mandatory approval gates and preventing incomplete or unauthorized changes

Improves inspection readiness by centralizing all change related evidence for faster regulatory query responses

Reduces downstream quality issues through systematic impact assessments that uncover risks before implementation

Enhances organizational control and visibility with easy tracking of all change controls across departments and sites

40%

Faster Change Implementation Cycle Time

30%

Reduction in Change‑Control‑Related Audit Findings

60%

Reduction in Change Documentation Effort

25%

Reduction in Change‑Related CAPA Volumes

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.

The module supports changes to processes, SOPs, equipment, materials, systems, facilities, and supplier/vendor changes any change that may impact product quality or regulatory compliance.

Approvers are configured by role and department. The system routes the change request sequentially or in parallel based on your organization's workflow design, with escalation alerts for overdue approvals.

Yes. softQMS supports bi-directional linking between Change Control, CAPA, Deviations, and Risk modules, ensuring full cross-module traceability.

The module includes an expedited change pathway with mandatory documentation of justification, abbreviated risk assessment, and post-implementation review requirements.

Configurable templates cover regulatory, product quality, process, validation, and training impact categories, ensuring comprehensive pre-change evaluation.

Automated email alerts and in system notifications are sent to designated reviewers and approvers at each workflow stage, including escalation reminders for overdue actions.

Yes. A real-time dashboard provides a summary and trend view of all Change Controls by status, type, department, and time period across the entire organization.

Yes. Risk evaluation is embedded within the change assessment workflow, allowing teams to assign risk levels and document mitigation actions before approval.

When a change requires document revision, softQMS automatically triggers a document update task in softDMS, ensuring no related SOP or specification is missed.

The module is aligned with ICH Q10, FDA Quality System Regulations, MHRA expectations, and GMP requirements for change control in pharmaceutical manufacturing.