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    • 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
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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

Stability Management

Automates stability study design, scheduling, pull management, testing allocation, and trend analysis. Manages complete stability testing programs with flexible storage conditions. Monitors chamber conditions, alerts for missed pulls, and tracks long-term, intermediate, and accelerated studies. Integrated statistical trending supports proactive quality decisions while ensuring alignment with global regulatory stability requirements.

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Core Features

End to End Stability Study Planning & Execution

  • Create stability protocols with automated study setup
  • Define storage conditions, time points & pull schedules
  • Auto generate study calendars & worklists
  • Real time tracking of sample pulls and testing status

Digital Stability Data Capture & Documentation

  • Electronic recording of stability test results
  • Attach supporting documents, chromatograms & COAs
  • Version controlled updates with reviewer/approver workflows
  • Seamless linkage with LIMS & sample management modules

Compliance, Trending & Regulatory Reporting

  • Automated trending of stability results over time
  • Alerting for out of trend (OOT) and out of spec (OOS) values
  • Audit trails for every stability activity and record
  • Inspection ready reports aligned with ICH Q1A(R2) guidelines

Key Benefits

Provides required stability data to regulatory authorities without delay

Integrated statistical trending for proactive quality decisions

Eliminates manual scheduling and tracking errors

Ensures alignment with global regulatory stability requirements

Reduces risk of missed stability pulls

Business Benefits

Ensures timely execution of all stability pulls through automated scheduling and controlled digital workflows

Streamlines stability study management with auto‑generated worksheets, centralized data, and integrated review processes

Prevents protocol deviations by eliminating manual scheduling errors and enforcing controlled, compliant execution

Improves regulatory submission readiness by ensuring complete, accurate, and on‑time stability data packages

Supports data driven decision making with built in statistical trending that helps evaluate product performance over time

Reduces the impact of stability failures through early detection of degradation trends and robust investigation support

99%+

On Schedule Stability Pull Compliance

$1M–$50M+

Cost Exposure Avoided From Stability Failures

60%

Reduction in Stability Study Management Effort

6–18 Months

Potential Shelf‑Life Extension With Trending

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.

The module supports long term, intermediate, and accelerated stability studies for finished products, APIs, drug substances, and in process materials all within a centralized and controlled system.

Stability protocols are created, reviewed, and approved through configurable multi level workflows with electronic signatures, ensuring proper governance before study initiation.

Based on the approved protocol, the system automatically generates pull schedules with defined time points, required tests, and analyst assignments, eliminating manual scheduling errors.

Test results are captured digitally with automatic calculations as per configured methods. Certificates of Analysis (COAs) are automatically generated for each pull upon completion and approval.

The system provides statistical analysis including trend plots, regression analysis, and shelf life projections aligned with ICH Q1E requirements, supporting regulatory submissions.

Automated alerts and reminders are sent before and after scheduled pull dates, supported by real time dashboards to ensure no pull is missed a key regulatory requirement.

Yes. The system supports multiple storage conditions (e.g., 25°C/60%RH, 30°C/65%RH, 40°C/75%RH) within a single protocol, with condition specific scheduling and tracking.

Reports include protocol summaries, pull schedules, COAs, quantity withdrawal summaries, schedule deviation reports, and statistical trend analysis outputs.

The module aligns with ICH Q1A–Q1F requirements for study design, scheduling, data analysis, and documentation, supporting global regulatory compliance.

Yes. The module supports electronic signatures, audit trails, secure user access, and data integrity controls, ensuring compliance with 21 CFR Part 11 and EU Annex 11 requirements.