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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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Analysis/Laboratory​ Modules

softLIMS

Working Standards Management

Digitizes the preparation, qualification, controlled issuance, and usage logging of working standards within a structured, compliant framework. Maintains full traceability from reference standard linkage through analytical application. Automated validity and expiry alerts prevent unintended use, safeguarding analytical accuracy, data integrity, and regulatory alignment across laboratory operations.

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Core Features

Centralized Working Standards Repository

  • Maintain complete inventory of all working standards
  • Capture potency, batch number, expiry & qualification details
  • Barcode-based tracking for accurate identification
  • Real-time visibility into available stock & validity status

Controlled Issuance & Consumption Tracking

  • Electronic issuance with quantity and usage logging
  • Auto‑update of balance quantity after each transaction
  • Attach COAs, qualification documents & reference certificates
  • Access-controlled handling for authorized personnel only

Compliance, Requalification & Audit Traceability

  • Automated alerts for expiry, requalification & low stock levels
  • Full audit trails for each event in the standard’s lifecycle
  • Seamless linkage with LIMS tests & sample workflows
  • Inspection-ready records aligned with GMP expectations

Key Benefits

Prevents unintended use of expired or invalid working standards

Full traceability from reference standard through analytical application

Safeguards analytical accuracy and data integrity

Reduces risk of analytical failures due to standard-related issues

Business Benefits

Reduces analytical failures by enforcing controlled qualification, issuance, and verification of all working standards

Prevents use of expired or unqualified working standards through automated tracking and preparation controls

Ensures complete metrological traceability from primary reference standards through working standards to analytical results

Streamlines working‑standard administration with digital workflows, centralized records, and standardized documentation

Optimizes reagent and working‑standard usage with real‑time visibility into stock levels and consumption

Strengthens analytical accuracy and compliance by eliminating standard‑related sources of data integrity issues

25%

Reduction in Working‑Standard Analytical Failures

10–20%

Reduction in Reagent Wastage

10–15%

Avoidable OOS Root Causes Prevented

50%

Reduction in Working‑Standard Admin Effort

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

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

Working standards are prepared from reference standards through a qualification process. The LIMS maintains bi-directional traceability — every working standard lot is linked to its parent reference standard, preserving the analytical traceability chain.

Qualification involves standardization against the parent reference standard. Results are recorded in the system with approval workflow — a working standard is only released for analytical use after passing qualification.

Issuance is managed digitally with quantity, date, analyst, and intended test batch recorded. The system ensures only qualified, in-date working standards are available for issuance.

Automated expiry and use-before alerts notify analysts and supervisors before dates are reached. Expired working standards are automatically blocked from issuance.

Yes. The module supports internal lot creation (in-house preparation) and external lot registration (commercially procured working standards), both managed within the same framework.

Real-time stock balance is maintained per working standard lot, with automatic updates on each issuance and vial preparation event — providing accurate consumption data for planning.

Vial preparation records capture analyst, date, quantities, concentrations, and labels — generating a complete preparation record linked to the working standard lot.

The traceability chain from pharmacopoeial reference standard through secondary reference to working standard is maintained within the system — meeting GLP requirements for metrological traceability.

Reports include WS vial preparation, usage report, destruction records, stock card, and COA — providing complete documentation for audit and regulatory review.

Complete audit trails, electronic signatures, and version-controlled records for all working standard activities ensure that analytical results are traceable to authenticated, validated standards — a fundamental data integrity requirement.