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