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Online Training Workshop delivered via Microsoft Teams 
This 90-minute online session is designed for laboratory managers, IT administrators, compliance officers, and advanced users responsible for OMNIS system configuration, compliance, and data management.

£200 per company (up to 10 members from each company)

 

Course agenda

OMNIS Client/Server architecture

  • Centralised data storage and multi-client access
  • Data synchronisation and offline mode
  • Compliance and data integrity advantages of centralised management

Data integrity & security 

  • Traceability and integrity of analytical data
  • RFID-tagged reagents and automated logging
  • System safeguards: audit trails, electronic signatures, user authentication
  • Overview of compliance features (FDA 21 CFR Part 11, EudraLex Annex 11)

Data export & data areas

  • Exporting results, raw data, and audit trails (CSV, PDF)
  • Data export routines for LIMS/third-party integration
  • Understanding OMNIS data areas: samples, subsamples, operating procedures, methods, results
  • Data backup and restore for disaster recovery

User rights & management

  • Setting up user accounts, groups, and roles
  • Assigning permissions for data access and editing
  • Active Directory integration for enterprise user management
  • Password policies, account security, and auditability

Electronic signatures 

  • Applying/managing signatures on methods, procedures, and results
  • Two-level signature workflows for approval and compliance
  • Protecting signed objects and ensuring regulatory compliance
  • Signature traceability in OMNIS

Audit trail 

  • Automatic recording of critical actions and changes
  • Searching, filtering, and exporting audit trail entries
  • Audit trail integrity checks and archiving
  • Using audit trails for troubleshooting, compliance, and process improvement

Compliance mapping & Q&A 

  • Mapping OMNIS features to:
    - FDA 21 CFR Part 11 (electronic records/signatures)
    - EudraLex Annex 11 (computerised systems in pharma)
    - General data integrity principles (ALCOA+)
  • Open Q&A

Sign up for this Training Workshop

To book onto this Training Workshop please fill out the form below and our Training Manager will contact you