Skip to content Skip to footer
Menu Close
  • 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
Close
  • 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
Get in Touch
Analysis/Laboratory​ Modules

softLIMS

Reference Standards Management

Digitizes the complete lifecycle of reference standards registration, qualification documentation, controlled issuance, and usage tracking. Ensures traceability from receipt through analytical application with structured validity monitoring and storage oversight. By centralizing control and maintaining defensible records, it safeguards standard authenticity, strengthens data integrity, and reinforces regulatory compliance.  

Request Demo

Core Features

Centralized Repository for Reference & Working Standards

  • Unified tracking of reference, working, impurity & certified standards
  • Capture batch details, expiry, potency & qualification status
  • Barcode enabled identification for error free usage
  • Realtime visibility into available stock & validity

Controlled Issuance & Usage Log Management

  • Electronic issuance with quantity tracking & usage logging
  • Auto update of remaining quantities after each transaction
  • Attach supporting COAs, certificates & qualification documents
  • User level access control for secure material handling

Compliance, Audit Trails & Requalification Alerts

  • Time stamped audit trails for every standard lifecycle event
  • Automated alerts for expiry, requalification & low stock
  • Complete traceability from procurement to consumption
  • Inspection ready reports aligned with GMP and lab compliance norms

Key Benefits

Safeguards standard authenticity and analytical accuracy

Strengthens data integrity and regulatory compliance

Prevents use of expired reference standards through automated alerts

Complete traceability from receipt through analytical application

Business Benefits

Prevents the use of expired or invalid reference standards through controlled lifecycle management and automated enforcement

Improves reference standard accuracy by ensuring correct assay values, preventing systemic analytical errors

Provides complete traceability from receipt through analytical application for compliant investigations and audits

Strengthens laboratory data integrity with secure, version controlled documentation and controlled access

Reduces procurement and usage inefficiencies through optimized planning and consumption visibility

Enhances regulatory readiness by eliminating documentation gaps commonly cited during GLP and GMP inspections

100%

Container Level Traceability from Receipt to Disposal

10–15%

Reduction in Reference Standard Procurement Costs

100%

Container Level Traceability

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

Pharma is committed to helping you access trusted lab and pharmacy solutions, with expert help at every step of the way.

Primary reference standards (pharmacopoeial — IP, BP, USP, EP), secondary reference standards, in-house working reference standards, and impurity reference standards.

Procurement details, source information, assay values, certificate of analysis, and lot details are registered upon receipt creating the foundation for controlled reference standard management.

Each issuance from a reference standard lot is tracked to the specific container (vial/ampule) level, with quantity issued, date, analyst, and purpose recorded for complete consumption traceability.

Expiry dates are registered from the certificate of analysis. Automated notifications are sent before expiry, and expired standards are automatically restricted from further issuance.

Lot certificates are uploaded and linked to the reference standard record, with expiry tracking and renewal notifications ensuring current certificates are always available.

Stock solution preparation from reference standard lots is recorded within the module with quantities, concentrations, and expiry dates linked to the parent reference standard record.

Yes. Multiple active lots of the same reference standard can be managed concurrently, with separate status, expiry, and issuance tracking for each lot.

Formal termination workflows with documented justification and approval are required before a reference standard lot is closed ensuring complete and accurate stock records.

Complete traceability from receipt through every issuance to final termination is maintained linking each analytical result to the specific reference standard lot and container used.

Reports include reference standard master, index, usage history, stock card, destroy lot and vial quantity records, and stock solution usage reports.