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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

Control Samples Management

Ensures systematic management of retention, reserve, and control samples with full traceability from batch linkage to storage location and reconciliation logs. Retest due dates are generated automatically. Supports audit readiness, recall investigations, and regulatory verification requirements with structured documentation control.

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Core Features

Centralized Control Sample Inventory & Tracking

  • Maintain repository of primary, secondary & working control samples
  • Capture batch number, expiry, potency & storage conditions
  • Barcode enabled identification for accurate sample retrieval
  • Realtime visibility into availability and sample lifecycle status

Controlled Issuance, Usage Logging & Reservations

  • Electronic issuance with quantity, batch and analyst capture
  • Automated updating of remaining control sample quantity
  • Reserve samples for specific tests, batches or analysts
  • Attach COAs, qualification data & handling instructions

Compliance, Stability & Audit Readiness

  • Automated alerts for expiry, retesting & requalification
  • Complete time stamped audit trails for all sample events
  • Linkage to OOS/OOT workflows and LIMS test execution
  • Inspection ready reports aligned with GMP & QC lab expectations

Key Benefits

Enables rapid recall investigation support

Ensures regulatory verification requirements are met

Automated retest notifications prevent missed retests

Complete traceability from batch to storage location to final disposition

Business Benefits

Enables rapid recall readiness by providing instant access to sample location, history, and disposition

Ensures timely completion of all retest activities through automated scheduling and controlled notifications

Strengthens regulatory compliance by eliminating gaps in control‑sample documentation and management practices

Provides complete batch to sample traceability to support effective investigations and post‑market surveillance

Streamlines retain sample administration with centralized digital tracking instead of manual registers

Reduces operational risk by ensuring samples are stored, tracked, and managed according to compliant retention protocols

Hours → Days Saved

Faster Recall Response Time

$500K–$2M+

Cost Avoided Through Rapid Recall Coordination

100%

On Schedule Retest Compliance

50–60%

Reduction in Control Sample 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.

Each control sample registration is linked to the corresponding production batch, providing direct traceability from product batch to stored control sample essential for recall investigations.

Storage location details (room, refrigerator, rack, shelf) are registered for each control sample, with the ability to update and track location changes throughout the retention period.

Retest due dates are generated automatically based on defined retest intervals. Automated notifications are sent to responsible personnel as due dates approach, preventing missed retests.

Complete traceability from batch to stored sample location enables rapid identification and retrieval of control samples for investigation during product recall or regulatory inquiry situations.

Separate workflows manage pass and fail control samples ensuring appropriate disposition with full documentation for each outcome.

Destruction workflows require documented authorization with electronic signatures, reason for destruction, and complete destruction records maintaining regulatory compliance for controlled sample disposition.

Auto updating functionality ensures control sample records reflect current status, retest results, and location information eliminating the manual reconciliation effort of paper based systems.

Retention period configurations are set per product type and regulatory market requirements ensuring samples are retained for the required duration and triggering disposition reviews at the appropriate time.

Reports include control sample status by product and batch, retest schedule, location inventory, destruction records, reconciliation logs, and regulatory retention compliance reports.