Electronic Data Security with Pharmaceutical Grade Washers and Sterilizers

Olivier Van Houtte
Product Manager, Life Sciences Washing Systems

Managing electronic data, complying with evolving regulatory requirements and reducing paper records can be a daunting task for pharmaceutical manufacturers. It is now possible to easily manage critical electronic data related to production batches, equipment status and user actions. New technologies allow for transferring electronic data to a centralized SCADA system or developing stand-alone Electronic Data Management platforms. Solutions have been developed, tested and documented in accordance with GAMP 5 guidelines and provide the capability for complying with FDA (21 CFR Part 11) and European (Annex 11) regulations. The packages allow users to configure a comprehensive, yet cost effective system to manage vital electronic data using; Audit Trail, Password Security, E-Signatures, Data Archiving and Batch Data reporting.

Electronic Data Security Base Package (Figure 1)

Configured for users who have their own centralized data archiving and reporting capability.

The system includes:

  • Audit trail includes user identification, time and date for initiation of cycle, cycle abort, cycle parameter changes, alarm acknowledgments, unsuccessful login login/access attempts, etc. Audit trail is viewable from the HMI.
  • Local memory card for temporary data storage of audit trail and batch cycle data
  • Ethernet port: Batch data and audit trail can be exported to a customer supplied control system in a transportable format. Audit trail is transferred in CSV format. Data registers can also be read from the PLC via Ethernet
  • Password Protection: password protection features including unique access levels, aging, alpha numeric requirements, automatic log-out, etc.
  • E-signature: E-signature for final batch verification/acceptance is available

Electronic Data Security Base PackageElectronic Data Security Base Package

Figure 1 – Electronic Data Security Base Package

Electronic Data Security with Data Archiving and Enhanced Batch Reporting (Figure 2)

The system includes:

  • Audit trail includes user identification, time and date for initiation of cycle, cycle abort, cycle parameter changes, alarm acknowledgments, unsuccessful login login/access attempts, etc. Audit trail is viewable from the PC.
  • Local hard drive for storage of audit trail and batch cycle data
  • Batch reporting: predefined batch report in PDF format, batch report may be exported or printed using remote printer
  • Ethernet port: Batch data and audit trail can be exported to a customer supplied control system in CSV format. Batch data can be exported in PDF format. Data registers can also be read from the PLC via Ethernet
  • Password Protection: password protection features including unique access levels, aging, alpha numeric requirements, automatic log-out, etc.
  • E-signature: E-signature for final batch verification/acceptance is available

Electronic Data Security with Data Archiving and Enhanced Batch Reporting

Figure 2 – Electronic Data Security with Data Archiving and Enhanced Batch Reporting

These packages can help achieve faster process validation, more efficient operations, greater cost control and more importantly, comply with industry regulations for Electronic Data Security.

To learn more about pharmaceutical grade washers and sterilizers that are compatible with these solutions, please click:

http://www.sterislifesciences.com/Products/Equipment/Washing.aspx

http://www.sterislifesciences.com/Products/Equipment/Sterilization/GMP-Steam-Sterilizers.aspx


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Official blog of: INTERPHEX New York - www.interphex.com
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