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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

Vendor

Management System

Governs vendor qualification, performance monitoring, and risk oversight aligned with global GMP standards. Ensures evaluation and qualification of all vendors from product development through finished product manufacturing. Strengthens supply chain transparency, supports supplier audits, and ensures controlled documentation of all vendor related activities to safeguard product quality and regulatory compliance.

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Core Features

Centralized Vendor Qualification & Onboarding

  • Standardized vendor registration & qualification workflows
  • Workflow based approval of suppliers, manufacturers & service providers
  • Automated reminders for pending evaluations or renewals
  • Digitized vendor documents with version control

Vendor Approval & Audit Management

  • Centralized Approved Vendor List (AVL) with realtime status updates
  • Vendor approval, suspension, and disqualification tracking
  • Planning and scheduling of supplier audits
  • Digital capture of audit findings and observations
  • Audit closure tracking with compliance verification

Audit Ready Supplier Governance

  • Complete audit trail for every vendor interaction
  • Documented supplier certifications, SLAs & contracts
  • Realtime visibility into approved vendor lists
  • Inspection ready reporting for QA & regulatory teams

Key Benefits

Safeguards product quality through proactive vendor oversight

Strengthens supply chain transparency and integrity

Ensures regulatory compliance throughout entire supply chain

Transparent vendor performance monitoring across global operations

Business Benefits

Streamlines vendor qualification activities using automated workflows and structured digital checklists

Ensures uninterrupted supplier compliance through automated requalification scheduling and proactive alerts

Simplifies supplier audit preparation by centralizing all vendor documentation and maintaining a complete audit trail

Strengthens regulatory readiness by ensuring full supply chain compliance and eliminating gaps in supplier oversight

Enhances supply chain transparency and product quality through consistent vendor assessment and governance

50%

Faster Vendor Qualification

20–25%

Improvement in OnTime Supplier CAPA Closures

100%

Requalification Events Captured

30%

Reduction in SupplyChain Quality Failures

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.

Raw material suppliers, packaging material vendors, contract manufacturers, contract testing laboratories, service providers, and API suppliers all across the supply chain.

The AVL is maintained online with real-time status updates. New vendors go through a defined qualification workflow before approval, and the list auto-updates upon qualification decisions.

The system automatically generates requalification schedules based on defined intervals, sending advance email notifications to quality teams to initiate requalification activities on time.

Vendor evaluations are conducted using configurable checklists covering quality systems, regulatory compliance, documentation, delivery performance, and risk indicators.

Audit schedules are maintained and tracked online. Audit plans, findings, corrective action requirements, and closure documentation are all managed within the system.

Complete vendor qualification records, audit reports, AVL with approval history, and requalification evidence are instantly accessible supporting inspectors' queries on supply chain compliance.

Yes. Vendor-submitted documentation (certificates, licenses, quality agreements, test reports) can be stored, linked to vendor records, and tracked for validity and renewal.

Yes. The VMS module is designed to comply with 21 CFR Part 11 and EU Annex 11. It supports electronic signatures, audit trails, secure user access, and data integrity controls, ensuring all vendor-related records are secure, traceable, and audit-ready.

Yes. The system maintains complete vendor lifecycle history including qualification, evaluation, requalification, and audit records, along with detailed audit trails capturing all user actions and changes for full traceability.

Yes. The system supports cross-functional collaboration by allowing departments such as QA, QC, Procurement, and Regulatory to participate in vendor evaluation, approval, and review workflows with role-based access control.