Takeaways from PLA2024Europe

The #PLA2024Europe programme aimed to highlight the importance of the human factor in digital transformation with several presentations and panel discussions. We were pleasantly surprised by how much the audience welcomed these discussions and that the human aspect of DX projects has resonated so much.
The key takeaways from the engaging discussions and insightful presentations are diverse and this time very much centred on people. They emphasise the need for everyone in the company, from top to bottom, from the technicians on the shop floor to the business leaders, to be properly educated on the importance of data and quality.

Become a Data Citizen

“Digital transformation is not just about buying or upgrading technology, but also about creating a digital mindset”.

Strategic workforce planning (SWP) is therefore required to unleash organisational potential. The SWP concept presented by Andreas Steinle from Roche showed how important it is to align HR strategies and organisational goals and prepare for the future by adapting the work culture, adapting to change, and remaining attractive to existing and new talent.

This is the moment when Andreas challenged the audience to think about implementing a new training policy, because all employees of the organisation need to be trained not only in data integrity, but also in the importance of FAIR data, so that they become data citizens.

Digital Mindset Shift for successful DX journey

When attending the PLA® conferences, there are numerous opportunities to get in touch with solution providers. In the exhibition hall, networking sessions and sponsored workshops, discussions focused on products and systems that meet a need.

>While technology is an enabler of digital transformation, it is not the solution. A business transformation solution requires multiple skilled teams, a change management strategy and emphasises the need for employee training and cultural change.

However, to support the digital mindset shift, intuitive solutions with a simple user interface and a limited number of clicks to perform a procedure were mentioned several times to laboratory informatics providers.

Not everyone is willing to switch if they are already struggling with the simple login process, have forgotten their password and can be a potential risk factor in terms of data integrity and security for the organisation. On the other hand, companies cannot remain idle when they are competing for new applicants who bring new necessary skills and actively demand digitalised processes through modern technologies.

Quality Culture, part of Corporate Core Beliefs

Quality Culture does not come with an “On” button that magically transforms an organisation.  Thanks  to the presentations delivered by Bob McDowall and Marie Jorna, Quality Director, Data Integrity & Digitalization Center of Excellence at MSD Animal Health, it seemed obvious to everyone why a quality culture is important in an organisation.

Whilst Bob started straight away by saying that for him a culture of quality is the condicio sine qua non for data integrity. He makes it clear that it is the job of management with leadership responsibility to create a quality culture where employees understand that data integrity is a core value of the organisation and where employees are encouraged to identify and promptly report data integrity issues.

The Iceberg of Ignorance

The iceberg of ignorance has made it very clear that ultimately management needs to be more aware of how work is being done and what the problems are, e.g. through Gemba walks.

Every employee should have data integrity objectives in their job description

As an example, among other warnings, he cited the Stason and Tender Corp FDA warnings letters from July 2020, which stated: “Management needs knowledge of computer systems” – key for digitalisation projects!

“The Iceberg of Ignorance”, a study popularly attributed to consultant Sidney Yoshida concludes:  “Only 4% of an organization’s front-line problems are known by top management, 9% are known by middle management, 74% by supervisors and 100% by employees…”

Although the Yoshida study involved numerous mid-sized organizations, the basic findings tend to be the same in organizations of any size.

Here some extra reading from 2017 MHRA blog

• Too much pressure: a behavioural approach to Data Integrity (Part 1) – MHRA Inspectorate (blog.gov.uk)
• Too much pressure: a behavioural approach to Data Integrity (Part 2) – MHRA Inspectorate (blog.gov.uk)

Quality Culture Definition

Complementing Bob in this session dedicated to quality culture, Marie Jorna from MSD Animal Health brought the perspective of quality officers working on educational initiatives across all facilities in her organisation.

She proposed a definition for quality culture: “habits, norms, values and standards of organisational behaviour that influence the quality of products”. However, from her experience, Marie also pointed out that building a common culture involves all cultures and subcultures, proposing customised training, creating a community of practise, spreading knowledge about the regulations, encouraging people to speak out.

The aim is to instil a sense of quality culture in everyone so that they become digital, gain efficiency and productivity while fully complying with regulations.

I am personally delighted that the human aspect of DX projects was so well received at PLA2024Europe.

We are grateful to all our #PLA2024Europe keynote speakers, presenters and panellists for being so open about their digital transformation experiences, challenges, benefits, reflections and conclusions.

Last but not least, this edition was also very special because we were able to welcome so many women on stage and in the audience.