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Company description

Pharmasoft develops compliance-focused software for pharmaceutical manufacturing and laboratory operations. The company offers a suite of modular applications covering quality management, manufacturing operations, and laboratory analysis, designed to help pharma organisations maintain regulatory compliance, standardise workflows, and replace paper-based processes with auditable electronic systems.

Its product portfolio is organised across three functional areas — Quality, Operations, and Analysis — each comprising multiple dedicated modules that can be deployed to address specific compliance and operational requirements within a pharmaceutical facility.

Quality Management Modules (softQMS / softDMS)

• softQMS – Change Control: Centralises risk-assessed change control processes with approved, compliant workflows.
• softQMS – Incidents Management: Provides structured documentation and assessment of quality events.
• softDMS – Document Management System: Controls document lifecycles with a focus on compliance, security, and consistency.
• softQMS – Deviation Management: Standardises the capture, investigation, and resolution of operational deviations.
• softQMS – Market Complaints Management: Manages complaint intake, investigation, compliance reporting, and risk control.
• Learning / Training Management System: Tracks employee training, certification, and compliance readiness automatically.
• softQMS – Corrective and Preventive Action (CAPA): Manages CAPA processes to support accountability, compliance, and continuous improvement.
• softQMS – Investigation Management: Handles investigations with root-cause analysis and integration with CAPA workflows.
• Electronic Validation Management System: Digitises validation activities with compliance tracking, traceability, and timely execution.
• softQMS – Audit Management: Supports audit planning and execution within a compliant framework.
• VMS – Vendor Management System: Manages vendor qualification and ongoing compliance.
• QRM – Quality Risk Management: Provides tools for structured quality risk assessment.
• PQR / APQR – Annual Product Quality Review: Facilitates periodic product quality review processes.
• EDMS – Electronic Document Management System: Manages electronic documents with version control and compliance features.

Operations Modules (softBMR / eCalPM / MES / E-Log)

• softBMR – Electronic Batch Manufacturing Records (EBMR): Converts batch records into electronic, error-reduced workflows.
• eCalPM – Calibrations: Manages the full instrument calibration lifecycle with compliance and traceability.
• eCalPM – Breakdown Maintenance: Streamlines equipment repair processes with tracking, root-cause analysis, and compliance documentation.
• MES – Manufacturing Execution System: Connects production systems and provides real-time operational insights across the manufacturing floor.
• eCalPM – Preventive Maintenance: Supports proactive asset maintenance through scheduling and analytics.
• E-Log – Electronic Equipment Logbook: Replaces paper-based equipment logbooks with secure, compliant electronic audit trails.
• eCalPM – Annual Maintenance Contract (AMC) Management: Manages maintenance contracts with tracking, alerts, and compliance oversight.

Analysis and Laboratory Modules (softLIMS)

• LIMS Masters – Specifications and Standard Test Procedures: Centralises laboratory master data with governance and compliance controls.
• softLIMS – Instrument Management: Tracks instrument lifecycle with compliance enforcement and system integration.
• softLIMS – Working Standards Management: Manages working standards with traceability, expiry alerts, and compliance.
• softLIMS – Sample Management: Manages the full sample lifecycle including tracking, compliance, and data integrity.
• softLIMS – Solutions Management: Digitises solution preparation with validation, tracking, and compliance documentation.
• softLIMS – Column Management: Tracks chromatography column lifecycle with alerts and compliance records.
• softLIMS – Stability Management: Automates stability study tracking, scheduling, alerts, and trend analysis.
• softLIMS – Reference Standards Management: Manages reference standards with traceability, validity tracking, and compliance.
• softLIMS – Control Samples Management: Handles sample retention with traceability, alerts, and compliance records.
• softLIMS – Water Management: Monitors and manages water quality data within laboratory environments.
• Environmental Management System (Microbiology): Supports environmental monitoring within microbiology laboratory settings.
• softLIMS – Chemical Management: Tracks chemical inventory and usage with compliance controls.
• softLIMS – Label Management: Manages laboratory labelling processes within a compliant framework.

Pharmasoft's modular architecture allows pharmaceutical organisations to adopt individual solutions or combine modules across quality, operations, and laboratory functions, supporting end-to-end digital compliance across a manufacturing site.

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Software attributed to Pharmasoft

• MESView
• softBMRView
• PQR/APQRView
• eCalPM – CalibrationsView
• eCalPM – Preventive MaintenanceView
• eCalPM – Breakdown MaintenanceView
• E-LogView

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