User requirements of a comprehensive

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 Novateks
  EM Software Application, you may contact
• Aty Heidari
• Manager of Technical Sales
• E-mail Aty.Heidari_at_ntint.com
• Tel. [phone]