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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

Column Management

Provides a complete solution for HPLC/GC column lifecycle management. Handles column application registration, individual column IDs, assignment to product or material testing, system suitability parameters, and GLP compliance. Automates injection count tracking with notifications as maximum column usage is approached.

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Core Features

Centralized Column Inventory & Lifecycle Tracking

  • Maintain complete inventory of HPLC, GC & specialty columns
  • Track serial numbers, purchase details, usage hours & shelf life
  • Barcodeenabled identification for quick retrieval
  • Realtime visibility into column availability & condition

Usage Logging, Assignment & Performance Monitoring

  • Electronic logbooks for each injection, run or analysis
  • Track column assignment to analysts, instruments & methods
  • Monitor efficiency, retention time & performance trends
  • Auto flag performance drops or column health deviations

Compliance, Qualification & Audit Readiness

  • Complete audit trails for every column activity
  • Alerts for column qualification, expiry & usage limits
  • Secure document storage for COAs & performance certificates
  • Inspection ready reporting aligned with GMP and QC standards

Key Benefits

Eliminates manual column tracking and injection count monitoring

Ensures columns are qualified before use

Prevents use of columns exceeding maximum injection count

Complete GLP compliance for column management

Business Benefits

Prevents the use of overused or invalid chromatographic columns through controlled injection count monitoring and qualification rules

Reduces analytical failures by enforcing proper column suitability, lifecycle governance, and standardized usage controls

Improves column procurement planning by eliminating premature replacements and ensuring optimized lifecycle utilization

Ensures complete GLP traceability with full documentation of column issuance, use history, and analytical application

Strengthens audit and inspection readiness by eliminating gaps in column documentation that often trigger observations

Eliminates manual tracking with digital monitoring, automated status updates, and controlled column‑usage workflows

4–8 Hours

Analytical Run Rework Avoided per Invalid Column Event

$500–$3,000

Savings per Prevented Premature Column Replacement

30%

Reduction in Column Related Analytical Failures

100%

Traceability Across Entire Column Lifecycle

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.

HPLC columns (C18, C8, Phenyl, CN, amino, etc.), GC columns, and other chromatographic columns each registered with complete technical specifications.

Injection counts are recorded for each column use event. Automated notifications are sent as the maximum injection limit approaches, enabling timely column evaluation or replacement before exceeding limits.

Column qualification protocols including system suitability tests, theoretical plate counts, tailing factors, and resolution criteria are defined and evaluated columns are only released for use after passing qualification.

System suitability parameters (theoretical plates, USP tailing, resolution, RSD) are defined per column application and method. Acceptance criteria are evaluated at each column use to ensure analytical reliability.

Yes. Each individual column has a unique ID and separate registration allowing individual injection count tracking, qualification history, and usage records for each physical column.

Column regeneration events are logged within the system, and re qualification requirements are triggered after regeneration ensuring columns are revalidated before returning to routine use.

The system flags the column as expired and blocks its selection for further test assignments — preventing the use of over-used columns that may compromise chromatographic performance.

Complete documentation of column identity, qualification, system suitability, usage, regeneration, and destruction all with electronic signatures and audit trails meets GLP requirements for column management records.

Yes. Each test execution records the specific column used, linking analytical results to the column's qualification and system suitability status at the time of analysis.

Reports include column index, usage history, qualification records, regeneration log, destruction records, and column type summary supporting laboratory management review and regulatory audits.