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Accelerating Data Review in a Paperless Laboratory with ELN
Ron Shoup2011 AAPS National Meeting
Typical Paper Lab Notebook Pages
• The issues with paper:
– Searching for information in paper systems
– Printed methods and companion paper forms
– Detecting disconnects between various paper systems (equipment calibration expiration vs. use in study)
– Knowing when data is truly created in a paper system
– Knowing whether results are built from secured and validated resources
– Exhaustive QC checks to verify data
ELN Terminology• Validated Template- a predefined set of tables, requiring the
same information every time (similar to a paper form) that has been tested and approved.
• Experiment-– Any information placed in the ELN; placing a word
document into the ELN is an experiment– Any process performed using a validated template; for
example: balance checks, audits, equipment maintenance• Version History- the history of saves performed on an
experiment
Validated Templates Cover:
•Management Functions (3)
•Metrology Activities (6)
•Reagents, Standards, Materials (8)
•Training (2)
•Method Validation (7)
•Study Conduct (7)
•Sample Analysis (2)
•Quality Assurance (2)
Empty spreadsheet ready for use in experiment:
Completed spreadsheet:
Only approved templates allowed for regulated studies
Only designated method(s) can be applied to the study
Folders define one’s ability to execute, and where to execute
All staff can view any experiment, at any stage
Hierarchical controls:
• New sponsor in Watson sponsor hierarchy built in ELN
• New study in Watson study hierarchy built in ELN
• New analytical run in Watson new run built in ELN under Run Organizer folder of study
• Standardized sample names for all types of normal and validation samples
Seamless connection to Watson
Watson data autoloaded into validation experiment:
Recovery calculations, from knowing the run number and sample identifiers
• All ELN templates are validated and controlled• Use QA/QC resources up front instead of after
the fact• Auditing in the ELN requires Quality to think
about auditing in a new way and utilize the technology tools available to us, thus allowing “Audit by Exception”.
QC/QA Resources
Composition of “Audit By Exception”
• EWB View of Validated Template- Balance Check
• BSS View of Validated Template-Balance Check
Validated Templates (with
Quality and Management
review/approval)
Example of Status Table
• INCOMPLETE Status Table
• GOOD Status Table
Status Table
/Root/AIT Bioscience/Common Reagents/Executed Common Reagents Experiments/Water-ACN-FA, 10-90-0.1-01Nov2010-000690
• Scanned information is not appropriate and/or expired- BAD!
• Scanned information is appropriate and not expired- GOOD!
Field Checks
(automatic QC)
/Root/AIT Bioscience/Sponsor Node/0010/Sponsor Specific Template Lifecycle Library/2. Sponsor Specific Executed Experiments/0010-SS-001554
Field Checks
Audit Trail Example: Equipment Maintenance- oil change in pump
Audit Logs
/Root/AIT Bioscience/Common Equipment/Executed Common Equipment Experiments/EQM-BEQ.1113-21-Jun-2011-003
Audit Trail Example: Equipment Maintenance- oil change in pump
Audit Logs
Audit Trail Example: Equipment Maintenance- oil change in pump
Audit Logs
Electronic Report
Template
CRM
ELN
WATSON
• Unstructured like a paper lab notebook, but also…• Validated templates for repetitive tasks
– Business, scientific rules enforced– Error prevention during the lab activity
• Hierarchical organization for organizing facility records and studies
• Role-based permissions to create, add to, change records
• Records immediately viewable by all• “Audit by exception”
Advantages for AIT with an ELN