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User requirements of a comprehensive ENVIRONMENTAL MONITORING software system

User requirements of a comprehensive ENVIRONMENTAL MONITORING software system. Susan B. Cleary. Current Practices. Legacy systems pre 1997 Spread sheets non-compliant In-house systems Maintenance / upgrade / Regulatory changes. Benefits of a Comprehensive System.

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User requirements of a comprehensive ENVIRONMENTAL MONITORING software system

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  1. User requirements of a comprehensive ENVIRONMENTAL MONITORING software system Susan B. Cleary

  2. Current Practices • Legacy systems • pre 1997 • Spread sheets • non-compliant • In-house systems • Maintenance / upgrade / Regulatory changes

  3. Benefits of a Comprehensive System • All data is managed and contained in one system. (for all sites) • All data can be easily analyzed expediting problem detection • Data integrity and security • Regulatory compliance

  4. User Requirements • Specific (easily understood) • Attainable (realistic) • Prioritized • Traceable • (requirement ~ design ~ validation) • Compliant to 21 CFR part 11

  5. What are therequirements in a Comprehensive EM Software System?

  6. Define the Workflow Utilities and Controlled Environment • Manage users • Register and schedule tests • Generate summaries • Distribute worksheets • Enter results • Statistical analysis • Reporting

  7. Manage System Users • Multiple security levels • Limited access • Concurrency • Data integrity • Event Notification

  8. Set-up Test ProtocolsControlled Environment • Test type (Rodac, Settle plate, Air sample,…) • Viable (Bacteria,Yeast/Mold) • Non-Viable (Particle counts) • Location • Location classification • Static/Dynamic specifications • Static/Dynamic scheduling • Prepare/Review/Approve

  9. Set-up Test ProtocolsUtilities • Utility type • Clean steam • Water (Source,Lab, Purified,WFI, …) • Gas (CO2, Compressed Air, Nitrogen, …) • Valve/Port and Loop • Test type (TOC, Bio-burden, Heavy metal (EP)) • Specifications (alert, action, control) • Scheduling • Prepare/Review/Approve

  10. Recurrence patterns

  11. Set-up Test ProtocolsPersonnel Monitoring • Test type (Gowning, Finger dabs, …) • Location • Specifications • Scheduling • Prepare/Review/Approve

  12. Personnel Monitoring

  13. Mapping • Room template • Personnel template • Adding test locations • Multiple rooms • Secure file storage • Audit trail

  14. Mapping • Import from other file formats • Floor plan • Test location definition

  15. Bar-coding • Sample tracking • Labels • Fonts (code 128, code 39) • Self contained • Configure with existing labeling

  16. Generating Summary Sheets • Creating only what is required • Based on protocol scheduling • Static or dynamic specs

  17. Distribution of Worksheets • Scheduled testing lists • Printed maps • Bar code labels • Sample status

  18. Data entry • Data organization and the effect on data entry • Detail data entry • Incubators • Exposure times • Personnel contact • Data entry using bar-codes • Complete/Review/Approve • Equipment • Product lot number • Media lot number

  19. Handling Excursions • Designating excursion values • Pathogenic • Alert/Action/Control levels • Visual cue • Differentiation between spec levels • Email notification • Investigation initiation prompt

  20. Microbial Identification • Multiple Identifications • File attachments • Prepare/Review/Approve

  21. Investigations • Action • Follow-up • Final decision • Completion and approval • Visual cue • Master list

  22. 21 CFR part 11 • Electronic signatures • Time stamps • User logs • Change controls • Audit trails • Record retention (Back up and Archiving)

  23. Statistical Output • Trend basis • User • Location • Test type and location • Microorganism

  24. Statistical Output • Graphic display • Scatter plots • Bar charts • Pie charts • Regression analysis

  25. Reports • Default reports • Protocols • Summaries • Worksheets • Company specific requirements • Logos • Custom formatting

  26. Free Format Query • Dynamic field selection • Alpha or numeric field detection • Graphic display • Printed report

  27. Archiving • Free-up current database space • Access the data on demand • Storage of past data • Audit trail • Version control

  28. EM Software Implementation • Define lab requirements • Current state • Future improved state • User requirements/Design specification • Gap • Configuration

  29. EM Software Implementation • Training by user type • Power users (system administrators) • Standard users • Three phase training • Demonstration • Hands on • Question and Answer • Evaluation and sign off

  30. EM Software Implementation • Validation • Installation Qualification • Operational Qualification • Performance Qualification • Traceability matrix • Standard Operating procedures (back up/recovery)

  31. EM Software Implementation • Gap Analysis • Defending the system • Meets with internal SOPs • Measure performance • Increased lab productivity

  32. Additional Information To request additional information about Novatek’s EM Software Application, you may contact: Aty Heidari Manager of Technical Sales E-mail: Aty.Heidari@ntint.com Tel.: (514)336-6809

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