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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
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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

PQR / APQR – Annual Product

Quality Review

Unifies Product Quality Review and enterprise analytics into a single, data driven governance framework. Consolidates quality metrics, manufacturing performance, deviations, complaints, stability data, and CAPA outcomes into structured, inspection ready reviews. Enables regular periodic or rolling quality reviews of all registered products including export only items to highlight overall trends and identify product and process improvements.

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Core Features

Centralized Product Data & Structured Review Management

  • Online product data entry with realtime PQR/APQR status visibility
  • Consolidation of multisource data: quality metrics, manufacturing performance, deviations, complaints,
    stability data, and CAPA outcomes
  • Product wise issue identification and trend detection

Analytics, Trends & Cross Functional Insights

  • Realtime dashboards delivering trend intelligence across all registered products
  • Rolling and periodic reviews aligned with regulatory expectations
  • Verification of process consistency and performance stability
  • Assessment of the appropriateness of existing specifications

Enterprise Review, Compliance Oversight & Decision Support

  • Leadership visibility into product performance, compliance health, and emerging risks
  • Promotes transparency and continuous improvement in pharmaceutical quality management
  • Single platform consolidating all product review data for easy audit and inspection readiness

Key Benefits

Leadership visibility into product performance, compliance health, and emerging risks

Enables proactive decisions and sustained quality improvement

Promotes transparency and continuous improvement in pharmaceutical product quality management

Single platform consolidating all product review data

Business Benefits

Streamlines annual product quality reviews with automated data consolidation across all connected quality modules

Enhances early identification of product quality patterns through realtime dashboards and continuous monitoring

Eliminates manual data handling errors by replacing multisystem consolidation with a single integrated platform

Improves product and process quality by uncovering improvement opportunities through structured, data driven reviews

Strengthens regulatory submissions and inspections with traceable, well documented APQR evidence

Accelerates annual review cycles, allowing quality leaders to focus more on strategic improvement initiatives

70%

Reduction in APQR Prep Time

10–25%

Reduction in Batch Failure Rates Over Time

3× Faster

Product Quality Trend Identification

Days → Hours

Annual Review Cycle Duration

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.

Quality metrics, batch manufacturing performance, deviations, Out of Specification results, market complaints, stability data, CAPA outcomes, and change control data are consolidated from across the quality system.

Products including finished products, APIs, and export-only items are registered with relevant batch data, specifications, and review parameters  ensuring all products subject to regulatory review are captured.

Real-time dashboards and trend intelligence tools analyze performance data by product, batch, and parameter highlighting trending results, process drifts, and specification compliance rates.

Structured review and approval workflows with electronic signatures ensure PQR/APQR reports are reviewed, commented, and approved by designated quality and management personnel.

Yes. The module supports both periodic (annual) and rolling review formats, allowing organizations to conduct more frequent reviews for high-risk or high-volume products.

The module includes structured sections for findings summary, conclusions, recommendations, and action item assignments with tracking of action completion before report finalization.

Yes. Trend data and batch performance analysis within the module enable quality teams to evaluate whether current specifications remain appropriate or need revision.

Structured, data-driven PQR reports with complete source data traceability demonstrate a functioning pharmaceutical quality system a key inspection focus area for both FDA and MHRA.

The module generates product level PQR reports, batch performance summaries, trend analysis reports, management review presentations, and regulatory submission-ready annual quality review documents.

Yes. The PQR/APQR module is designed to comply with 21 CFR Part 11 and EU Annex 11 requirements. It supports electronic signatures, audit trails, secure user access, and data integrity controls, ensuring all review records are secure, traceable, and audit ready for regulatory inspections.