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
Utilities and Controlled
Environment

Manage users
 Register and schedule tests
 Generate summaries
 Distribute worksheets
 Enter results
 Statistical analysis
 Reporting
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 (CO2, 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

–Equipment
–Product lot number
–Media lot number
Data entry using bar-codes
 Complete/Review/Approve
Handling Excursions

Designating excursion values
– Pathogenic
– Alert/Action/Control levels

Visual cue
 Differentiation between spec levels
 Email 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
EM Software Implementation

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
E-mail: Aty.Heidari@ntint.com
Tel.: (514)336-6809