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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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Quality Modules

Document

Management System

Establishes authoritative, end to end control over regulated documentation across its entire lifecycle from creation and review through approval, issuance, reconciliation, and archival. Governs SOPs, specifications, protocols, formats, logbooks, batch manufacturing and packaging records within a secure, inspection ready environment. Integrated with Training Management and Change Control for enterprise wide consistency.

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Core Features

Document Lifecycle Automation

  • Streamlined document initiation, review & multi level approval
  • 21 CFR Part 11 compliant electronic signatures
  • Automated revision control & scheduled reminders
  • Centralized archival with complete version governance

Collaboration & Controlled Distribution

  • Reviewer / approver routing with configurable workflows
  • Auto update of master list & linked documents
  • Controlled print issuance & watermarking
  • Role based access with secure distribution mechanisms

Compliance & Inspection Readiness

  • Built in audit trails for every document action
  • Validation ready, secure document architecture
  • Realtime status tracking for drafts, reviews & approvals
  • Regulatory compliant document retention & integrity controls

Key Benefits

Automates document review and approvals as a paperless solution

Email alerts for revision dues and overdues

Online initiator, reviewer, and approver selection

Auto updating of Master Lists

Users can review documents anytime and from anywhere

Reduces compliance costs while improving process and product quality

Right documentation available at the right time

Business Benefits

Reduces document review and approval cycle time by up to 60% through automated routing and electronic approvals

Cuts document retrieval time from hours to under 30 seconds using fast digital search

Eliminates paper, printing, and physical storage costs, saving organizations $50,000–$150,000 annually

Ensures realtime version control, eliminating access to obsolete documents entirely

Assembles audit ready document packages in under 5 minutes instead of several hours

Reduces regulatory findings by up to 35% while improving compliance and overall quality

60%

Faster Review & Approval Cycles

$50K–$150K

Annual Cost Savings

<30 sec

Document Retrieval Time

35%

Reduction in Regulatory Findings

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.

softDMS manages SOPs, work instructions, protocols, specifications, STPs, formats, batch records, packing records, logbooks, and other controlled documents within a single system.

Every revision generates a new version with a complete audit trail. Superseded versions are automatically archived and blocked from use, ensuring only current, approved versions are accessible.

Yes. softDMS is web based, allowing authorized users to review, comment, and electronically approve documents from any location, supporting multi-site operations.

Integration with the LMS module automatically assigns training to affected users whenever a revised document is approved and issued.

Automated reminder notifications are sent before and after due dates, along with escalation alerts to supervisors for overdue revisions.

The system uses role based access control (RBAC), audit trails, and electronic signatures compliant with 21 CFR Part 11 and EU Annex 11 to ensure data integrity, security, and compliance.

The system manages issuance and return of documents, formats, and logbooks with unique identification, controlled print options, issuance logs, and return tracking. All transactions are recorded in audit trails to ensure traceability and accountability.

Controlled distribution is handled electronically with department-wise access, print controls, and acknowledgment tracking. Each distribution activity is recorded in the audit trail.

The Master Document List is auto updated with every document approval, revision, issuance, return, or archival activity, eliminating manual updates

Advanced search features including full text search, document code, department, and status filters enable instant retrieval of documents, supporting efficient regulatory inspections.