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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
  • Contact Us
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Quality Modules

Electronic

Validation Management system

Digitizes and governs the end to end validation lifecycle across systems, equipment, processes, cleaning, analytical methods, and other regulated validation activities. Aligned with risk-based methodologies and global regulatory expectations. Centralizes protocols, execution records, approvals, and traceability within a controlled digital framework. Ensures timely compliance and eliminates missed validation timelines.

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Core Features

Electronic Validation Planning & Structured Documentation

  • Electronic creation and management of validation protocols with standardized templates
  • Centralized repository for protocols, test scripts, and validation documents
  • Version-controlled documentation with full audit trails
  • Configurable workflows for protocol preparation, review, and approval

Execution, Review & Lifecycle Traceability

  • Step-by-step electronic execution of validation activities with real-time data capture
  • Mandatory electronic signatures for execution, review, and approvals (21 CFR Part 11 compliant)
  • Automated alerts and notifications for pending actions and due dates
  • Complete lifecycle traceability from protocol creation to final report approval

Compliance Oversight & Performance Intelligence

  • Ensures data integrity and regulatory compliance with audit-ready electronic records
  • Centralized visibility of validation status across all stages (planned, in-progress, completed)
  • Real-time dashboards for execution progress, review status, and overdue activities
  • Strengthens inspection readiness with complete, traceable validation documentation

Key Benefits

Strengthens regulatory defensibility

Enhances inspection readiness

Accelerates compliant deployment and lifecycle maintenance

Ensures timely compliance with GMP validation requirements

Reduces manual errors through electronic execution

Scalable to plant or enterprise-wide installation

Business Benefits

Ensures on schedule validation delivery through structured workflows and automated timeline management

Streamlines validation documentation using standardized digital templates and centralized record controls

Accelerates audit and inspection readiness with instantly retrievable validation evidence and complete traceability

Reduces remediation exposure by eliminating gaps that commonly trigger validation related compliance actions

Speeds deployment of validated systems through preapproved protocol structures and parallel review processes

Supports scalable validation management across equipment, utilities, and computerized systems at site or enterprise level

100%

OnSchedule Validation Completion

$500K–$5M+

Cost Avoided from Validation‑Related Remediation

55%

Reduction in Documentation Effort

30%

Faster Validated System Deployment

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.

Equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, computer system validation (CSV), analytical method validation, utility qualification, and facility validation all within a single system.

The EVAL module manages the complete validation lifecycle from planning, protocol preparation, execution, deviation handling, and approval. It ensures all validation activities are interconnected and aligned with regulatory expectations throughout the equipment and process lifecycle.

Email notifications are sent to responsible personnel and supervisors at configurable alert dates well before the validation due date ensuring zero missed timelines.

Protocols, deviations during execution, results, and approval signatures are all captured within the system eliminating paper-based execution binders and improving traceability.

Yes. The module follows GAMP 5 risk based validation principles and all electronic records and signatures comply with 21 CFR Part 11 and EU Annex 11 requirements.

Deviations observed during validation execution are documented within the validation record, assessed for impact, and linked to the investigation and CAPA modules if required.

Yes. The system is scalable to plant or enterprise wide installation, supporting multi-site validation management with centralized dashboards and site-specific records.

Revalidation triggers are automatically generated based on defined intervals, post change events, or system alerts  ensuring periodic review requirements are never missed.

Dashboards show validation status (planned, in progress, completed, overdue) by equipment category, department, and time period, with auto generated PDF MIS reports.

All validation protocols, execution records, approval signatures and deviation documentation are digitally stored and retrievable demonstrating full lifecycle validation compliance to inspectors.