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Electronic Document

Management System

Extends document governance to cover electronic logbooks, batch manufacturing records, and packaging records within a fully controlled, inspection ready digital framework. Ensures all controlled document types are governed with electronic signatures, version control, and complete audit traceability. Supports compliance across all regulated manufacturing documentation types.

Core Features

Controlled Documentation & Structured Governance

  • Governance of SOPs, specifications, protocols, and controlled formats
  • Centralized management of electronic logbooks
  • Batch manufacturing and packaging record governance
  • Version control with archival of superseded documents

Record Control, Traceability & Secure Distribution

  • Tamper proof audit trails for all document actions and revisions
  • Controlled access and distribution based on user roles
  • Integration with other QMS modules for end to end traceability
  • Standardized documentation templates supporting global regulations

Enterprise Compliance & Digital Inspection Readiness

  • Full lifecycle governance across all regulated documentation categories
  • Eliminates paper based records through complete digital enablement
  • Strengthens compliance and inspection readiness with audit ready records
  • Sustains regulatory alignment across global manufacturing operations

Key Benefits

Full lifecycle governance of all regulated documentation types

Eliminates paper based records across all document categories

Sustained compliance across global operations

Tamper proof audit trails for all controlled records

Business Benefits

Eliminates transcription and manual entry errors through structured electronic batch record workflows

Streamlines batch record review with instant search, exceptions based review, and automated validation checks

Reduces paper dependency and storage overhead by fully digitizing controlled batch documentation

Strengthens data integrity by replacing vulnerable paper processes with secure, audit ready electronic records

Enables instant access to production records, supporting faster investigations and inspection responses

Ensures complete lifecycle governance for all regulated documents across global manufacturing operations

70%

Reduction in Batch Record Review Time

$50K–$500K+

Cost Avoided per Prevented Batch Rejection

$30K–$100K+

Annual Savings from Eliminated Paper Handling

<60 sec

Record Retrieval Time

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.

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.

Equipment usage logs, cleaning logs, calibration logs, maintenance logs, sanitization records, and operational parameter logs any log required by GMP for equipment used in regulated manufacturing.

Real-time equipment status (Cleaned / Under Maintenance / Ready for Use / In Use) is visible to all authorized users, preventing equipment from being used in an unclean or uncertified state

Every log entry is authenticated with the user's credentials, automatic timestamp, and electronic signature creating an immutable, 21 CFR Part 11 compliant audit trail.

Yes. Log forms are fully configurable per equipment category and approved SOPs, ensuring each log captures the specific fields and data required for that equipment type.

Integration with EBMR and MES enables automatic capture of batch numbers, product names, lot numbers, and equipment operating times eliminating manual cross-referencing between batch records and equipment logs.

All logs are searchable by equipment, date range, product, operator, and status enabling any log record to be retrieved in seconds during inspector queries.

Yes. Complete equipment history including all usage, cleaning, maintenance, and calibration events is viewable in chronological order with full detail for any time period.

Mandatory fields and approval workflows prevent entry submission without required data. Automated alerts notify supervisors of pending or overdue log entries.

Yes. Logs can be viewed, printed, and exported to multiple file formats as required for batch record compilation, customer audits, or regulatory submissions.

The module directly addresses 21 CFR 211.182 requirements for equipment cleaning and use logs by maintaining complete, authenticated, tamper proof electronic records for every equipment operation.