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 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

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

What are the requirements in a Comprehensive EM Software System?

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

Manage System Users Multiple security levels Limited access Concurrency – Data integrity Event Notification

Set-up Test Protocols Controlled 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

Set-up Test Protocols Utilities Utility type – Clean steam – Water (Source,Lab, Purified,WFI, …) – Gas (CO 2, Compressed Air, Nitrogen, …) Valve/Port and Loop Test type (TOC, Bio-burden, Heavy metal (EP)) Specifications (alert, action, control) Scheduling Prepare/Review/Approve

Recurrence patterns

Set-up Test Protocols Personnel Monitoring Test type (Gowning, Finger dabs, …) Location Specifications Scheduling Prepare/Review/Approve

Personnel Monitoring

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

Mapping Import from other file formats Floor plan Test location definition

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

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

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

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

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

Microbial Identification Multiple Identifications File attachments Prepare/Review/ Approve

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

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

Statistical Output Trend basis – User – Location – Test type and location – Microorganism

Statistical Output Graphic display – Scatter plots – Bar charts – Pie charts – Regression analysis

Reports Default reports – Protocols – Summaries – Worksheets Company specific requirements – Logos – Custom formatting

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

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

Define lab requirements – Current state – Future improved state User requirements/Design specification – Gap – Configuration 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

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

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

Additional Information To request additional information about Novatek’s EM Software Application, you may contact: Aty Heidari Manager of Technical Sales Tel.: (514)