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Email: info@laurusis.com

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  • Increased Regulatory audits to ensure quality and compliance.
  • Warning letters and import restrictions. Key reasons:
    • Data documentation discipline,
    • Data integrity,
    • Due process failures,
    • Hygiene control,
    • Lack of procedural awareness
  • Companies fail in clearing surprise Regulatory Audits.

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  • Timely equipment calibration
  • Timely raw material re-testing
  • Dispensing material using FEFO and FIFO rule
  • Maintenance and manufacturing date conflicts
  • Master and Batch Record maintenance
  • Deviation documentation challenge
  • Data documentation discipline

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  • Adopting modern technology
  • Network enabling of equipment
  • Integration with ERP/SAP
  • Equipment data capture inadequacy
  • 21CFR11 and 21CFR211 Compliance

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