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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

LIMS Masters – Specifications &

Standard Test Procedures

Serves as the foundational governance layer of the laboratory ecosystem. Centralizes master data for materials, specifications, test methods, sampling plans, and workflows. Role based controls, structured approval workflows, and audit trails ensure that any master updates are controlled, traceable, and compliant. This standardized framework minimizes data inconsistencies and safeguards analytical reliability across sites.

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Core Features

Centralized Master Data & Structured Governance

  • Unified master data repository for materials and products
  • Specification management with version control and archival
  • Standard Test Procedures (STP) and test method governance
  • Sampling plan creation and management
  • Workflow configuration for lab processes and method adherence

Controlled Access, Approvals & Master Traceability

  • Role based access controls ensuring secure master data handling
  • Structured approval workflows for creating and updating master records
  • Complete audit trails capturing every change, review, and authorization
  • Multi‑site consistency controls for harmonized specifications

Enterprise Reliability, Compliance & Data Integrity

  • Minimizes data inconsistencies across lab operations and test workflows
  • Safeguards analytical reliability and standardization across all sites
  • Provides a single source of truth for specifications, methods, and sampling plans
  • Ensures compliant, traceable, and controlled updates across the laboratory ecosystem

Key Benefits

Minimizes data inconsistencies across laboratory operations

Safeguards analytical reliability across sites

Single source of truth for all specifications and test methods

Ensures controlled, traceable, and compliant master updates

Business Benefits

Ensures consistent specifications across all sites by centralizing creation, updates, and governance

Streamlines specification updates using controlled digital workflows and standardized approval steps

Prevents analytical discrepancies by providing a single source of truth for all test methods and controlled documents

Maintains full version control to avoid misuse of outdated or superseded specifications during lab operations

Improves regulatory readiness with complete audit trails and controlled access for all specification changes

Enhances analytical reliability by minimizing data inconsistencies and ensuring traceable, compliant master updates

50%

Reduction in Specification Update Cycle Time

35%

Reduction in Specification‑Related Audit Findings

10–20%

Avoidable OOS Results Prevented

100%

Version‑Controlled Specifications

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.

Material specifications (raw materials, in process, finished products, packing), standard test procedures (STPs), test methods, sampling plans, workflow configurations, and analytical parameters.

Every specification or STP revision generates a new version with full audit trail. Previous versions are archived, and only the current approved version is available for active testing.

Specification revisions automatically update the active testing worksheets in the Sample Manager module and can trigger training assignments for analysts affected by the change.

Yes. Specifications can be configured to reference IP, BP, USP, or in house test methods, with appropriate acceptance limits and test procedures for each standard.

Sampling plans are configured by material type, batch size, and sampling requirement. They are version-controlled and linked to testing workflows to ensure correct sampling for every analysis.

Role-based access ensures that only authorized users can create, revise, or approve specifications and STPs  protecting the integrity of laboratory master data.

A centralized master data repository ensures all sites use the same approved specifications and test methods  eliminating discrepancies that arise from decentralized, site-specific document management.

Structured multi-level approval workflows with electronic signatures are required for all specification and STP changes ensuring appropriate review and authorization before changes take effect.

Every creation, revision, approval, and archival event is captured with user ID, timestamp, reason, and electronic signature  providing a complete, immutable audit trail for all master data.

Yes. Specification parameters and acceptance limits in the master data feed directly into COA report templates in the Sample Manager module ensuring accurate, consistent COA generation.