APS 2012 Meeting

Tailoring ELN Workflows to the Variations in

Regulatory Requirements for Contracted

Studies Ron Shoup, April Pisek, Jessica White, Brian Beato

Historical Background on AITB’s

ELN Implementation

4Q 2009 Completed evaluation of 3 ELN products, purchased IDBS E-Workbook

1Q 2010 Extensive initial training; wrote user requirements for approximately 20 workflows to create templates

2Q-3Q 2010 Template creation, administrative operations decisions

4Q 2010 Validation of templates and hierarchy

2Q 2012 Over 60 templates now validated

ELN’s aren’t “Lab in a Box”

• IDBS E-Workbook Suite A powerful platform of infinite possibilities (especially if you have

infinite patience and resources!)

Similar to a pile of Legos (what do you wish to build?)

Many ELN implementations remain underutilized due to complexity.

• Certainly can use a product quickly as a

“post-it” lab notebook, which offers search

functionality, common access to information,

organization of data.

• But enforcing workflows using forms and

building validated resources to automate

calculations was more valuable to us.

How Far to Develop?

Integrating Disparate Workflows into a

Single System

Mgmt. Functions (3)

Metrology Activities (5)

Reagents,

Standards,

Materials (9)

Method Validation (10)

Training (2)

Study Conduct (8)

Sample Analysis (2)

Quality Assurance (3)

Study

Report

Writing (2)

LBA (12)

Numerous Tools Customized

Tabulation

and Analysis

Hooks to

Watson LIMS

• Unstructured option, like a paper notebook

• Validated templates for repetitive tasks

– Business & scientific rules enforced

– Error prevention in real time

• Hierarchy organizes & segregates information and data

• Role-based permissions to create, add to, change records

• Records immediately viewable by all permitted

• Secure links to other databases such as Watson LIMS

Implementation Features

Electronic forms deliver on expectations:

A blessing and a curse….

We created a fully validated system with pivotal

bioequivalence study inspections in mind…BUT did we

overbuild?

Ex: How do we perform discovery studies when

compounds are uncharacterized?

“Audit by exception” was too tightly wound!

Receive reference standard

Create calibration and QC samples

Make stock and spiking solutions

Perform method validation run (first of many)

Day 1 Day 2

Solutions expired by

default

QC samples expired by

default

Subsequent method validation runs

blocked

• List the labels and fields for each variation of

the desired template.

• Determine whether an entry is required and

how to check the response.

• Create flowchart to organize the business

logic to be implemented.

• Review field checks and mandatory entries

before allowing the experiment data to be

published.

Building Templates to Mimic

Workflows

Fewer mandatory entries for experiment completion:

“Field checks” are conditional to allow nonregulated activity:

Strategy:

• Use a Study Summary experiment to declare

general information about the project.

• Use the Study Summary declarations when

executing the business logic behind

experiments related to the study.

• Use the information to allow or disallow

supporting experiments.

Study Type?

Establish Method

Sample Analysis

PI creates Study

Summary experiment:

Perform experiments

as required to

establish the method

Templates created for:

Standards, solutions,

extraction method,

instrument analysis…

Method

Development

Method

Validation

Long Term

Stability

Sample

Analysis

Study Type? Sample Analysis

PI declares in Study

Summary experiment:

method/version,

regulatory status

Perform Sample Prep and

Instrumental Analysis experiments as

required to assay the samples

Regulated? No

unregulated assets

can be involved in

study

Non-regulated?

Either type of asset

can be involved in

study

Establish Method

• Consider workflow variations as function of

regulatory requirements.

• Test forms on paper

• Create templates with correct business logic,

mandatory entries, and field checks

• Control use of templates by hierarchy

relationships

Design Strategy Summary

• Switchable between different levels of

regulatory scrutiny

• Can use the same templates for R&D,

validation, sample analysis

• Discovery data can be segregated to prevent

misinterpretation as part of the final report

• All remains searchable

• All calculations, equipment notes, and other

details remain accurate

Advantages of Multidimensional

Templates

rshoup@aitbioscience.com