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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
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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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Operations Modules

eCalPM

Calibrations

Controls the complete lifecycle of instruments and measuring devices, from scheduling and execution to evaluation and certification. Automated alerts, tolerance verification, and electronic calibration certificates ensure consistent measurement accuracy and compliance with regulatory standards. Maintains a centralized instrument master database with full traceability of calibration history, deviations, and corrective actions. Integrated trend analysis and performance monitoring help identify recurring issues and improve long-term instrument reliability.

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Core Features

Automated Calibration Scheduling & Tracking

  • Centralized calendar for all calibration activities
  • Auto generated due, overdue & upcoming notifications
  • Equipment categorization based on criticality & usage
  • Real time tracking of calibration status across all assets

Electronic Calibration Records & Certificates

  • Digital calibration worksheets with step-by-step data capture
  • Secure e‑signatures compliant with 21 CFR Part 11
  • Auto attachment of calibration certificates & reports
  • Complete audit trail for every record modification

Performance Analysis & Compliance Controls

  • Trend analysis to identify recurring equipment deviations
  • Risk-based calibration frequency optimization
  • Integrated CAPA linkage for out-of-tolerance results
  • Inspection ready logs aligned with GxP and ISO standards

Key Benefits

Ensures timely calibration without missing any due date

Strengthens data integrity and eliminates manual documentation

Enhances audit readiness

Identifies recurring issues through trend analysis

Supports consistent product quality through reliable measurement accuracy

Business Benefits

Ensures timely and reliable calibration execution through automated scheduling and controlled workflows

Streamlines calibration administration with digital worksheets, standardized records, and centralized documentation

Prevents quality risks and product failures by eliminating the use of out‑of‑calibration instruments

Reduces compliance exposure with complete traceability, audit‑ready history, and defensible calibration evidence

Enhances operational efficiency by eliminating manual record handling and simplifying audit preparation

Improves long‑term instrument reliability through proactive trend analysis and early identification of performance drift

99%+

On‑Time Calibration Compliance

15–25%

Reduction in Measurement‑Related OOS Investigations

65%

Reduction in Calibration Administration Effort

100–300 Hours

Annual Time Saved per Facility

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.

All measuring and test equipment (M&TE) including balances, pH meters, thermometers, pressure gauges, flow meters, spectrophotometers, dissolved oxygen meters, and process control instruments.

The system tracks calibration due dates in real time. Overdue instruments are flagged with visual indicators, and integration with other modules prevents their selection for critical activities.

Upon completion and approval of a calibration activity, the system automatically generates a calibration certificate and label with instrument details, results, calibration date, and next due date.

Calibration data is entered into the system with defined acceptance tolerances. The system automatically evaluates results against tolerances and flags pass/fail status eliminating manual calculation errors.

Email notifications are sent at configurable intervals (e.g., 30, 15, 7 days before due date) to responsible personnel and supervisors ensuring ample time to schedule and complete calibrations.

Yes. Both internal and external calibration workflows are supported, with documentation, certificate storage, and recall tracking for externally calibrated instruments.

All calibration records, worksheets, and certificates are captured with electronic signatures, timestamps, and complete audit trails fully aligned with 21 CFR Part 11 and EU Annex 11.

Yes. Calibration worksheets are configured per instrument category with required test points, units, acceptance criteria, and methodology ensuring consistent calibration execution

Reports include calibration schedule summary, overdue instrument list, calibration trend by instrument, certificate index, and performance dashboards available as auto generated PDF outputs.

The system maintains records of calibration standards and reference instruments used during calibration, including their validity and traceability to national or international standards, ensuring measurement accuracy and compliance with regulatory requirements.