Reducing Errors in Life Sciences Content with Ann Rockley

@arockley www.rockley.com

©2014 The Rockley Group, Inc.

Reducing Errors in Life Sciences

Content: Adopting a Manufacturing

Paradigm

Ann Rockley, CEO The Rockley Group



The Rockley Group

• More than 15 years’ experience in Healthcare

• Clinical

• Labeling

• Promotional

• Industry experts

• Structured content strategy

• Content reuse

• Structured content management systems

• Content globalization strategy

• Multichannel delivery



Rockley customers



Ann Rockley

• Known as the “mother of content

strategy”

• Forefront of content strategy, reuse,

structured content management,

multichannel delivery (print, Web,

eBook, mobile)

• Passionately committed to defining

and sharing industry best practices

• Master of Information Science

• Fellow of the Society for Technical

Communication



Where errors happen

• Incorrect content used/reused

• Regulatory requirements are a moving target

• Inadequate reviews

• Missing claims

• Manual publishing



Incorrect content used/reused

Lack of version control

• Can’t find the latest copy

• Think you have the latest copy but there is really another that is more recent

• Naming conventions are obscure and inconsistent

• Multiple copies found and the dates aren’t really reflective of the currency of the content

• Content is frequently stuck in shared and tracked in email, can’t tell what is the most current version

• Someone accidentally uses/copies an old version. (Incorrect content gets published, errors in the field, regulatory fines)

• Time is spent looking for the most recent version. (Stuck in email, on fileserver, in multiple folders)

• Common content isn’t common. (Variations of images, symbols, statements, text are similar but different)



Regulatory requirements

• Large number of regulatory requirements.

• Different requirements for multiple agencies, keeping track

of the differences is complicated.

• New people may not understand the requirements or know

where to find the correct information.

• Different people may respond differently to the same

requirement.

• Knowledge is dependent upon people

• Many companies create massive spreadsheets to track

variations



Inadequate reviews

• Reviewers see content over and over again and begin to

lose focus

• Roundtables are painfully long and reviewers may start to

skip them because they are so unproductive

• Often don’t get to confirm that review comments were

incorporated correctly

• May be no or insufficient in-country reviewers for content



Missing/incorrect claims

• Every claim must have supporting content to ensure

approval. Supporting content is often tracked manually.

• Claims are easily separated from their supporting content

across products and channels.

• Claims must be worded identically or with minimal change

to be approved. People create and recreate the claims

differently.



Manual publishing

• Once content is finally approved the content is manually

copied and pasted into each of the outputs (InDesign,

web)

• Content can be missed

• Wrong content can be copied

• Translated content can be copied into the wrong

language

• Content has to be meticulously proofed (often 300%)

• Word by word

• Sentence by sentence



Error prone/highly manual

• This is a highly manual, incredibly error prone series of

process

• Only reason there aren’t more errors is through the

diligence of incredible staff

• Long hours

• Tedious activities

• Wealth of knowledge



Unsustainable

• Dedicated though our resources are, this is unsustainable

• Cannot grow to meet increasing demands

• Fatigue can result in errors

• Turn-over can occur



Manufacture content, don’t

handcraft it!



Manufacturing model

• “Don’t recreate the wheel”

• Create modular reusable components

• Create consistently structured content so that it can be “mixed and matched” or reused as necessary

• Standardize approved content

• Reuse common content

• Establish repeatable processes

• Clearly defined workflow

• Automate as many processes as possible

• Hand-offs in workflow

• Publishing



Modular

• Content is chunked into components rather than

documents

• Modules that are unchanged that have previously been

translated are not translated again

• New/changed modules are translated when they are

approved, no need to wait for the entire “document” to be

complete

• A PDF of the section or document is provided to ensure

that sufficient context is available for effective translation

• When something changes, only the changed module

needs to be retranslated



Structure

• Content has identifiable structure

• Structure allows us to identify the type of content, not what

it looks like

• Inconsistent content can be made consistent through

structure

• Structured content is format neutral, any stylesheet can be

applied to content based on its structure



















Reusable: Create once, use

many

• Medical Devices: UDI attributes plus

• Pharma: Source to CCDS, USPI, PIL, SmPC, Dosing card,

Package

• Medical Communications: Core response plus source

reusable details

• Learning Materials: Source to presentations, handouts

• Promotional Materials: Source to presentations, brochures



Standardized reusable content

• Intended use

• Shelf life

• Dosing information

• Indications

• Contraindications

• Precautions

• Warnings

• Tasks

• Concepts (e.g., hypoglycemia)

• Images

• Intended use

• Symbol statements

• Warranty

• etc.



Variants

• Frequently there are variants based on regulatory

requirements/region

• Create the core

• Use reuse best practices to create the variants

• Conditions

• Variables

• Core plus variant



Supporting claims

• Supporting claims costs can be addressed through:

• Metadata (content management)

• Reuse



Automate publishing

• Content can be automatically “poured” into structured

templates

• Change the source, not the print, to ensure that content is

controlled

• Change the look and feel, no problem, simply re-pour the

content into the new layout

• Minor tweaking required

• Translated versions of content can be poured into

templates designed to accommodate the language

requirements



Empty structured label template



Automatically filled label



Print: Empty structured InDesign template

IFU



Automatically filled IFU



Manufacture content

• Content models

• Reuse strategy

• Metadata

• Workflow

• Collaborative review

• Structured content management



Content models

• Content models are developed in spreadsheets

• Content models identify:

• The semantic (structure with meaning) of the content

• The organizational structure

• How content can be assembled into deliverables



Labeling model (IFU)

Simplified version



Reuse strategy

• A reuse strategy identifies:

• What content can be reused

• How it can be reused (identically or with change)

• Who is allowed to change reusable content

• Where/when it can be reused



Reuse map



Metadata strategy

• A metadata strategy identifies:

• A taxonomy

• The allowable values for the metadata

• Where metadata is applied

• What is the minimum metadata that must be applied



Metadata



Workflow

• Workflow allows us to control our content throughout its

lifecycle

• Roles

• Tasks

• Interactions

• Dependencies

• Wait states

• Approvals

• Exceptions

• Tracking metadata (attributes)



Workflow



Collaborative review

• Adopt collaborative review

• Simultaneous review from anywhere in the world

• See each other’s comments

• Comment on comments

• Accept or reject comments

• Use comparative review to see differences

• Full audit trail of changes



Structured content management system

©Nathan Sawaya http://www.fastcocreate.com/1682144/making-lego-into-art-nathan-sawayas-impossible-brick-sculptures#1

• Manages content at a granular (component) level of content, rather than at the page or document level.

• Each component represents a single topic, concept, or asset (such as an image or table).

• Components are assembled into multiple content assemblies (information products) such as a manual, IFU, service guide or help.

• Each component has its own lifecycle (owner, version, approval, use) and can be tracked individually or as part of an assembly.



Summary

• Despite our best efforts, errors happen

• Current processes are time consuming, error prone, and

unsustainable

• Manufacture content don’t handcraft it

• Create modular reusable components

• Create consistently structured content so that it can be

“mixed and matched” or reused as necessary

• Standardize approved content

• Reuse common content

• Establish repeatable processes

• Automate as many processes as possible



Summary cont.

• Develop your content manufacturing process through:

• Content models

• Reuse strategy

• Metadata

• Workflow



Questions

Ann Rockley

[email protected]

@arockley

mailto:[email protected]

Technology

Reducing Errors in Life Sciences Content with Ann Rockley