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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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Operation Modules

Electronic Batch

Manufacturing Records

Transforms traditional paper based Batch Manufacturing Records into intelligent, interactive electronic records. Guides operators through each manufacturing step while ensuring every activity is executed according to validated procedures. Embeds process controls, real time validations, and automated calculations to eliminate manual documentation errors. Quality teams benefit from Review by Exception functionality deviations and abnormal results are highlighted instantly for faster batch review and release.

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Core Features

Intelligent Digital Batch Execution

  • Guided manufacturing workflows with GMP‑validated steps
  • Automated calculations to eliminate manual entry errors
  • Real‑time operator guidance with exception prompts
  • Integrated e‑signatures for stage-wise approvals

Automated Compliance & Review Efficiency

  • Review by exception for faster batch release cycles
  • Time-stamped audit trails for every data entry and action
  • Rule based checks to prevent deviations before they occur
  • Centralized access to batch records for QA review

Enhanced Accuracy & Right‑First‑Time Manufacturing

  • Auto verification of critical process parameters
  • Elimination of paper based documentation and transcription errors
  • Integrated equipment logbooks and usage tracking
  • Real time visibility into batch progress and discrepancies

Key Benefits

Eliminates manual documentation errors and paper records

Faster batch review and release — reduced inventory holding time

Accelerated product availability

Automates BMR and BPR review and approvals as a paperless solution

Strengthens data integrity, enhances traceability

Ensures full compliance with GMP and regulatory requirements

Enables Right First Time manufacturing

Business Benefits

Streamlines batch record review using exceptions based review and automated validation checks

Accelerates batch release decisions by replacing manual record handling with fully digital workflows

Eliminates documentation related errors through guided execution and real‑time data capture

Improves manufacturing reliability by reducing process variations and ensuring consistent batch execution

Reduces operational workload by digitizing compilation, review, and QA release activities across product lines

Strengthens data integrity and traceability while eliminating all paper‑based record storage and handling

50–70%

Reduction in Batch Record Review Time

$20K–$80K

Annual Savings from Eliminating Paper BMR Storage

2–5 Days Faster

Batch Release Cycle

30–50%

Reduction in Documentation‑Related Deviations

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

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.

The system presents operators with step-by-step instructions aligned to the approved BMR, requiring confirmation and sign-off at each step before proceeding preventing skipped or out-of-sequence activities.

Temperature range validations, weight calculations, yield computations, material quantity verifications, time checks, and concentration calculations are automated eliminating manual calculation errors.

Electronic signatures are required at all manufacturing steps and approval stages, with user ID, timestamp, and meaning of signature captured fully compliant with 21 CFR Part 11.

Yes. The system is browser-based and accessible from any LAN connected computer or approved device on the production floor  supporting flexible deployment without specialized hardware.

Operators can record deviations directly within the EBMR at the point of occurrence. These are flagged for QA review and can trigger linked deviation and CAPA records.

Real time batch data availability, Review by Exception, and electronic approvals eliminate the time needed to physically compile, route, and review paper batch records cutting review time by 50–70%

Yes. softBMR manages both BMR and BPR workflows within the same system, providing unified electronic governance of the complete batch lifecycle.

Every executed batch record is archived with complete step bystep execution data, material reconciliations, equipment usage, operator signatures, and deviation records providing full batch genealogy.

EBMR is designed to comply with 21 CFR Part 11 and EU Annex 11 requirements. It supports electronic signatures, secure user authentication, audit trails, and data integrity controls, ensuring all batch records are secure, traceable, and audit-ready.

Yes. EBMR integrates seamlessly with Deviation, CAPA, and other QMS modules, enabling automatic linkage of manufacturing events to quality processes, ensuring end to end traceability and streamlined compliance management.