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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

Audit

Management

Digitizes the planning, execution, and closure of internal, customer, and regulatory audits. Centralizes findings, observations, and follow up actions while integrating directly with CAPA workflows. Real time dashboards enhance visibility into compliance health and reinforce inspection preparedness across the organization.

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Core Features

Audit Planning & Structured Execution

  • End to end planning and scheduling for internal, customer, and regulatory audits
  • Digital execution of audit activities with structured findings documentation
  • Centralized repository for observations, notes, and collected evidence
  • Alerts and reminders for all audit milestones and follow-up tasks
  • Validation-ready audit records ensuring regulatory compliance

Findings, Follow‑Up & CAPA Linkage

  • Unified management of findings, observations, and corrective actions
  • Seamless integration with CAPA workflows for timely resolution
  • Configurable follow‑up action tracking with clear accountability
  • Review and approval checkpoints for closure of audit findings
  • Complete history of audit activities for transparent traceability

Compliance Oversight & Inspection Readiness

  • Real-time dashboards giving visibility into enterprise compliance health
  • Strengthens inspection preparedness through structured audit documentation
  • Centralized audit data improving consistency across all audit types
  • Faster resolution cycles enabled by direct CAPA connectivity
  • Enterprise-wide oversight supporting proactive risk management

Key Benefits

Enhanced visibility into compliance health across the organization

Reinforces inspection preparedness

Seamless CAPA linkage for faster resolution of audit findings

Centralized audit record management

Business Benefits

Streamlines audit preparation with centralized, instantly accessible audit records

Accelerates audit finding resolution through integrated workflows and automated assignments

Improves audit quality by enabling proactive identification of systemic gaps and recurring issues

Ensures full traceability of all audit findings, supporting complete closure before inspections

Strengthens inspection readiness by reducing documentation gaps and eliminating manual preparation risks

Provides end to end visibility into organizational compliance health, improving governance and oversight

60%

Reduction in Audit Prep Time

25–30%

Reduction in Repeat Audit Findings

40%

Faster Finding‑to‑CAPA Response

50%

Lower Inspection Prep Costs

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.

Internal GMP audits, self-inspections, customer audits, regulatory inspections (FDA, MHRA, CDSCO), and system/process audits can all be managed within the system.

Audit schedules are created with defined scope, auditees, timelines, and objectives. The system notifies relevant teams in advance and tracks all pre-audit preparation activities.

Findings are categorized (critical, major, minor, observation) and documented digitally with evidence attachments, assigned owners, and due dates for corrective actions.

Audit findings are directly linked to CAPAs, ensuring every critical or major observation is addressed with corrective and preventive actions, along with effectiveness tracking.

Yes. Multiple auditors can contribute findings within the same audit, which are consolidated into a unified audit report at closure.

Auditees respond to findings within the system, with automated reminders for overdue responses. All responses and corrective actions are reviewed, approved, and tracked until closure.

The system provides audit summary reports, finding categorization, trend analysis by department or audit type, open CAPA status, and real-time compliance dashboards.

Real time dashboards and centralized records ensure all audit data, findings, CAPAs, and closures are inspection-ready and can be retrieved instantly during regulatory inspections.

The system tracks findings across audit cycles, flags repeat observations, and provides trend analysis to identify systemic gaps and drive continuous improvement.

Yes. The module complies with 21 CFR Part 11 and EU Annex 11, supporting electronic signatures, audit trails, secure access, and data integrity controls to ensure full regulatory compliance.