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Digi Pharma Transformation

          In regulated industries like pharmaceuticals, biotechnology, and sterile manufacturing, validation ensures that facilities, systems, and equipment consistently operate within defined limits, delivering products that meet quality, safety, and regulatory requirements.

        All automation solutions are 21 CFR Part 11 compliant, This ensures your automation system meets global USFDA, EMA, and WHO regulatory expectations. SVU Enterprises specializes in System Upgrades & Integration

  • PLC & HMI Upgrades: Migration from outdated platforms (like Siemens S5, Allen-Bradley legacy controllers, CP600 panels) to modern, compliant systems.
  • System Integration: Linking multiple utilities and equipment (e.g., purified water, WFI, HVAC, reactors) into a single SCADA for centralized monitoring.
  • Data Migration & Backup: Secure transition of historical data during upgrades without loss of integrity.
  • Audit Trails: Automatic, tamper-proof recording of all actions (start, stop, alarms, setpoint changes).
  • Access Control: Role-based access ensuring operators, supervisors, and administrators have defined privileges.
  • Secure Data Storage: Encrypted databases with redundancy for disaster recovery.
  • Electronic Records Management: Ensuring compliance with 21 CFR Part 11 and EU Annex 11 requirements.
  • Recipe Management & Control: Standardized, validated recipes to eliminate operator errors.
  • Automated Batch Reports: Secure, electronic batch records with timestamps, alarms, and operator actions.
  • CFR 21 Part 11 Compliant Electronic Signatures: Approval workflows integrated into batch execution.
  • Scalability: Supporting small-scale pilot batches to large-scale commercial manufacturing.

Our batch automation solutions enhance efficiency, reduce manual intervention, and ensure full traceability, making them ideal for pharmaceutical and biotech environments.

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  • Secure Data Storage: Encrypted databases with redundancy for disaster recovery.
  • Electronic Records Management: Ensuring compliance with 21 CFR Part 11 and EU Annex 11 requirements.
  • Recipe Management & Control: Standardized, validated recipes to eliminate operator errors.
  • Automated Batch Reports: Secure, electronic batch records with timestamps, alarms, and operator actions.
  • CFR 21 Part 11 Compliant Electronic Signatures: Approval workflows integrated into batch execution.
  • Scalability: Supporting small-scale pilot batches to large-scale commercial manufacturing.

Our batch automation solutions enhance efficiency, reduce manual intervention, and ensure full traceability, making them ideal for pharmaceutical and biotech environments.

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