Co-Developing and Implementing a Content Strategy Focued on User Experience Rather Than Pure Regulatory

Case Study: Co-Developing and Implementing a Content Strategy

focused on User Experience rather than pure Regulatory Compliance

Patrice Fanning, Founder, TWi Ltd.

AGENDA

www.technicallywriteit.com

Setting the context Building the business case Defining the content strategy Testing the waters Working as part of a global and

remote team Supporting as an independent third

party


The No. 1 European location for international pharmaceutical investment 9 of the top 10 pharmaceutical companies have a presence here 7 of the world’s top 10 selling drugs are produced here Home to over 100 companies engaged in biological, pharmaceutical, and

chemical related activities Over 25,000 people are directly employed in the sector

Source: ec.europa.eu/enterprise-europe-network

Setting the Context: TWi

Setting the Context: TWi

Founded in Cork in the South West of Ireland in 2011, TWi is a growing team of world-class communicators, committed to quality and continuous learning

Our mission is to make complex information as accessible and easy to consume as possible for the target users it is designed to benefit

Focus on forming long-term partnerships with large corporate clients who need scalable and fully managed documentation solutions to meet their changing requirements

Mainly in IT (software and hardware): SAP, Intel, EMC, Wacom, Salto


Setting the Context: Ireland


The No. 1 European location for international pharmaceutical investment

9 of the top 10 pharmaceutical companies have a presence here

7 of the world’s top 10 selling drugs are produced here

Home to over 100 companies engaged in biological, pharmaceutical, and chemical related activities

Over 25,000 people are directly employed in the sector

Setting the Context: The Client


Global R&D Operations team within leading pharmaceutical corporation responsible for hundreds of processes covering the end-to-end drug development cycle

Diverse range of products in the areas of oncology, immunology, neuroscience, infectious disease, as well as cardiovascular and metabolic disease

Existing process documentation focused on regulatory compliance, complete with extensive approval/audit trail Standard Operating Procedures (SOPs) Work Instructions (WIs) Training Videos

Setting the Context: Audience


Setting the Context: The Content


Available in multiple formats and tools

No agreed templates or styleguides

No central repository for content

Limited versioning in place

Setting the Context: The Content


Setting the Scene: Audience


Setting the Context: Audience


Building the Business Case


Identify metrics that can be measured before and after Time required to induct new employees and related cost Time required to train employees if they move department/team and cost Time required to prepare for an audit…and deal with the findings Error rates Productivity statistics

Reference case studies Identify the sponsors and stakeholders Speak business language to persuade Show the potential positive impact on the bottom line

Defining the Content Strategy: Value Streams


Identify how many distinct processes there are Divide them into four main value streams

Small Molecule Processes

Clinical Supply Chain Processes

Primary Container and Devices Processes

Large Molecule Processes

ChemicalWhite

powder

Pills

BiologicalEngineered

cells

Liquid

Logistics

Trial Mgmt

Delivery

Defining the Content Strategy: Process Inventory


Define complete process inventory Identify clusters of related processes in each value stream, with up to 7 levels to

illustrate granularity and define a comprehensive and meaningful hierarchy 724 processes in total, each linking to more detailed SOPs, WIs, training videos

Defining the Content Strategy: Template and Style Guide


Defining the Content Strategy: Workflow Diagrams


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Defining the Content Strategy: Workflows

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Defining the Content Strategy: Workflows

Defining the Content Strategy: Drupal Online Playbook


Modelled the process inventory in Drupal and used this as a central repository for publishing the final output in the form of an online playbook, which functions much like Wikipedia

Testing the Waters


Testing the Waters


A pilot project was run initially to assess the feasibility of the larger project, which is set to run for two years

20 processes selected (5 from each value stream) to pressure test the capabilities of the TWi team, as well as the client’s ability to support such an exercise

Testing the Waters


Testing the Waters


Reused content across processes where possible to minimise future maintenance effort Created and implemented HTML code to expand the capabilities of the WYSIWYG

editing tool in Drupal and uploaded and published the final documents to the live environment

Possibility to rate the content and provide feedback to trigger changes Successful proof of concept, with buy-in secured – all stakeholders felt the quality and

accessibility of the information had improved significantly

Working as Part of a Remote and Global Team


All TWi staff assigned to the project had virtual/remote VPN access to the client’s network, using Amazon Workspaces and Symantec VIP Access Codes

Use of internal email addresses and Skype for Business accounts on the client’s network Everybody using the same SharePoint structure with access to the up-to-date published

deliverables on Drupal Regular video conference and WebEx sessions Face-to-face week-long workshop for all those involved held in Ireland (from US,

Belgium, Holland, and Ireland) Clear roles and responsibilities established from the outset Ongoing expectation setting and management as milestones were reached

Supporting as an Independent Third Party


Supporting as an Independent Third Party


Expertise in developing content strategy and writing in a clear and user-friendly manner Lessons learned from client projects in other sectors, mainly ICT, MedTech, and Utilities

helped in developing a framework and plan Neutral/independent and able to transcend internal knowledge silos and office politics

and get people to see change as a positive Working with multiple teams in parallel to introduce a little bit of healthy competition We didn’t win every battle, most notably the one to use structured XML or DITA Increased productivity and reduced learning times as clear and comprehensive

documentation clarifies expectations and the flow both within and across processes

What The Client Said

‘TWi did an excellent job in driving us forward during the pilot project, giving great advice and insights on what we were trying to achieve. The writing team quickly came up to speed on the complex subject matter and offered a fresh, objective perspective. The questioning of our own dogma was superb and this really helped to mature our thinking.

TWi has greatly enhanced the usability of our content and built a great foundation of trust with our entire team, which makes for a smooth ongoing collaboration.’


Contact

Technically Write ITWest Building

Carrigaline Industrial ParkCo. Cork, Ireland

Ⓣ +353 (0) 21 2428800Ⓔ [email protected]Ⓦ www.technicallywriteit.com

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